Upstate Medical University

Clinical Trials

Active Clinical Trials

A Phase 2a Dengue Human Challenge Model (J2A)

Now Enrolling – Volunteer for Trial »

A Phase 2a Dengue Human Challenge Model (J2A)

For this study, we are looking at an anti-viral medication intended to treat Dengue Virus. We will be measuring how the medication acts on the body and how long it remains. In order to evaluate this medication, we will be giving you a weakened form of the dengue virus and measuring the effect of the medication against the virus. We have tested this weakened form of the virus here at Upstate and have experience managing participants who receive this virus which likely induces a mild form of dengue symptoms. Since there is currently no specific treatment available for dengue, we think this study can help us better understand a disease that impacts thousands of people every year across the globe.

About the Study:

A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of Repeated Oral Doses of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants

JNJ-64281802 is a novel, potent, pan-serotypic small-molecule inhibitor of dengue virus (DENV) targeting DENV nonstructural protein (NS)4B. JNJ-64281802 is being developed for the prevention and treatment of dengue infection. Dengue is caused by any of the 4 antigenically distinct DENV serotypes (DENV-1, -2, -3, and -4), which belong to the genus Flavivirus in the family of the Flaviviridae. The DENVs are human pathogens which are transmitted through the bite of an infected female mosquito of the genus Aedes. It is estimated that there are 390 million DENV infections globally per year, of which 96million manifest clinically (with any severity of the disease). Onaverage, each year about 500,000 dengue cases require hospitalization due to severe and life-threatening diseases and up to 25,000 patients die due to dengue. According to the World Health Organization (WHO), dengue is among the top 10 threats to global health in 2019. Currently, there is no dengue-specific treatment available and thus, clinical treatment is principally supportive in nature. In December 2015, the first vaccine against DENV was licensed. The chimeric yellow fever – DENV tetravalent dengue vaccine (CYD-TDV; Dengvaxia®) is a live attenuated vaccine. The widespread use of the vaccine, however, is not foreseen per WHO working group for immunization, as a number of factors need further consideration. During recent years, development of drugs for prophylactic use is slowly getting more attention as potential alternatives to prevent dengue. Prophylaxis could be beneficial for travelers to dengue-endemic regions (eg, aid workers, tourists, business and military travelers, and expatriates), as well as for vulnerable populations living in dengue-endemic regions. By preventing viremia and/or reducing viral load (VL), DENV infection-associated morbidity and mortality could be reduced remarkably or even prevented. In addition, an efficacious and safe prophylactic anti-DENV compound could also be used as a therapeutic agent.

Study Info and Commitment:

  • Looking for adults 18-50 years old with no chronic medical conditions
  • Taking any form of medication? Exceptions are Tylenol and hormone replacement therapy.
  • Must agree to be seen in the clinic for 31 outpatient visits in 35 days. Visits are approximately 2 hours. 2 visits on the first and last dosing day are 15 hours long.
    • Once a week visit for 6 weeks
    • One final visit 2 weeks after
    • All visits will be about 2 hours long
  • You will get up to $4875 for taking part in this study. Here is how the payments will work:

$100 for each completed visit in the research clinic, except for Day -5 and Day 21.

$200 for each completed visit on Days -5 and Day 21.

$25 for each completed scheduled phone call.

$200 for each day of hospitalization.

  • Total length of study participation is 6 months
  • This study is blinded. All subjects will receive DENV injection, however not all subject will receive anti-viral medication. Some will receive a placebo
  • There are some important lifestyle modifications, including decreasing alcohol use, caffeine, other dietary restrictions, and limits on strenuous physical activity for 7 months. Will discuss additional modifications at the end of this call.
  • FEMALES: You cannot be pregnant or breastfeeding or planning to become pregnant. You must also agree to use a highly effective form of birth control
  • MALES: Must agree not to father a child for the duration of the study and agree to use a condom
  • We will conduct ECGs, blood draws and collect urine samples. Blood samples are collected at each visit.
  • You will get up to $4875 for taking part in this study. Here is how the payments will work:

$100 for each completed visit in the research clinic, except for Day -5 and Day 21.

$200 for each completed visit on Days -5 and Day 21.

$25 for each completed scheduled phone call.

$200 for each day of hospitalization.

Exclusion Criteria:

  • History of liver or renal impairment
  • Allergic reaction to a previous vaccination, or allergic to including shellfish, fetal bovine serum, L-glutamine, neomycin, and streptomycin
  • Has taken an investigational medication or vaccine through a research study within the last 6 months.
  • Currently enrolled or planning to enroll in an investigational trial within 90 days after last dose of study drug
  • Positive for HIV, HEP B, HEP C, or flaviviruses including, DENV, Japanese encephalitis virus, West Nile virus, Yellow Fever virus, and Zika virus
  • Travel to region with Yellow Fever virus (Asia) or received a Yellow Fever vaccine in the past
  • Travel to a region with DENV within 4 weeks or definite plans to travel to a DENV region during the course of the study.
  • Received or plans to receive:
  1. Licensed live attenuated vaccines – from 28 days before first dose of study drug until 28 days after last dose of study drug. This includes influenza
  2. Other licensed (not live) vaccines – from 14 days before first dose of study drug until 14 days after last dose of study drug.
  • Dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria in the last 5 years
  • Having donated or lost >1 unit of blood (500 mL) within 60 days or >1 unit of plasma (250 mL) within 7 days before first dose of study drug, or having the intention to donate blood or blood products during the study or within 6 months after last dose of study drug.
  • Use of any CYP3A4 inhibitors
  • Immunodeficiency or any immunosuppressive drugs
  • Significant alcohol or drug dependency within the last 12 months
  • BMI <30 (ask for height and weight-BMI calculator)

Become a Volunteer >

 

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Dengue Human Infection Model (DHIM-3)

Now Enrolling – Volunteer for Trial »

DETAILS – Dengue Human Infection Model (DHIM-3)

The purpose of this research study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so, in the future, we can use it to test whether or not a new vaccine or drug for dengue actually work. This study will last 6 months and have approximately 18 visits to our office.

Study Title:

Phase One, Open Label Assessment of a Dengue-3-Virus-Live Virus Human Challenge – (DENV-3-LVHC) Virus Strain

About the Study:

Dengue is a disease caused by a virus. A certain type of mosquito transmits the virus. When a mosquito carrying dengue virus bites someone, he or she can get sick with a dengue infection. These infections can be very mild, with little or no symptoms, but may cause fevers, severe headache, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is referred to as an uncomplicated dengue infection. Occasionally the dengue infection can be severe and cause bleeding (hemorrhagic fever) and/or a sudden decrease of the blood pressure (shock). Severe reactions to natural dengue infections are uncommon and occur in less than 1% of all first infection cases. A severe infection from a natural dengue infection can cause death in some cases, mainly in children.

There are 4 types of dengue virus (1, 2, 3, and 4). Each one can make you sick. You usually cannot get sick from the same type twice. You can, however, get sick again if your second infection is with a different type of dengue. Second infections with a different type of dengue may have a more severe illness.

