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A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals

NCT00001026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-11-04

No results posted yet for this study

Summary

Primary: To determine whether combination vaccination, i.e., priming with a vaccinia recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant subunit envelope protein (gp160 or gp120), provides enhanced immunogenicity compared to subunit vaccination with the individual recombinant envelope proteins only. To compare the relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as boosters following recombinant HIV-vaccinia priming. To evaluate the relative immunogenicity of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost.

Secondary: To examine the safety of administering the individual subunit vaccines in combination with the HIV envelope vaccinia recombinant, and to extend the population to whom these proteins have been administered.

Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans. This study will further examine the combination vaccine approach and define an optimal prime-boost strategy.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

gp160 Vaccine (Immuno-AG)

BIOLOGICAL

rgp120/HIV-1IIIB

BIOLOGICAL

rgp120/HIV-1MN

BIOLOGICAL

rgp120/HIV-1 SF-2

BIOLOGICAL

HIVAC-1e

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
PREVENTION
Masking
DOUBLE

Eligibility

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

Timeline & Regulatory

Completion
1994-12-31

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 NCT00001026 on ClinicalTrials.gov