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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

NCT00000746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-11-04

No results posted yet for this study

Summary

Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters.

Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.

In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

rgp120/HIV-1 SF-2

BIOLOGICAL

Env 2-3

BIOLOGICAL

HIVAC-1e

BIOLOGICAL

gp160 Vaccine (MicroGeneSys)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Corey L

Study Design

Purpose
PREVENTION

Eligibility

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

Timeline & Regulatory

Completion
1994-07-31

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 NCT00000746 on ClinicalTrials.gov