Protocol 016A

OUTLINE OF PROTOCOL 016A

A PHASE I, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED HIV-1 CLINICAL TRIAL TO EVALUATE AND COMPARE THE SAFETY AND IMMUNOGENICITY OF MN RGP120/HIV-1 IN COMBINATION WITH QS21 ADJUVANT AND/OR ALUM IN HEALTHY ADULTS

Subjects: Healthy, HIV-1 uninfected (seronegative) adult volunteers who meet the eligibility criteria. Volunteers will not be excluded on the basis of HIV risk behaviors. [Number of Subjects = 110]*

Schema:

MN rsgp120/HIV-1	QS21	0, 1, 2 MONTHS		0, 1, 6 MONTHS
MN rsgp120/HIV-1	QS21	WITH ALUM	WITHOUT ALUM	WITH ALUM	WITHOUT ALUM
300 µg	100 µg	20	20	20	20
0 µg	100 µg	5	5	5	5
0 µg	0 µg	5 (Alum alone)		5 (Alum alone)

* Total of 118 volunteers enrolled.

ACCRUAL, IMMUNIZATIONS AND FOLLOW-UP COMPLETED

Product Description: CHO cell-derived HIV-1 MN rsgp120 in combination with QS21 ± alum [Genentech]

Time Period: First volunteer enrolled on 05/17/94 and last on 03/17/95; follow-up of 18 months.

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

Study Chair: Julie McElrath, University of Washington

INCLUSION CRITERIA

Standard inclusion criteria, with the exception of those related to risk of HIV infection.

EXCLUSION CRITERIA

Standard exclusion criteria, with the exception of those related to risk of HIV infection, and the addition of:

History of allergy to thimerosal.

STUDY GOALS

The goal of this study is to extend the evaluation of safety and immunogenicity of MN rsgp120/HIV-1 in combination with QS21 with or without alum. This study addresses the following issues that cannot be answered by the original Protocol 016:

Clarify the effect of alum on the adjuvant properties of QS21 by increasing the sample size for this direct comparison.
Examine whether immune responses elicited after three immunizations are significantly different between a 0, 1, 2 month and a 0, 1, 6 month schedule.
Determine the safety of administration of QS21 with the candidate HIV vaccine in a larger number of volunteers, including some at higher risk for infection with HIV.