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NCT03878121 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
A Phase 1 study of Healthy Volunteer, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT03878121 is a Phase 1 study of Healthy Volunteer that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants, above the 199-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (51% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03878121, a Phase 1 study of Healthy Volunteer, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 199-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (51% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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.
NCT03878121 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
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.
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).
Who is sponsoring clinical trial NCT03878121?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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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