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A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine

NCT00000835 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-10-29

No results posted yet for this study

Summary

The purpose of this trial is to determine the safety and immunogenicity of an HIV-1 pseudovirion vaccine given at one antigen dose alone and in combination with each of two different adjuvants using two immunization schedules.

The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles. The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins. The pseudovirion vaccine has been tested in preclinical trials in mice, guinea pigs, rabbits, and nonhuman primates with good safety and immunogenicity profile.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Gorse G

Eligibility

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

Timeline & Regulatory

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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 NCT00000835 on ClinicalTrials.gov