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

NCT03878121 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-21

No results posted yet for this 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

  • Healthy Volunteer

Interventions

BIOLOGICAL

Ad4-Env145NFL

10\^8 vp doses of Ad4-Env145NFL formulated as a liquid for intranasal administration.

BIOLOGICAL

Ad4-Env150KN

10\^8 vp doses of Ad4-Env150KN formulated as a liquid for intranasal administration.

BIOLOGICAL

VRC-HIVRGP096-00-VP (Trimer 4571) with alum

500-mcg dose of protein boost vaccine formulated for intramuscular administration.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878121 on ClinicalTrials.gov