The types of mosquitoes that carry and transmit dengue virus are most frequently found in the tropical areas of the world (for example the Caribbean, South America, Asia, Puerto Rico, and Hawaii). They are present in some southeastern states in the United States (for example, Florida, Texas, Louisiana, Mississippi, Georgia). Except in rare instances, the mosquitoes present in the United States do not have the dengue virus. Therefore, there is a very low risk of contracting the disease in the continental United States compared to areas of the tropics where the disease is commonly present. While an outbreak of dengue occurred in Key West, Florida in 2009-2010, most dengue cases in US citizens are reported from people living in Puerto Rico, the US Virgin Islands, Samoa, and Guam or from travelers coming back from tropical areas. Dengue is now the leading cause of fever-causing illness in US travelers returning from the Caribbean, South America, and Asia.

This study involves injection with a weakened form of dengue virus type 3, using 1 of 3 possible dosage strengths (low, medium, or high). There are no specific treatments (antibiotic or antiviral medications) available for dengue infection, but other supportive care will be provided, if required. Supportive care may include: medication for management of pain, fever reducing drugs (acetaminophen), the management of fluid loss through oral or intravenous hydration, close monitoring and clinical assessment by a physician, and fluid replacement if required. This supportive care follows the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines.

The purpose of this research study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work. For instance, in the future, we could give a subject a new dengue vaccine then give them the weakened dengue virus. If they do not develop dengue symptoms the vaccine may be working. If they do have dengue symptoms the vaccine may not be working. This weakened dengue virus could also be used to look at how the body’s immune system reacts to a dengue infection.

Giving a controlled infection to test vaccines or to look at the immune system is done for a number of diseases including malaria. It has been done with dengue viruses in the past. The weakened version of the dengue virus we are using in this study is newly produced, so now we need to carefully study the ways in which this new weakened dengue virus causes illness. We also want to ensure that it can safely cause a mild form of dengue illness that can be used in future research.  If you participate in this study, we expect that you will develop symptoms of dengue infection.

We plan to enroll up to 27 subjects in the study. The subjects will be divided into 3 groups who will receive 1 of 3 different doses of the virus, beginning with the lowest dose. Each dose group will enroll up to 9 subjects. If safety issues are found with 1 of the doses, the higher doses will not be given.

Qualifications:

To be eligible for this study you must:

  • Be at least 18 years old and no more than 45 years old at time of consent
  • Be able to read, sign, and date this informed consent
  • Score at least 75% correct on test of your understanding of the information in this informed consent form
  • Provide consent for release of medical history records
  • Be in good health, as determined by medical history and physical examination
  • Not have significant physical findings prior to inoculation
  • Have negative urine screen for cocaine, amphetamines, or opiates
  • Not plan to participate in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding inoculation, during the study period, or in the 6 months following inoculation
  • Not be planning to become pregnant or father a child for the duration of the study (6 months) and using contraceptive methods to prevent pregnancy
  • Not have active Diabetes or active peptic ulcer disease
  • Not have chronic obstructive pulmonary disease or coronary artery disease
  • Not have a history of, or current, auto-immune disease
  • Not have a history of Guillain-Barré syndrome
  • Not have been diagnosed with Bipolar Disorder or Schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study
  • Not have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus.
  • Have negative blood tests for the presence of antibodies to dengue, West Nile, Yellow Fever, Japanese encephalitis and Zika virus
  • Have negative blood tests for HIV-1, Hepatitis B, and Hepatitis C
  • Not plan to be vaccinated for any flavivirus
  • Not have traveled within the past 4 weeks to an area where dengue infections occur naturally
  • Not have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination within 4 weeks following inoculation
  • Not have had medicines or therapies that suppress your immune system
  • Not currently be taking anti-coagulant medication, non-steroidal anti-inflammatory
  • Not currently taking Methadone or Suboxone
  • Not have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish, Fetal Bovine Serum, L-Glutamine, Neomycin, and Streptomycin
  • Not have a history of chronic migraine headaches
  • Not have a recent blood donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection
  • Not planning to receive blood products or antibodies within 56 days of inoculation or during the study period
  • Not have beliefs that prohibit the administration of blood products or transfusions
  • Non-pregnant or non-lactating
  • Not be using an intrauterine device or intrauterine system
  • Not have had heavy menstrual bleeding within the last 6 months

Have no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring

Become a Volunteer >

Antiplatelet Therapy in TIA and Ischemic Stroke Survivors

Now Enrolling – Volunteer for Trial »

DETAILS – Antiplatelet Therapy in TIA and Ischemic Stroke Survivors

The purpose of this study is to establish the safety and feasibility of using a personalized medicine approach to select a blood thinner (also called an antiplatelet drug) based on a person’s specific characteristics (such as: age, diabetes status) and genetic information instead of prescribing a blood thinner by the usual standard care (one size fits all approach). This study will last 1 year and have 3 to 7 visits to our office.

Study Title:

Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT). A Randomized, Phase II, Open Label, Trial in High Risk Transient Ischemic Attack (TIA) and Ischemic Stroke Survivors Age 18 Years and Older

About the Study:

The purpose of this study is to establish the safety and feasibility of using a personalized medicine approach to select a blood thinner (also called an antiplatelet drug) based on a person’s specific characteristics (such as: age, diabetes status) and genetic information instead of prescribing a blood thinner by the usual standard care (one size fits all approach).

This is important to doctors who care for stroke and TIA patients because we prescribe these medications to prevent recurrent stroke. All medicines used in this study are FDA approved.

Currently, patients receive aspirin and clopidogrel (also known as Plavix) for 21 days (unless there is a reason for not prescribing this). At the end of the 21 days, providers select from one of the available antiplatelet medicines (aspirin, clopidogrel, aspirin plus extended release dipyridamole [ASA-ERDP], or ticagrelor) and start patients on that medication.  If a patient does not tolerate the medication, the provider may stop that medication and try a different one. 

We plan to enroll 90 subjects in the study, being conducted at Upstate Medical University.

However, if we need to, additional subjects may be added to ensure we have 60 individuals who at least complete all the visits through 90 days after their stroke.

Qualifications:

To be eligible to participate in this study, an individual must meet all the following criteria:

  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Meet criteria for a World Health Organization Stroke or CLINICAL Stroke or High-risk TIA
  • Ischemic stroke: NIHSS ≤ 14 at the time of randomization (mild & moderate only)
  • Ability to randomize within 30 hours of stroke symptom onset/last seen normal time

