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A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

NCT00000757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-04

No results posted yet for this study

Summary

To evaluate the safety and immune response to 160 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation.

Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

gp160 Vaccine (MicroGeneSys)

Sponsors & Collaborators

  • Protein Sciences Corporation

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Belshe R

  • Clements ML

  • Couch R

  • Dolin R

  • Levine M

  • Wright P

Study Design

Purpose
PREVENTION
Masking
DOUBLE

Eligibility

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

Timeline & Regulatory

Completion
1992-10-31

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 NCT00000757 on ClinicalTrials.gov