OUTLINE OF PROTOCOL 002B

 

A PHASE I RANDOMIZED TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF VACCINIA-HIV ENVELOPE RECOMBINANT VACCINE (HIVAC-1e) IN COMBINATION WITH SOLUBLE RECOMBINANT ENVELOPE VACCINE (VAXSYN)

 

Subjects: 13 healthy, HIV-1 uninfected adult volunteers who have previously received two doses of HIVAC-1e (n=12) or DryVax (n=1) and two doses of rgp160 (VaxSyn) 160 µg.

Schema: In this protocol, each individual received a single additional injection of VaxSyn (160 µg) at 12-20 months following their last boost, and an additional vaccination with HIVAC-le >9 months after the final VaxSyn injection.

 

IMMUNIZATIONS AND FOLLOW-UP COMPLETED

 

Product Description: HIVAC-1e: Vaccinia vector containing HIV-1 LAI rgp160 [Bristol Myers-Squibb/Oncogen]
VaxSyn: Baculovirus-derived HIV-1 LAI rgp160 in alum [MicroGeneSys]

Time Period: First volunteer entered on 03/28/91and the last was enrolled on 06/21/91; follow-up >18 months.

Clinical Site: University of Washington

Study Chair: Lawrence Corey, University of Washington

 

STUDY GOALS

To evaluate additional boosting in prior participants in the initial trial of HIVAC-1e.

 

REFERENCE

Cooney EL, McElrath MJ, Corey L, Hu SL, Collier AC, Arditti D, Hoffman M, Coombs RW, Smith GE, Greenberg PD. Enhanced immunity to human immunodeficiency virus (HIV) envelope elicited by a combined vaccine regimen consisting of priming with a vaccinia recombinant expressing HIV envelope and boosting with gp160 protein. Proc Natl Acad Sci USA. 1993;90:1882-1886.