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Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors

This study is testing the safety and immune response (immunogenicity) of three potential HIV vaccines in healthy volunteers. Two vaccines, Ad4-Env145NFL and Ad4-Env150KN, are given as a nasal spray. A third vaccine, VRC-HIVRGP096-00-VP (Trimer 4571) with alum, is given as a shot into the muscle. Researchers want to see if these vaccines are safe and if they help your body create defenses against HIV. They also want to understand if the adenovirus carriers (which can cause cold-like symptoms) are contagious. You may be able to join if you are a healthy adult between 18 and 49 years old, or a household or intimate contact between 18 and 65 years old, and have tested negative for HIV.

Study design
This is a Phase 1 interventional study involving 300 planned participants. It is designed to evaluate the safety and immune responses to the vaccines.
What's involved
Vaccinees will receive nasal spray vaccines at months 0 and 2, and an intramuscular booster shot at month 6. You will have follow-up visits and tests for the duration of the study, including blood and urine tests.
Compensation
Not stated in the trial record.
Follow-up
Specimens to evaluate immune response will be taken at baseline and at specified time points through month 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03878121

Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers

Recruiting
PHASE1Ages 18–65InterventionalPrevention
National Institute of Allergy and Infectious Diseases (NIAID)
~300 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Ad4-Env145NFLAd4-Env150KNVRC-HIVRGP096-00-VP (Trimer 4571) with alum

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and immunogenicity
Measured over ongoing

Conditions

Healthy Volunteer

Explore related trials

Healthy VolunteerBlocking Antibody

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Mark Connors, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Mark Connors, M.D.
[email protected]
(301) 496-8057
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The female vaccinee has no reproductive potential because of menopause (1 year without menses) or because of a hysterectomy, bilateral oophorectomy, medically-documented ovarian failure, or tubal ligation.
The female vaccinee and her male intimate contact(s) agree to be heterosexually inactive or consistently practice contraception at least 21 days prior to each vaccination through 21 days following each vaccination. Acceptable methods of contraception include any of
condoms, male or female, with a spermicide.
diaphragm or cervical cap with spermicide.
contraceptive pills, Norplant, or Depo-Provera (and is not on any medications that would interfere with the effectiveness of these contraceptive agents).
male partner has previously undergone a vasectomy for which there is documentation.
intrauterine device. 5. Male vaccinees and female intimate contacts must agree to consistently practice abstinence or effective birth control (described above) and for 21 days following each vaccination.
Hematologic:
White blood cell count and lymphocyte count within 25% of both the lower limit and upper limit of normal for the NIH CC
Platelet count of least 150,000/mm\^3.
Hemoglobin count within 10% of both the lower limit and upper limit of normal for the NIH CC
Renal: Blood urea nitrogen (BUN) \<23 mg/dL; creatinine within normal limits for the NIH CC
Hepatic: Serum direct bilirubin within normal limits for the NIH CC
Metabolic: Alanine aminotransferase (ALT) \<2 times upper limit of normal range for the NIH CC
Additional laboratory criteria:
Immunologic: No history of hypogammaglobulinemia.
Serologic: Ad4 neutralizing antibody 80% inhibitory dilution \<1:100. (This criterion does not apply to participants in Arm B.) 5. Willing to follow precautions for preventing the spread of adenovirus in the community. 6. Males must agree not to donate sperm for 21 days following each study vaccination.

Exclusion

Antiviral medications within 30 days prior to vaccination.
Blood products within 120 days prior to HIV screening.
Immunoglobulin within 60 days prior to HIV screening.
Investigational research drugs or any other investigational agent that in the judgement of the Principal Investigator might interact with the study vaccine within 30 days prior to initial study vaccine administration.
Allergy treatment with antigen injections within 30 days of study vaccine administration. 6. Active hepatitis B or C infection (i.e., hepatitis B or C positive serology with the presence of virus antigen or DNA). Ongoing viral replication will be confirmed by a hepatitis B antigen test or hepatitis C viral load. 7. History of Guillain-Barre syndrome. 8. Indeterminate HIV Western blot test. 9. Prior receipt of the Merck Ad5-based HIV vaccine.

What this trial measures

  • Safety and immunogenicityongoing

    Laboratory results and Adverse Events