CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
ALVAC-HIV gp160MN (vCP125) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000813
NCT00000813Phase 1Completed

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 4, 2021

In Brief

A Phase 1 clinical trial evaluating ALVAC-HIV gp160MN (vCP125), ALVAC-RG Rabies Glycoprotein (vCP65), and 1 other intervention for HIV Infections. Completed, across 1 site.

Detailed Summary

Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected adult volunteers. Part B: To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal immunogenicity. Amendment: 12/22/93: To determine whether ALVAC gp160 MN in combination with SF-2 rgp120 subunit protein is capable of generating humoral and cellular immune responses of greater intensity and longer duration than either vaccine administered alone. A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular responses have been augmented by the combination of two recombinant vaccines, especially in vaccinia naive individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States

Timeline

Phase 1CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Study CompletionJun 1, 1995
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

ALVAC-HIV gp160MN (vCP125)biological

ALVAC-RG Rabies Glycoprotein (vCP65)biological

rgp120/HIV-1 SF-2biological