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Evidence of new or prior non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage, or subdural hemorrhage on initial head computed tomography
  • Evidence of a CNS tumor, abscess, intracranial aneurysm or vascular/structural malformation, or any neuroinflammatory, neuroinfectious, or neurodegenerative disorder on neuroimaging or exam that could confound a participant’s functional outcome
  • Isolated or pure sensory, visual changes, or “dizziness”/vertigo without evidence of AIS on baseline head CT or MRI.
  • Qualifying ischemic event is believed to be iatrogenic or procedure related
  • Required to take a specific antiplatelet medication for an indication other than ischemic stroke or high risk TIA during the study period that would prevent the investigator from following the study algorithm
  • Etiology of qualifying ischemic event is known to be cardioembolic
  • High likelihood that anticoagulation (e.g., warfarin, NOACs, Lovenox®) will be needed during the study period
  • High likelihood that carotid endarterectomy or carotid stenting will occur during the period of the study.
  • Pre-stroke mRS score ≥ 3
  • Simple FRAIL questionnaire screening tool score ≥ 3
  • Contraindication to aspirin, clopidogrel, Aggrenox®, or ticagrelor
  • Known allergy or hypersensitivity that would prevent the investigator from following the study algorithm
  • Any history of moderate to severe drug-induced adverse events
  • Renal insufficiency
  • Hepatic impairment
  • Class II, III, or IV New York Heart Association (NYHA) functional heart failure
  • Any history of bradycardia without pacemaker placement
  • Active obstructive lung disease
  • Any active hematologic disorder
  • Active bleeding diathesis
  • Any systemic hemorrhage or GI bleed in the 3 months prior to the qualifying stroke.
  • Active peptic ulcer disease
  • Women who self-report that they are pregnant or breastfeeding
  • Active alcohol or substance abuse or dependence
  • Inability or failure to provide informed consent.
  • Inability of the patient to adhere to study procedures and/or follow-up
  • Inability to swallow oral medications
  • Not willing or able to discontinue prohibited concomitant medications
  • Ongoing participation in another non-observational clinical study

 

Active Clinical Trials / Not Enrolling

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185

Now Enrolling – Volunteer for Trial »

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects

: For this study, we are looking to assess the safety of a new antibody intended to be used for COVID-19. This is a phase one study so we are looking at the safety profile of this product as well as how it behaves in the body.

This is a Phase 1, randomized, double-blind, placebo-controlled, ascending dose study of SAB‑185 in healthy subjects using 0.9% saline as placebo. The study will enroll a total of 28 healthy subjects (male and female) between 18-60 years of age.

Background Information

There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, and that has now been detected in many locations internationally, including cases in the United States. The virus has been named “SARS‑CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID‑19) as noted in FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‑19 Pandemic March 2020.

Beyond supportive care, there are currently no FDA-licensed treatment or prophylaxis options for COVID-19 and the related pneumonia caused by SARS-CoV-2. The FDA issued an EUA to Remdesivir to permit emergency use for treatment of COVID patients hospitalized with severe disease, but it is not licensed to use. SAB-185 (Human polyclonal anti-SARS-CoV-2 antibody) is an option for treatment of COVID-19. SAB biopharmaceuticals is conducting a study in collaboration with CSL Behring to study SAB‑185 (Human polyclonal anti-SARS-CoV-2 antibody) to treat patients with COVID-19. SAB-185 is generated from SAB’s proprietary DiversitAb™ platform producing large quantities of human polyclonal antibodies targeted specifically to SARS-CoV-2. SAB’s approach, leveraging hyperimmunized, genetically engineered cattle to produce fully human antibodies, enables a scalable and reliable production of targeted, higher potency neutralizing antibody product than has been previously possible.

All pre-clinical and clinical batches of SAB-185 will meet the same release specifications, including potency. SAB-185 lots produced for pre-clinical studies and the proposed clinical material will only differ in the number of inoculations of the transchromosomic (Tc) bovines prior to harvesting. Product safety is not expected to be impacted by use of material from subsequent inoculations as further increase of neutralizing titers of specific anti-SARS-CoV-2 antibodies is considered beneficial to patients.

Study Info and Commitment:

  • Looking for adults 18-60 years old
  • This is a blinded study that involves a placebo. Participants have a 5 out of 7 chance of getting the active antibody product
  • There are two screening visits, 11 outpatient clinic visits on days 1 (dosing day), 2, 5, 8 (dosing day), 9, 15, 22, 36, 68, 98.
  • Dosing days (there will be 2) is a longer visit as 60 – 90 minutes, depending on the group you are assigned to. Upon receiving the study product infusion, you will be asked to stay at the site for a minimum of 6 hours after the infusion, up to a maximum of 24 hours (this would entail an overnight admission to Upstate University hospital.
  • You will receive a memory aid to keep track of how you feel for the next seven (7) days.
  • FEMALES: You cannot be pregnant or breastfeeding or planning to become pregnant. You must also agree to use a highly effective form of birth control
  • MALES: Must agree not to father a child for the duration of the study and agree to use a condom
  • Payment info. Can be found below

Visit

Compensation amount

Screening

$100

Screening Day -5

$100

Day 1* Day 8* – dosing day

$200

Day 2, 5 (9, 12,15, 22, 36-after dosing day 2)

$100 Each visit

Days 68 & 98

$100 Each visit

 

Qualifications:

To be eligible for this study you must not have:

  • Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid arthritis, lupus, inflammatory bowel disease)
  • Chronic respiratory disease COPD, emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen
  • Chronic asthma requiring the use of oral steroids or hospitalization in the last six months
  • Renal failure or renal insufficiency requiring dialysis
  • Congestive heart failure or significant atherosclerotic disease (coronary artery disease or peripheral vascular disease)
  • Hypertension
  • Diabetes
  • Currently vaping or smoking or history of chronic smoking
  • BMI >35
  1. Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of SAB-185
  2. Known IgA deficiency or previous allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG)
  3. Positive for hepatitis B virus, hepatitis C, or HIV
  4. Ever screen positive for rheumatoid factor
  5. History of COVID-19 or positive antibody or PCR (nasal test)
  6. History of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin).

Become a Volunteer >

Antibody Analysis of Subjects participating in Convalescent Plasma Donation pr Treatment for COVID-19

Antibody Analysis of Subjects participating in Convalescent Plasma Donation pr Treatment for COVID-19

The purpose of this research study is to collect samples for the Upstate Medical University for Global Health and Translation Science (IGHATS) to see how your body reacts to COVID-19 infection over time or plasma treatment.

The purpose of this research is to collect blood samples from people who have recovered from COVID-19 infection and are donation plasma and from patients who are receiving convalescent plasma for the treatment of COVID-19.

We will use investigational assays to test your samples to look at how your immune system reacted to COVID-19 infection (donor) or to the treatment and how long the reactions lasted (recipient). If you were treated with convalescent plasma, we will also compare your body’s response to other information we collected during your treatment like the time it took before you needed a ventilator, you time on the ventilator, chest x-ray, changes in your laboratory values, days in the hospital and mortality.

We may use samples for other assays (test) in the future.

 

SARS-COV-2 RNA VACCINE

SARS-COV-2 RNA VACCINE

The purpose of this study is to evaluate the safety, tolerability and effectiveness of the vaccine in healthy adults. Currently there are no vaccines to prevent infection of COVID or approved antiviral drugs to treat it. The sponsor of this study has developed a vaccine and with the rapid transmission of COVID-19, the development of an effective vaccine is extremely important. This is a 2 dose, randomized and blinded study, meaning you could receive either the vaccine or a placebo. This is decided at random by a computer database, much like flipping a coin.

Brief Summary of this Study:

This is a research study involving both Pfizer and BioNTech. Pfizer and BioNTech are separate companies who are cooperating to perform this study. Pfizer is responsible for conducting this study. BioNTech is the regulatory sponsor of this study. Funding for this study is provided by BioNTech and Pfizer and Upstate Medical University will be paid to conduct this study.

