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Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
NCT03878121 · View on ClinicalTrials.gov ↗
Study Summary
Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious. Objectives: To test the safety and effects of three new HIV vaccines. Eligibility: Healthy adults 18-49 years old (vaccinees) Their household and intimate contacts 18-65 years old Design: Vaccinees will be screened with: Physical exam Medical history Blood and urine tests Questions about HIV risk Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study. Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18-65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam. All applicable participants will have a pregnancy test at every visit. Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get: 1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits The booster vaccine by needle in an arm at 1 visit Nasal swabs taken at some visits Vaccinees will note their temperature and symptoms for at least 1-4 weeks after each vaccine. Vaccinees may choose to have: Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm. Small pieces of the tonsil removed Sponsoring Institute: National Institute of Allergy and Infectious Diseases ...
Conditions Studied
Interventions
- BIOLOGICAL Ad4-Env145NFL
- BIOLOGICAL Ad4-Env150KN
- BIOLOGICAL VRC-HIVRGP096-00-VP (Trimer 4571) with alum
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2026-10-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03878121
The ClinicalTrials.gov registry entry for NCT03878121 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions — of which Ad4-Env145NFL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03878121 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03878121 about?
NCT03878121 is a clinical study titled "Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers". Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviru...
What is the current status of trial NCT03878121?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2019-04-17. Estimated completion is 2026-10-15.
What conditions does trial NCT03878121 study?
This clinical trial studies the following conditions: Healthy Volunteer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03878121?
The interventions under investigation include: Ad4-Env145NFL (BIOLOGICAL), Ad4-Env150KN (BIOLOGICAL), VRC-HIVRGP096-00-VP (Trimer 4571) with alum (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03878121?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03878121 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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