Study Details

Protocol Status:
Study Purpose:

To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV (vCP205) in HIV-1 uninfected adults

Study Design:

The study is a randomized, placebo-controlled, double-blind, 3-arm trial

Study Population:

Forty healthy, HIV-1 uninfected, adult volunteers 18-40 years of age without identifiable high risk behavior for HIV infection

Study Size:

Forty HIV-1 uninfected adults

Study Duration:

Enrollment/immunization began February 8, 1999 and was completed in August 1999 with 32 male and 8 female Ugandan participants. The vaccination phase of the study was completed in Feburary 2000 when the last volunteer received his final vaccination. Follow-up for all participants will continue through August 2001

Treatment Regimen:

At 20 - 24 weeks, women randomized to receive antibiotics will receive metronidazole 250 mg three times a day (TID) and erythromycin 250 mg TID orally for 7 days. Women randomized to the control group will receive identically appearing placebos. With the onset of contractions and/or premature rupture of membranes (PROM), study participants will initiate a second oral course of antibiotics consisting of metronidazole 250 mg and ampicillin 500 mg or placebo every 4 hours, continuing after delivery TID until the course is completed. All HIV-infected women and their neonates will be offered the HIVNET 012 nevirapine (NVP) regimen. If the mother accepts the nevirapine for herself and her baby, she will be given one oral dose of 200 mg NVP to be taken at onset of labor, and her baby will receive one oral dose of 2mg/kg NVP suspension at 72 hours post-birth or discharge, whichever occurs earlier. If the mother refuses nevirapine or is uninfected, she will be offered a matched placebo at the 26-30 week visit to preserve participant confidentiality.

Primary Objectives:

To evaluate the safety of ALVAC-HIV when given to healthy, HIV-1 uninfected adult volunteers.
To evaluate the antibody and cellular immune responses to the candidate HIV-vaccine by determining whether immunization induces the following:
CTL responses against gag, env and protease proteins from clade A, B and D HIV-1 isolates
neutralizing antibodies to HIV-1 MN and clade A, B and D HIV-1 isolates

Study Sites List