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Virus Therapy
HIV Vaccines Safety and Response in Healthy Volunteers
Phase 1
Recruiting
Led By Mark Connors, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
-- male partner has previously undergone a vasectomy for which there is documentation.
- No history of hypogammaglobulinemia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights
Study Summary
This trial is testing the safety of three new HIV vaccines. Two of the vaccines are carried by live adenoviruses, which can cause cold symptoms or an eye infection. The trial will test if the vaccines help fight HIV, and if the adenoviruses are contagious.
Who is the study for?
Healthy adults aged 18-49 (vaccinees) and their close contacts aged 18-65 can join this trial. Participants must test negative for HIV, not be pregnant or breastfeeding, agree to use contraception, and have no history of immune or lung function issues. They should also commit to the full duration of the study.Check my eligibility
What is being tested?
The trial is testing three new HIV vaccines: two are adenovirus-based nasal sprays and one is a booster shot with alum given by needle. The goal is to assess safety, immune response, and whether the live viruses used in vaccines spread.See study design
What are the potential side effects?
Potential side effects may include typical cold symptoms due to adenoviruses such as sore throat or runny nose; reactions at the injection site from the booster; fatigue; headache; muscle pain; fever after vaccination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My male partner has had a vasectomy, and we have the documents to prove it.
Select...
I have never had low levels of antibodies.
Select...
I use condoms with spermicide for birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ongoing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and immunogenicity
Trial Design
4Treatment groups
Experimental Treatment
Group I: B2 (exploratory)Experimental Treatment2 Interventions
Previously vaccinated; Ad4-Env145NFL at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months.
Group II: B1 (exploratory)Experimental Treatment2 Interventions
Previously vaccinated; Ad4-Env150KN at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months.
Group III: A2Experimental Treatment2 Interventions
Ad4-Env145NFL at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months.
Group IV: A1Experimental Treatment2 Interventions
Ad4-Env150KN at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,832 Total Patients Enrolled
Mark Connors, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
5 Previous Clinical Trials
1,247 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking steroids or other immune-suppressing drugs.You cannot receive any other experimental or HIV vaccines during the study.I am using birth control pills, Norplant, or Depo-Provera without any interfering medications.I have received the Merck Ad5-based HIV vaccine before.My male partner has had a vasectomy, and we have the documents to prove it.None of my close contacts refuse to participate in this study.My kidney function is within the required range.I am between 18 and 49 years old and getting the vaccine, or I am a close contact aged 18 to 65.I have no past diseases or treatments that affected my immune or lung function.I have had radiation or chemotherapy for cancer.I have a history of diabetes.I haven't had a serious infection or signs of weak immunity in the last 6 months.I am not breastfeeding or planning to become pregnant soon.I am under 18 years old.I have a long-term lung condition.I have had Guillain-Barre syndrome in the past.I have an active hepatitis B or C infection confirmed by tests.I am a woman or a man in close contact with someone who meets the vaccine criteria.I cannot have children due to menopause, surgery, or medical condition.I agree to use effective birth control or practice abstinence for 28 days after each vaccination.My blood counts meet the trial's requirements.My liver is functioning properly.My metabolism is within the study's required range.My hormone levels are relevant to my condition.I have never had low levels of antibodies.I agree not to donate sperm for 28 days after each vaccine dose.I have had cancer before, but it was either skin cancer treated with the intent to cure, or early-stage cervical cancer.I have a long-term lung condition like asthma or emphysema.I do not have a psychiatric condition that affects my ability to follow treatment plans.I am over 65 years old.I am responsible for caring for a child under 18 or an elderly person.I have received specific treatments.I haven't taken antiviral medications in the last 30 days.I haven't taken any research drugs or agents that could affect the study vaccine in the last 30 days.I am in good health with no major medical issues.I use condoms with spermicide for birth control.You agree to let us keep your samples for future research.You agree to take steps to prevent the spread of adenovirus in your community.
Research Study Groups:
This trial has the following groups:- Group 1: A1
- Group 2: A2
- Group 3: B1 (exploratory)
- Group 4: B2 (exploratory)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Ad4-Env150KN a safe treatment for those under care?
"Due to the limited data surrounding Ad4-Env150KN, our evaluation at Power has assigned it a safety rating of 1. This is in part due to this being Phase 1 trial and lack of evidence for efficacy or safety."
Answered by AI
To what extent is this research project involving human participants?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently in search of participants after being posted on April 17th 2019 and last updated July 6th 2022. The study seeks 300 patients from a single site."
Answered by AI
Who can partake in this medical experiment?
"This clinical trial is seeking 300 participants between the ages of 18-65 who are deemed to be healthy subjects (hs). In addition, patients must meet additional criteria such as: a negative FDA-approved HIV test, assessed low risk for HIV infection by agreeing to discuss risks and taking part in counselling sessions, passing a beta-HCG pregnancy test if female and presumed reproductive age, using male/female condoms with spermicide or being heterosexually inactive 21 days prior to each vaccination through 28 days following each one."
Answered by AI
Is this experimentation currently enrolling participants?
"Affirmative. Clinicaltrials.gov states that the trial is presently enrolling participants, with the posting date of April 17th 2019 and a most recent update on July 6th 2022. The research aims to recruit 300 people from 1 site."
Answered by AI
Is the age range of participants in this experiment restricted to those over 85?
"As detailed in the eligibility requirements, this study is restricted to individuals between 18 and 65 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- National Institutes of Health Clinical Center: < 48 hours
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