A new respiratory disease appeared in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world. In January 2020, the cause of this disease was found to be a new Coronavirus; and the disease it causes was named COVID-19 (Coronavirus disease 2019). Since then, many companies around the World have quickly started to look for treatments and ways to prevent COVID-19. There are no currently licensed (U.S. Food and Drug Administration [FDA] approved for sale) vaccines or specific treatments for COVID-19.

Vaccines help your body to produce antibodies to help you to fight off a disease. This research study involves 3 investigational vaccines to prevent COVID-19, that will be given to healthy volunteers. “Investigational” means that the study vaccines are currently being tested.  They are not approved by the U.S. Food and Drug Administration (FDA). The vaccines are given by injection. The vaccines are all slightly different but work in the same way. The study will also test each of these vaccines at different dose levels (amounts of vaccine).

These vaccines do not contain the whole virus, or the parts of the virus that can make you ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded by fatty particles called lipids. They use your own cells’ protein making machinery to produce some, or all, of the spike protein seen on the outside of the virus. This spike protein, made by your own body, may help your body to produce antibodies to fight against COVID-19. We will check how many antibodies you make by taking blood samples and testing them

Study Info and Commitment

  • Must be 18-85yrs old and in good health (as determined by the investigator)
  • Must be willing and able to come in for all scheduled visits, and adhere to vaccination plan, lab tests and lifestyle considerations
  • First vaccination (First visit) then 2nd vaccination 19-23 Days after 1st visit or 56-70 days after.
  • After 2nd vaccination must be seen 2 weeks after, 1 month, 6 months, 12 months and then again 24 months after.
  • Must complete e-diary from Day1-Day 7 (after each vaccination)
  • Have to be observed 30 min after vaccination
  • Obtain medical records and medical history at initial visit
  • Urine pregnancy test (females only)-both vaccination visits
  • Nasal swab-both vaccination visits
  • Compensation: $100 per each outpatient visit

 

  • Contraceptive Use:

implantable progestin-only hormone contraception

intrauterine device

intrauterine hormone-releasing system

bilateral tubal occlusion

vasectomized partner

combined (estrogen and progestogen containing) or progestogen only hormonal contraception associated with inhibition of ovulation. Can be oral, intravaginal, transdermal or injectable

-abstinence

-male or female condom with or without spermicide

-cervical cap, diaphragm or sponge with spermicide

-a combination of male condom with either cervical cap, diaphragm or sponge with spermicide

-abstinent from heterosexual intercourse

  • Compensation: $100 per each outpatient visit

 

 

HIV-1 Treatment for Adults who are Virologically Supressed

DETAILS – HIV-1 Treatment for Adults who are Virologically Supressed

The purpose of this study is to determine the efficacy, safety and tolerability of two approved medicines, dolutegravir (DTG) plus lamivudine (3TC) taken together, compared with subjects taking their current tenofovir alafenamide (TAF)-based regimen (TBR) for the treatment of HIV-1 infected adults in whom the HIV-1 virus is currently suppressed. This study will last approximately 4 years and have approximately 20 visits to our office.

Study Title:

A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1 infected adults who are virologically suppressed

About the Study:

The purpose of this study is to determine the efficacy, safety and tolerability of two approved medicines, dolutegravir (DTG) plus lamivudine (3TC) taken together, compared with subjects taking their current tenofovir alafenamide (TAF)-based regimen (TBR) for the treatment of HIV-1 infected adults in whom the HIV-1 virus is currently suppressed. Recent data have shown that DTG + 3TC is as effective over 1 year as a 3-drug regimen in participants newly initiating therapy.  Since HIV medicines have to be taken life-long, it is very important to understand the long-term safety and tolerability of DTG + 3TC compared to TBR. To answer this important question the part of the study comparing DTG + 3TC to TBR has been extended to Week 148 (approximately 3 years) after which all participants will have the opportunity to switch to DTG + 3TC until completion of the study at Week 200 (approximately 4 years). You have been asked to take part in the study because you have HIV and the virus in your body currently is suppressed.  The two-drug regimen of DTG and 3TC is considered experimental and is not yet approved for doctors to treat patients with HIV.  About 750 men and women in 10 countries will take part in this study.

Qualifications:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

  • Aged 18 years or older at the time of signing the informed consent.
  • HIV-1 infected men or women.
  • Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12-month window, and one within 6 months prior to Screening.
  • Plasma HIV-1 RNA <50 c/mL at Screening.
  • Must be on uninterrupted ART for at least 6 months prior to screening.
  • Male or Female
  • Capable of giving signed informed consent

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
  • Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease.
  • Subjects with severe hepatic impairment
  • Unstable liver disease
  • Evidence of Hepatitis B virus
  • Anticipated need for any hepatitis C virus therapy during the first 48 weeks of the study
  • Untreated syphilis infection
  • History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
  • Ongoing malignancy
  • Subjects who in the investigator’s judgment, poses a significant suicidality risk.
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
  • Treatment with any of the following agents within 28 days of Screening; radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
  • Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP.
  • Use of any regimen consisting of single or dual ART.
  • Any evidence of major NRTI mutation or presence of any major INSTI resistance-associated mutation.
  • Any verified Grade 4 laboratory abnormality.
  • Any drug holiday during the 6 months prior to Screening
  • Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy

Effects of cART Long Term Exposure in HIV Infected Adults

DETAILS – Effects of cART Long Term Exposure in HIV Infected Adults

The purpose of this study is to determine what effects combination antiretroviral therapy has on brain function. There are concerns that long-term exposure to combination antiretroviral therapy may predispose the brain to injury especially in the older HIV infected subjects. The results from this study may provide further knowledge on how to best minimize the risks of brain injury due to HIV infection itself and those caused by the HIV drugs. This study will last for 2 years and have 5 visits to our office.

Effects of cART Long Term Exposure in HIV Infected Adults

Study Title:

Effects of cART Long-Term Exposure on Neuronal Function and Brain Microstructure in HIV Infected Individuals ART Naïve starting cART.

About the Study:

The purpose of this study is to determine what effects combination antiretroviral therapy has on brain function.  There are concerns that long-term exposure to combination antiretroviral therapy may predispose the brain to injury especially in the older HIV infected subjects.  The results from this study may provide further knowledge on how to best minimize the risks of brain injury due to HIV infection itself and those caused by the HIV drugs.

Approximately 190 subjects will take part in this study. Subjects will mainly be recruited from the University of Rochester. However, the University of Texas at Houston, SUNY Upstate Medical University- Syracuse NY, and Gay Men’s Health Crisis Center (GMHC), New York, NY will help with study recruitment. Subjects will be placed into one of three groups; HIV positive subjects starting antiretroviral treatment, HIV positive elite controllers, and HIV negative control subjects. Twenty subjects are expected to patriciate at upstate medical university.

Qualifications:

Potential study subjects need to fulfill the entry criteria below according to group assignment.

