OUTLINE OF PROTOCOL 024

 

A RANDOMIZED, PLACEBO CONTROLLED, DOUBLE-BLINDED PHASE I SAFETY AND IMMUNOGENICITY TRIAL OF RECOMBINANT ENVELOPE PROTEIN, HIV-1 SF-2 RGP120 (BIOCINE), COMBINED WITH MF59

 

Subjects: Healthy, HIV-1 uninfected adult volunteers 18-60 years of age (no more than 10% will be older than 50 years of age; at least 40% will be 25 years of age or less), without identifiable intermediate or higher-risk behavior.

Schema:

 

 
T: 50 µg HIV-1 SF-2 rgp120 in MF59 Adjuvant Emulsion
C: MF59 adjuvant emulsion (formulated as Placebo Vaccine 2)

Immunization Schedule in Months

Group

Accrual

0

1

6

9

12

A

24

T

T

T

T

T

B

6

C

C

C

C

C

ACCRUAL, IMMUNIZATIONS AND FOLLOW-UP COMPLETED

 

Product Description: CHO cell-derived HIV-1 SF-2 rgp120 in combination with MF59 adjuvant emulsion [Chiron/BIOCINE]

Time Period: First volunteer enrolled on 09/18/95 and the last on 01/02/96; follow-up of 24 months with the possibility of extension.

Clinical Sites: University of Washington, Johns Hopkins University, Saint Louis University, University of Alabama at Birmingham, University of Rochester, Vanderbilt University

Study Chair: Lawrence Corey, University of Washington

 

INCLUSION CRITERIA

Standard inclusion criteria

 

EXCLUSION CRITERIA

Standard exclusion criteria

 

STUDY GOALS