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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers

NCT00001072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-11-04

No results posted yet for this study

Summary

To evaluate, in HIV-negative volunteers, the safety and immunogenicity of ALVAC-HIV MN120TMGNP (vCP300) followed by or combined with boosting using rgp120/HIV-1SF2. To compare ALVAC-HIV vCP300 with ALVAC-RG rabies glycoprotein (vCP65) as a control. To evaluate an accelerated immunization schedule at 0, 1, 3, and 6 months versus 0, 1, 6, and 9 months.

The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

ALVAC-HIV MN120TMGNP (vCP300)

BIOLOGICAL

ALVAC-RG Rabies Glycoprotein (vCP65)

BIOLOGICAL

rgp120/HIV-1 SF-2

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Keefer M

  • Evans T

Study Design

Purpose
PREVENTION
Masking
DOUBLE

Eligibility

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

Timeline & Regulatory

Completion
1999-01-31

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 NCT00001072 on ClinicalTrials.gov