  • 18 years of age or older
  • Able to provide informed consent
  • Able/willing to undergo neuropsychological and imaging testing
  • The following laboratory values within 60 days prior to baseline: Hemoglobin >9 gm/dL, Serum creatinine < 2 x ULN, AST, ALT, and alkaline phosphatase ≤2x ULN.
  • Negative serum or urine pregnancy test within 3 days prior to baseline if female of reproductive potential
  • Smoking and use of caffeinated drinks will be monitored and time from last use recorded. Subjects will be instructed to avoid smoking and use of caffeinated drinks for at least 2 hours prior to the scheduled imaging section.

Group 1 HIV+:

  • HIV-1 infection as documented by HIV test or 2 HIV-1RNA values> 2000 copies/mL at a CLIA certified lab.
  • ARV drug naive and willingness to begin antiretroviral therapy or have started ARV by no more than 2 weeks from study entry

Group 2 HIV-:

  • HIV negative test within 6 months of enrollment

Group 3 Elite Controllers:

  • HIV-1 infection as documented by HIV test at a CLIA certified lab., HIV-1RNA values <1000 copies/mL x ≥2 years; CD4 ≥ 400 at screening; no AIDS defining conditions.
  • No ARV treatment within the last year prior to screening

Volunteers will be excluded from participating if they are/have:

  • Unable to provide informed consent
  • Severe premorbid or comorbid psychiatric disorders.
  • Dementia, Subjects that meet HIV-1-associated mild neurocognitive disorder or HIV-associated asymptomatic neurocognitive impairment will not be excluded.
  • Chronic seizures, stroke, head trauma resulting in loss of consciousness> 30 min, and multiple sclerosis.
  • Brain infection, brain neoplasm, space-occupying brain lesions requiring acute or chronic therapy. Subjects with any fungal meningitis, toxoplasmosis, progressive multifocal leukoencephalopathy or CNS lymphoma are excluded from participation.
  • Active alcohol and drug abuse or related medical complications within 6 months of study entry including but not limited to seizures, hallucinations, delirium tremens, or being in a detoxification program.
  • Any significant systemic condition that that can alter brain function.
  • Metallic implant, e.g., in skull, cardiac devices.
  • Claustrophobia

Dengue Human Infection Model Expansion

DETAILS – Dengue Human Infection Model Expansion

The purpose of this research study is to increase our understanding of how people respond to a low dose Dengue Virus injection. We want a weakened dengue virus so, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work. This study will last 6 months and have approximately 26 visits to our office.

Study Title:

Phase One, Open Label Expansion of a Dengue-1-Virus-Live Virus Human Challenge – (DENV-1-LVHC) Virus Strain

About the Study:

Dengue is a disease caused by a virus. A certain type of mosquito transmits the virus. When a mosquito carrying dengue virus bites someone, he or she can get sick with a dengue infection. These infections can be very mild, with little or no symptoms, but may cause fevers, severe headache, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is referred to as an uncomplicated dengue infection. Occasionally the dengue infection can be severe and cause bleeding (hemorrhagic fever) and/or a sudden decrease of the blood pressure (shock). Severe reactions to natural dengue infections are uncommon and occur in less than 1% of all first infection cases. A severe infection from a natural dengue infection can cause death in some cases, mainly in children.

There are 4 types of dengue virus (1, 2, 3, and 4). Each one can make you sick. You usually cannot get sick from the same type twice. You can, however, get sick again if your second infection is with a different type of dengue. Second infections with a different type of dengue may have a more severe illness.

The types of mosquitoes that carry and transmit dengue virus are most frequently found in the tropical areas of the world (for example the Caribbean, South America, Asia, Puerto Rico, and Hawaii). They are present in some southeastern states in the United States (for example, Florida, Texas, Louisiana, Mississippi, Georgia). Except in rare instances, the mosquitoes present in the United States do not have the dengue virus. Therefore, there is a very low risk of contracting the disease in the continental United States compared to areas of the tropics where the disease is commonly present. While an outbreak of dengue occurred in Key West, Florida in 2009-2010, most dengue cases in US citizens are reported from people living in Puerto Rico, the US Virgin Islands, Samoa, and Guam or from travelers coming back from tropical areas. Dengue is now the leading cause of fever-causing illness in US travelers returning from the Caribbean, South America, and Asia.

This study involves injection with a weakened form of dengue virus type 1, using the lowest dosage used in DHIM-1. There are no specific treatments (antibiotic or antiviral medications) available for dengue infection, but other supportive care will be provided, if required. Supportive care may include: medication for management of pain, fever reducing drugs (acetaminophen), the management of fluid loss through oral or intravenous hydration, close monitoring and clinical assessment by a physician, and fluid replacement if required. This supportive care follows the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines.

The purpose of this research study is to increase our understanding of how people respond to a low dose Dengue Virus injection. We want a weakened dengue virus so, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work. For instance, in the future, we could give a subject a new dengue vaccine then give them the weakened dengue virus. If they do not develop dengue symptoms the vaccine may be working. If they do have dengue symptoms the vaccine may not be working. This weakened dengue virus could also be used to look at how the body’s immune system reacts to a dengue infection.

Giving a controlled infection to test vaccines or to look at the immune system is done for a number of diseases including malaria. It has been done with dengue viruses in the past. The weakened version of the dengue virus we are using in this study is newly produced, so now we need to carefully study the ways in which this new weakened dengue virus causes illness. We also want to ensure that it can safely cause a mild form of dengue illness that can be used in future research.

Dr. Stephen J. Thomas from SUNY Upstate Medical University is the principal investigator (PI), which means that he is responsible for conducting the study. This study will involve up to 9 adults. 

Qualifications:

To be eligible for this study you must:

  • Be at least 18 years old and no more than 45 years old at time of consent
  • At least 75% correct on test of your understanding of the information in this informed consent form
  • For females only, non-pregnant or non-lactating
  • Not be planning to become pregnant or father a child for the duration of the study (6 months) and using contraceptive methods to prevent pregnancy
  • Not be using an intrauterine device or intrauterine system, including Mirena®, due to risk of heavy menstrual bleeding with these devices
  • Not have had heavy menstrual bleeding within the last 6 months
  • Have no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring
  • Be in good health, as determined by medical history and physical examination
  • Provide consent for release of medical history records
  • Not have significant physical findings prior to inoculation
  • Not have active Diabetes or active peptic ulcer disease
  • Not have chronic obstructive pulmonary disease or coronary artery disease
  • Not have a history of, or current, auto-immune disease
  • Not have a history of Guillain-Barré syndrome
  • Not have been diagnosed with Bipolar Disorder or Schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study
  • Not have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus.
  • Have negative blood tests for the presence of antibodies to dengue, West Nile, Yellow Fever, Japanese encephalitis and Zika virus
  • Have negative blood tests for HIV-1, Hepatitis B, and Hepatitis C
  • Not plan to be vaccinated for any flavivirus
  • Not have traveled within the past 4 weeks to an area where dengue infections occur naturally, and not have any planned travel during the study period (6 months)
  • Not plan to participate in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding inoculation, during the study period, or in the 6 months following inoculation
  • Not have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination within 4 weeks following inoculation
  • Not have had medicines or therapies that suppress your immune system
  • Not currently be taking anti-coagulant medication, non-steroidal anti-inflammatory
  • Not currently taking Methadone or Suboxone
  • Not have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish, Fetal Bovine Serum, L-Glutamine, Neomycin, and Streptomycin
  • Not have a history of chronic migraine headaches
  • Not have a recent blood donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection
  • Not planning to receive blood products or antibodies within 56 days of inoculation or during the study period
  • Have negative urine screen for cocaine, amphetamines, or opiates
  • Not have beliefs that prohibit the administration of blood products or transfusions
  • Be able to read, sign, and date this informed consent

HIV-1 Treatment using a Long Acting Single Agent

DETAILS ? HIV-1 Treatment using a Long Acting Single Agent

This study will help us to find out how safe and how well the study product, PRO 140 monotherapy works in comparison to the combination of oral antiretroviral drugs for the maintenance of viral suppression in HIV-1 patients. This study will last for approximately 1-2 years, depending on your response to the treatment and have approximately 54 visits to the office.

