NCT00001136

A Study of the Effectiveness of an HIV Vaccine (ALVAC vCP205) to Boost Immune Functions in HIV-Negative Volunteers Who Have Already Received an HIV Vaccine

A Multi-Centered Phase 1 Trial to Evaluate the Memory Responses to a Single Boosting Vaccination With ALVAC-HIV vCP205 in Volunteers Who Have Previously Received Poxvirus-Based Vaccines

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune system responds to this vaccine. Vaccines are given to people to try to resist infection or prevent disease. There are a number of different HIV vaccines that are currently being tested. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the immune system responds to it.

Detailed description

Vaccines may provide a route of therapy against HIV-1 infections by boosting the immune system responses. An artificially constructed HIV-1 vaccine (NYCBH), using vaccinia virus as its vector, has the advantage of conferring both cellular and humoral immune responses that are long-lived. Studies have shown that a second artificially constructed vector vaccine, HIV-1 canarypox (vCP205), also increases CD8+ cytotoxic T lymphocyte (CTL) activity, a cell-mediated immune response. Yet, immune responses are not boosted in volunteers previously vaccinated with vaccinia-based HIV-1 vaccines when a second vaccination with the same vaccine is given. One theory for vaccinia vaccine's failure is that immunologic barriers by antibodies to the vector itself may be responsible. This study examines the effectiveness of boosting the immune responses following vCP205 vaccination in the following: 1) volunteers who were previously immunized with vCP205 vaccine who may or may not have shown increased immune responses following the first immunization, and 2) volunteers who were previously immunized with NYCBH vaccine. Upon study entry volunteers receive one injection of ALVAC-HIV vCP205. Temperature and symptoms should be recorded by the volunteer each day for 2 days and reported to the clinic staff. Volunteers will have seven clinic visits for drawing blood, collecting urine specimens, and performing clinical evaluations. At Month 3 HIV testing will be done. Volunteers will be followed for 3 months, with a passive follow-up call at the end of a year and once or twice a year for the next 5 years. Counseling on avoidance of HIV infection and pregnancy will be done.

Conditions

• HIV Infections
• HIV Seronegativity

Interventions

Type	Name	Description
BIOLOGICAL	ALVAC-HIV MN120TMG (vCP205)

Timeline

• Completion: 2001-05-01
• First posted: 2001-08-31
• Last updated: 2021-11-01

Locations

6 sites across 1 country: United States