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Study to Evaluate the Safety and Immunogenicity of an Oral HIV Vaccine in Healthy, HIV-uninfected Adults

NCT02771730 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-18

No results posted yet for this study

Summary

The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.

Conditions

  • Healthy Volunteer
  • HIV Vaccine

Interventions

BIOLOGICAL

Ad4-mgag

A live replication-competent Adenovirus type-4 vector encoding a mosaic HIV Gag antigen, delivered orally by enteric-coated capsules.

BIOLOGICAL

Ad4-EnvC150

A live replication-competent Adenovirus type-4 vector encoding an HIV clade C Env protein (gp150 1086.C), delivered orally by enteric-coated capsules.

OTHER

Placebo Comparator

Oral sucrose capsules

BIOLOGICAL

AIDSVAX B/E

300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Sean Bennett, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-02-28
Completion
2017-02-28

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 NCT02771730 on ClinicalTrials.gov