Study Title:

A Multicenter Study to Assess the Clinical Safety and Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects with CCR5-tropic HIV-1 infection.

About the Study:

This study will help to find out how safe and how well the study product, PRO 140 monotherapy works in comparison to the combination of oral antiretroviral drugs for the maintenance of viral suppression in HIV-1 patients.

The safety and effectiveness of PRO 140 has been previously evaluated in 174 people in previous studies. The product used in this study is an investigational drug. An investigational drug is one not approved by the U.S. Food and Drug Administration (FDA). The results of these studies will be used to design future studies to improve treatment of HIV-1 infection.

About 500 subjects will enroll in the study across 60 centers within the USA. Approximately 10 subjects will enroll at SUNY Upstate Medical University.

Qualifications:

Potential subjects are required to meet all of the following criteria for enrollment into the study.

  • Males and females, age ?18 years
  • Receiving combination antiretroviral therapy for last 24 weeks
  • No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between Screening Visit and First Treatment Visit.
  • Subject has two or more potential alternative approved antiretroviral drug options to consider.
  • Documented Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile? DNA Assay
  • Plasma HIV-1 RNA < 50 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 Quantitative, RNA (Taqman? Real-Time PCR)
  • No documented detectable viral loads within the last 24 weeks prior to Screening Visit
  • CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy
  • CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at Screening Visit
  • Laboratory values at Screening that meet protocol criteria.
  • Clinically normal resting 12-lead ECG at Screening Visit
  • Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception. Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
  • Willing and able to participate in all aspects of the study.

Potential subjects meeting any of the following criteria will be excluded from enrollment.

  • CXCR4-tropic virus or dual/mixed tropic virus determined by the Trofile? DNA Assay at the Screening Visit
  • Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen
  • Any active infection or malignancy requiring acute therapy
  • Laboratory test values ? grade 4 DAIDS laboratory abnormality.
  • Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  • Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  • Any vaccination within 2 weeks prior to the first study dose.
  • Subjects who have failed on a maraviroc containing regimen.
  • Subjects weighing < 35kg
  • History of anaphylaxis to any oral or parenteral drugs
  • History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin)
  • Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  • Any known allergy or antibodies to the study drug or excipients
  • Treatment with any of the following:
  • Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
  • Immunosuppressants within 60 days prior to the screening visit
  • Immunomodulating agents, hydroxyurea, or foscarnet within 60 days prior to the screening visit
  • Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception, subjects on inhaled, nasal, or topical steroids will not be excluded

Any other clinical condition that, in the Investigator’s judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Recently Completed Trials

Specimen Acquisition for Viral Hepatitis

Now Enrolling – Volunteer for Trial »

DETAILS – Specimen Acquisition for Viral Hepatitis

The purpose of this research study is to obtain blood samples from adults, including pregnant woman. The samples will be used to demonstrate the safety and effectiveness of several hepatitis and other infectious disease laboratory tests. This study will have 1 visit to our office that will last approximately 1 hour.

Study Title:

Specimen Acquisition for Viral Hepatitis – Analytical Collection Study

About the Study:

This specimen acquisition study is being conducted to obtain blood samples from adult, pregnant and pediatric subjects that will be used to demonstrate the safety and effectiveness of several Roche hepatitis and/or other infectious disease assays (tests) over a period of several years. Clinical performance must be demonstrated for new assays to be approved by FDA for use by doctors. Samples will be collected from subjects according to the study protocol. Your blood sample will be kept frozen and used for testing in several new assays to create the data required for FDA test approval.

About 2300 adult, 200 pregnant and 200 pediatric subjects will take part in this study collected over approximately 6 months at several different study sites. Your study doctor will enroll a share of the total subjects listed.  This study site will only enroll subjects 18 years of age or older.

Qualifications:

You might qualify if you meet any of the criteria below:

  • Recipient of blood transfusions before July 1992
  • Recipient of solid organ transplant before July 1992
  • Recipients of clotting factors before 1987 (hemophiliacs)
  • Recipient of blood or organs from a donor that was HCV-positive
  • Received long-term (chronic) hemodialysis treatments
  • HIV infected or immunocompromised
  • Persons born in countries with high rates of hepatitis (Africa, Asia and Pacific Islands)
  • Family history of any hepatitis
  • Children born to hepatitis-positive mothers
  • Have abnormal liver tests or liver disease
  • Tattoo artists
  • Health care worker after needle stick or exposure involving HCV-positive blood
  • Morticians
  • Commercial sex workers
  • IV drug users (current and past)
  • Individuals sharing straw cocaine
  • Individuals with tattoo or body piercing that was performed by non-licensed or nonprofessional facilities
  • Individuals with history of incarceration
  • Multiple sex partners (two or more partners in the past 12 months)
  • Engaging in sex with partner(s) with history of hepatitis
  • Engaging in sex with HIV-infected partner(s)
  • Diagnosed with STD’s (chlamydia, gonorrhea, herpes, syphilis, etc.)
  • Male-on-male sex partner(s)
  • Engaging in sex with commercial sex workers

Become a Volunteer >

Dengue Human Infection Model (DHIM-1)

DETAILS – Dengue Human Infection Model (DHIM-1)

The purpose of this research study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work. This study will last 6 months and have approximately 21 visits to our office.

Study Title:

Phase One, Open Label, Assessment of a Dengue-1-Virus- Live Virus Human Challenge (DENV-1-LVHC) Virus Strain

About the Study:

Dengue is a disease caused by a virus. The virus is transmitted by a certain type of mosquito. When someone is bitten by a mosquito carrying dengue virus, he or she can get sick with a dengue infection. These infections can be very mild, with little or no symptoms, but may cause fevers, severe headache, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is referred to as an uncomplicated dengue infection. Occasionally the dengue infection can sometimes be severe and cause bleeding (hemorrhagic fever) and/or a sudden decrease of the blood pressure (shock). Severe reactions to natural dengue infections are uncommon and occur in less than 1% of all first infection cases. A severe infection from a natural dengue infection can cause death in some cases, mainly in children.

There are 4 types of dengue virus (1, 2, 3, and 4). Each one can make you sick. You usually cannot get sick from the same type twice. You can, however, get sick again if your second infection is with a different type of dengue. Second infections with a different type of dengue may have a more severe illness.

