Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT01549470
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Currently, no vaccine prevents HIV infection. This study will test the safety and immune responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.

Detailed Description

The global HIV/AIDS epidemic continues to increase at unacceptably high levels, and there is not yet an effective prevention method for HIV infection. This study will test the safety and immune responses of a preventive HIV vaccine, VRC-HIVDNA009-00-VP, which is a multiclade HIV-1 DNA plasmid vaccine.

This study will seek to enroll 30 participants, randomly assigning 15 participants each to the study vaccine arm and the placebo vaccine arm. Three doses of the vaccine will be given by intramuscular (IM) injection using the Biojector 2000 needle-free injection management system: the first dose at Day 0 (entry), second dose at Day 28 (within 7 days before or after Day 28), and third dose at Day 56 (within 7 days before or after Day 56). Participants will attend two screening visits and visits at Days 0 (entry), 2, 14, 28, 30, 42, 56, 58, 70, 84, 168, 252, and 336. At most visits, participants will give a medical history and undergo a physical exam, blood draw, and urine collection. For women, a pregnancy test will be given at each study injection visit. Participants also will be instructed to maintain a diary of local and systemic reactions for 7 days after each injection. They also will be provided with a ruler to measure erythema, induration, or other observable reactions and a thermometer to record temperature on a daily basis.

Study Timeline

• Study Completion: 2006-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local reactogenicity signs and symptoms	Measured through Week 48 visit
Systemic reactogenicity signs and symptoms	Measured through Week 48 visit
Laboratory measures of safety	Measured through Week 48 visit
HIV-specific cellular immune responses	Measured through Week 48 visit	As measured by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot) and intracellular cytokine assay using frozen peripheral blood mononuclear cells (PBMCs) and overlapping peptide pools representing the immunogens.
All adverse experiences and serious adverse experiences	Measured through Week 48 visit

Secondary Outcome Measures

Name	Time	Method
Lymphoproliferative responses	Measured through Week 48 visit
Cytotoxic T lymphocyte (CTL) measured by chromium release assays	Measured through Week 48 visit
Antibody immune responses as measured by enzyme-linked immunosorbent assay (ELISA)	Measured through Week 48 visit
Neutralizing antibody assays	Measured through Day 70

Trial Locations

Locations (1)

Makerere University Walter Reed Project (MUWRP); 🇺🇬 Kampala, Uganda