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Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

NCT00111605 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-10-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a vaccine. This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

HIV-1 gag DNA

A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid

BIOLOGICAL

HIV-1 gag DNA plus IL-12 DNA adjuvant

Injection IL-12 DNA adjuvant intramuscularly into the deltoid

BIOLOGICAL

CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)

A 1 mL intramuscular injection in the deltoid

BIOLOGICAL

Sodium chloride injection (0.9%)

All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid. Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Spyros Kalams, MD · Vanderbilt University

  • Scott Parker, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Completion
2008-05-31

Countries

  • United States
  • Thailand

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 NCT00111605 on ClinicalTrials.gov