This study involves injection with a weakened form of dengue virus type 1 using 1 of 3 possible dosage strengths (low, medium, or high). There are no specific treatments (antibiotic or antiviral medications) available for dengue infection, but other supportive care will be provided, if required. Supportive care may include: medication for management of pain, fever reducing drugs (acetaminophen), the management of fluid loss through oral or intravenous hydration, close monitoring and clinical assessment by a physician, and fluid replacement if required. This supportive care follows the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines.

The types of mosquitoes that carry and transmit dengue virus are most frequently found in the tropical areas of the world (for example the Caribbean, South America, Asia, Puerto Rico, and Hawaii). They are present in some southeastern states in the United States (for example, Florida, Texas, Louisiana, Mississippi, Georgia). But except in rare instances, the mosquitoes present in the United States do not have the dengue virus. Therefore, there is a very low risk of contracting the disease in the continental United States compared to areas of the tropics where the disease is commonly present. While an outbreak of dengue occurred in Key West, Florida in 2009-2010, most dengue cases in US citizens are reported from people living in Puerto Rico, the US Virgin Islands, Samoa, and Guam or from travelers coming back from tropical areas. Dengue is now the leading cause of fever-causing illness in US travelers returning from the Caribbean, South America, and Asia.

Similar dengue studies have been done in humans before, using several different weakened dengue viruses. Some of these studies involve people who have been given investigational vaccinations against dengue fever prior to a weakened virus challenge, and some include people who were not vaccinated, but were just given the virus. Most subjects from these previous studies became ill with dengue fever, but some subjects did not become ill. The virus being used in this study is closely related to a version that has been used previously in 11 subjects. All of the previous subjects recovered within 30 days and showed no signs of long-term illness from participation in the study. We cannot guarantee this same recovery period or lack of long-term effects if you decide to participate in this study.

The purpose of this research study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work. For instance, in the future, we could give a subject a new dengue vaccine then give them the weakened dengue virus. If they do not develop dengue symptoms the vaccine may be working. If they do have dengue symptoms the vaccine may not be working. This weakened dengue virus could also be used to look at how the body?s immune system reacts to a dengue infection.

Giving a controlled infection to test vaccines or to look at the immune system is done for a number of diseases including malaria. It has been done with dengue viruses in the past. The weakened version of the dengue virus we are using in this study is newly produced, so now we need to carefully study the ways in which this new weakened dengue virus causes illness.

We also want to ensure that it can safely cause a mild form of dengue illness that can be used in future research.

While there have been other dengue infection trials, including with this type of dengue, this is the first study to use this particular weakened dengue virus in humans. We expect that subjects in this study will get a dengue infection, and this infection may require hospitalization.

We plan to enroll up to 27 subjects in the study. The subjects will be divided into 3 groups who will receive 1 of 3 different doses of the virus, beginning with the lowest dose. If safety issues are found with 1 of the doses, the higher doses will not be given.

Qualifications:

To be eligible for this study you must:

  • Be at least 18 years old and no more than 45 years old at time of consent
  • At least 75% correct on test of your understanding of the information in this informed consent form
  • For females only, non-pregnant or non-lactating
  • Not be planning to become pregnant or father a child for the duration of the study (6 months) and using contraceptive methods to prevent pregnancy
  • Not be using an intrauterine device or intrauterine system, including Mirena?, due to risk of heavy menstrual bleeding with these devices
  • Not have had heavy menstrual bleeding within the last 6 months
  • Have no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring
  • Be in good health, as determined by medical history and physical examination
  • Provide consent for release of medical history records
  • Not have abnormal lab results or significant physical findings prior to inoculation
  • Not have active Diabetes or active peptic ulcer disease
  • Not have chronic obstructive pulmonary disease or coronary artery disease
  • Not have a history of, or current, auto-immune disease
  • Not have a history of Guillain-Barr? syndrome
  • Not have been diagnosed with Bipolar Disorder or Schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study
  • Not have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus.
  • Have negative blood tests for seroconversion to dengue, West Nile, Yellow Fever, Japanese encephalitis and Zika virus
  • Have negative blood tests for HIV-1, Hepatitis B, and Hepatitis C
  • Not plan to be vaccinated for any flavivirus
  • Not have traveled within the past 4 weeks to an area where dengue infections occur naturally, and not have any planned travel during the study period (6 months)
  • Not plan to participate in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding inoculation, during the study period, or in the 6 months following inoculation
  • Not have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination within 4 weeks following inoculation
  • Not have had medicines or therapies that suppress your immune system
  • Not currently be taking anti-coagulant medication, non-steroidal anti-inflammatory drugs
  • Not currently taking Methadone or Suboxone
  • Not have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish, Fetal Bovine Serum, L-Glutamine, Neomycin, and Streptomycin
  • Not have a history of chronic migraine headaches
  • Not have a recent blood donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection
  • Not planning to receive blood products or antibodies within 56 days of inoculation or during the study period (6 months)
  • Have negative urine screen for cocaine, amphetamines, or opiates
  • Not have beliefs that prohibit the administration of blood products or transfusions
  • Be able to read, sign, and date this informed consent

Effect of Antimalarial Drugs to the Rabies Vaccine

DETAILS – Effect of Antimalarial Drugs to the Rabies Vaccine

The purpose of this study is to look at the effect of taking medications that prevent malaria (antimalarials) on the ability of a person?s body to develop the natural immune response to a rabies vaccine. It is thought that taking antimalarials may interfere with this natural reaction and the person may not develop the response necessary to prevent rabies after they have been exposed to it. This study will last 3 months and have 8-11 visits in our office.

Study Title:

Effect of Antimalarial Drugs on the Immune Response to Rabies Vaccine for Post-Exposure Prophylaxis. A Randomized, Open Label Trial in Healthy US Adults Age 18-60 Years

About the Study:

The purpose of this study is to look at the effect of taking medications that prevent malaria (antimalarials) on the ability of a person?s body to develop the natural immune response to a rabies vaccine. It is thought that taking antimalarials may interfere with this natural reaction and the person may not develop the response necessary to prevent rabies after they have been exposed to it.

This is important to the US Department of Defense, the current funders of this study; because they deploy soldiers to areas that require them to take antimalarials and they have a high chance of being exposed to rabies.

The rabies vaccine used in this study is RabAvert?. This rabies vaccine is approved by the US Food and Drug Administration (FDA) and is used in this area for pre-exposure immunization in people at risk of contact with rabid animals and for post exposure prevention in people who have been bitten by a rabid or suspected rabid animal.?

The antimalarial drugs used in this study are Chloroquine, Malarone and Doxycycline. These drugs are all approved by the FDA for the prevention and treatment of malaria.

We plan to enroll 100 subjects in the study, being conducted at Upstate Medical University.

Qualifications:

Subjects must meet all of the following criteria in order to be eligible for trial enrollment:

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female, aged ? 18 to ? 60 years on day of inclusion
  • In good general health based on medical history and physical exam

A subject fulfilling any of the following criteria will be excluded from trial enrollment:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination.)
  • Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
  • Previous history of receiving the rabies vaccine.
  • Previous history of receiving rabies immune globulin.
  • Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not exclusion criteria.
  • Use of any immunosuppressive drug at the time of the study or 30 days previously. Topical steroids will not be considered an immunosuppressive drug and their use will not be considered an exclusion criteria.
  • Any immunosuppressive disorder, such as HIV infection, common variable immunodeficiency, active cancers or chemotherapy.
  • History of renal insufficiency or requiring dialysis.
  • Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
  • Previous adverse reaction to any of the antimalarial drugs used in this study.

