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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.
Must not have
- Taking any glucocorticoids or other immunosuppressive medications.
- Prior receipt of the Merck Ad5-based HIV vaccine.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My male partner has had a vasectomy, and we have the documents to prove it.
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I have never had low levels of antibodies.
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I use condoms with spermicide for birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking steroids or other immune-suppressing drugs.
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I have received the Merck Ad5-based HIV vaccine before.
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I have no past diseases or treatments that affected my immune or lung function.
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I have had radiation or chemotherapy for cancer.
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I have a history of diabetes.
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I am under 18 years old.
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I have a long-term lung condition.
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I have had Guillain-Barre syndrome in the past.
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I have an active hepatitis B or C infection confirmed by tests.
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I do not have a psychiatric condition that affects my ability to follow treatment plans.
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I am over 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and immunogenicity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,336 Previous Clinical Trials
5,392,464 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

Ad4-Env145NFL (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03878121 — Phase 1
Healthy Subjects Research Study Groups: A1, A2, B1 (exploratory), B2 (exploratory)
Healthy Subjects Clinical Trial 2023: Ad4-Env145NFL Highlights & Side Effects. Trial Name: NCT03878121 — Phase 1
Ad4-Env145NFL (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03878121 — Phase 1
~13 spots leftby Apr 2025
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