HIV Treatment for Treatment-Experienced Adults

DETAILS – HIV Treatment for Treatment-Experienced Adults

This study is being conducted to determine if the study product, PRO 140, is safe and if it works to suppress viral load in HIV-1 patients in combination with FDA approved antiretroviral regimens. This study will last for approximately 9 months depending on your response to the treatment and have approximately 28 visits to our office.

Study Title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-Arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects.

About the Study:

This study is being conducted to determine if the study product, PRO 140, is safe and if it works to suppress viral load in HIV-1 patients in combination with FDA approved antiretroviral regimens.

The safety and effectiveness of PRO 140 has been previously evaluated in 174 people in previous studies. The product you will be using is an investigational drug. An investigational drug is one not approved by the U.S. Food and Drug Administration (FDA). The results of these studies will be used to design future studies to try to better understand how to design and implement treatment regimens that will be most successful in treating HIV-1 infection.

About 50 subjects will enroll in the study within the USA.?

Qualifications:

Potential subjects are required to meet all of the following criteria for enrollment into the study.

  • Males and females, age ? 18 years
  • Exclusive CCR5-tropic virus at Screening Visit as determined by Monogram Biosciences Trofile?Assay
  • Have a history of at least 3 months on current antiretroviral regimen
  • Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within three drug classes

OR

  • Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within two drug classes and have limited treatment option.
  • Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
  • Plasma HIV-1 RNA ? 400 copies/mL at Screening Visit as determined by Human Immunodeficiency
  • Virus 1 (HIV-1) Quantitative, RNA (Roche Taqman? Real-Time PCR) and documented detectable viral load (HIV-1 RNA >50 copies/ml) within the last 3 months prior to Screening Visit.
  • Laboratory values at Screening that meet the protocol criteria.
  • Clinically normal resting 12-lead ECG at Screening Visit
  • Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception during the course of the study.
  • Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
  • Willing and able to participate in all aspects of the study

Potential subjects meeting any of the following criteria will be excluded from enrollment.

  • Documented CXCR4-tropic virus or Dual/Mixed tropic (R5X4) virus as determined by HIV-1 tropism assay
  • Patients with no viable treatment options
  • Any active infection or malignancy requiring acute therapy
  • Laboratory test values of ? grade 3 DAIDS laboratory abnormality with the exception of the absolute
  • CD4+ count criterion of < 200/mm3
  • Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  • Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  • Any vaccination within 2 weeks prior to the first study dose.
  • Subjects weighing < 35kg
  • History of anaphylaxis to oral or parenteral drugs
  • History of Bleeding Disorder or patients on anti-coagulant therapy
  • Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  • Any known allergy or antibodies to the study drug or excipients
  • Treatment with any of the following:
    • Radiation or cytotoxic chemotherapy with 30 days prior to the Screening Visit
    • Immunosuppressants within 60 days prior to the Screening Visit
    • Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the Screening Visit
  • Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception, subjects on inhaled, nasal, or topical steroids will not be excluded.
  • Any other clinical condition that, in the Investigator’s judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Sample Collection for Evaluation of a Hepatitis A Assay

DETAILS – Sample Collection for Evaluation of a Hepatitis A Assay

The purpose of this study is to aid in the development of a new diagnostic test for the Hepatitis A Virus (HAV). Blood samples are needed to test the ability of the Elecsys? Anti-HAV II Assay to reliably detect the presence of the hepatitis A virus. This study will have 1 visit to our office that will last approximately 1 hour.

Study Title:

Sample Acquisition/Collection for CIM RD002782 Performance Evaluation: Elecsys? Anti-HAV II on the cobas e 601 Immunoassay Analyzer

About the Study:

The purpose of this study is to aid in the development of a new diagnostic test for the hepatitis A virus (HAV). Hepatitis A is a liver disease caused by the hepatitis A virus. The virus is primarily spread when an uninfected (and unvaccinated) person ingests food or water that is contaminated with the feces of an infected person. The disease is closely associated with unsafe water or food, inadequate sanitation and poor personal hygiene.

Approximately 800 subjects will be recruited to participate in a clinical study. A blood sample is needed to test the ability of the Elecsys? Anti-HAV II Assay to reliably detect the presence of the hepatitis A virus. The test is intended as an aid in the laboratory diagnosis of individuals with acute or past hepatitis A virus infection, or as an aid to determine the presence of an antibody response to HAV in vaccine recipients. To this end the assay has to be tested in individuals that are apparently healthy with an unknown risk for hepatitis A infection.

The study will take place at a minimum of two sites located in geographically diverse sections of the US. No testing device is used in this study. During this study you will provide a blood sample together with specific medical information. The duration of participation in this study is expected to be approximately 20 minutes or less.

Qualifications:

Potential subjects are required to meet all of the following criteria for enrollment into the study.

  • Subjects must be asymptomatic for hepatitis including jaundice, nausea, fatigue, abdominal pain in the last 6 months.
  • Subject age is ?22 years of age
  • Following data must be available: age, gender, race, ethnicity
  • Total serum specimen volume after processing is > 1.0 mL
  • Subject must be able to read/understand and sign the informed consent or have a legal guardian who is willing to give written consent
  • Subjects must successfully complete a general health questionnaire

Potential subjects meeting any of the following criteria will be excluded from enrollment.

  • Subject with increased risk for hepatitis infection according to CDC based on behavior, sexual risk, and/or occupation

The Role of Antibodies in Long-Term Non-Progressing HIV

DETAILS – The Role of Antibodies in Long-Term Non-Progressing HIV

This research is being done to determine if people with HIV who have certain antibody responses in their blood are more likely to maintain adequate CD4 counts off of therapy. We want to learn if the presence of certain antibodies in the blood are more common in individuals infected with HIV who do not show progression of their disease (indicated by maintenance of adequate CD4 levels off therapy). This study will have 1 visit that will take approximately 15 minutes.

Study Title:

The role of non-broadly neutralizing antibodies targeting gp41 structural epitopes in long term non-progression of HIV infection

About the Study:

This research is being done to determine if people with HIV who have certain antibody responses in their blood are more likely to maintain adequate CD4 counts off of therapy. We want to learn if the presence of certain antibodies in the blood are more common in individuals infected with HIV who do not show progression of their disease (indicated by maintenance of adequate CD4 levels off therapy).

We expect a total of about 120 people in this research study from 5 locations within New York, with approximately 79 of those people coming from this site in Syracuse, NY.

Qualifications:

  • Known HIV infection falling into one of three groups:
    • LTNP? CD4 count >350 for a minimum of 7 years off therapy
    • Maintain on therapy- On therapy and maintaining adequate CD4 counts
    • Progressors ? CD4 counts <350
    • ? 18 years of age

?Male or female with the ability to provide informed consent