Protocol 013B

OUTLINE OF PROTOCOL 013B

A PHASE I MULTICENTER CLINICAL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF VACCINIA DERIVED MN HIV-1 RECOMBINANT ENVELOPE GLYCOPROTEIN (RGP160) OF HUMAN IMMUNODEFICIENCY VIRUS AT TWO DIFFERENT VACCINATION SCHEDULES

Subjects: Healthy, HIV-1 uninfected adult volunteers without identifiable high-risk behavior for HIV-1 infection, as determined by comprehensive prescreening evaluation.

Schema:

T1: C: T2:		MN rpg160 (800 µg ) [IMMUNO-AG] Adjuvant Control [IMMUNO-AG] MN rgp120 (600 µg) [Genentech]
Group	Accrual	Immunization Schedule in Days
Group	Accrual	0	28	56	168	224	336	392	616*	672*
A	8	T1	T1	.	T1	.	T1	.	T2	T2
B	2	C	C	.	C	.	C	.	T2	T2
C	8	T1	.	T1	.	T1	.	T1	T2	T2
D	2	C	.	C	.	C	.	C	T2	T2

* Study Extension: Immunizations for Saint Louis University volunteers only

ACCRUAL, IMMUNIZATIONS AND FOLLOW-UP COMPLETED

Product Description:

Vaccinia/Vero cell-expressed HIV-1 MN rgp160 in alum and deoxycholate (DOC) [IMMUNO-AG]
CHO cell-derived HIV-1 MN rgp120 in alum [Genentech]

Time Period: First volunteer enrolled on 01/23/95 and the last on 03/14/95; follow-up extended to 26 months for volunteers who received immunizations at Days 616 and 672.

Clinical Sites: Saint Louis University, University of Washington

Study Chair: Geoffrey Gorse, Saint Louis University

INCLUSION CRITERIA

Standard AVEG inclusion criteria.

EXCLUSION CRITERIA

Standard AVEG exclusion criteria.

STUDY GOALS

To evaluate the 800 µg MN rgp160 dose on one of two schedules (0, 1, 6 and 12 months or 0, 2, 8 and 14 months).
To measure the safety and immunogenicity of a higher dose of this candidate vaccine given in two dose schedules.
To evaluate skin test reactivity to IIIB and MN rgp160 after the fourth immunization and compare the delayed type hypersensitivity skin test reactivity with concomitantly measured lymphocyte proliferation stimulated by IIIB and MN rgp160 in PBMC collected at the same time as administration of the skin test. MN and IIIB rgp160 (IMMUNO-AG) skin test antigen at 1 µg and 3 µg/dose and a control mock prep skin test antigen are available.
To evaluate the safety and immunogenicity of boosting volunteers, who have already received four immunizations of HIV-1 MN rgp160, with HIV-1 MN rgp120.

REFERENCE

Gorse GJ, Corey L, Patel GB, Mandava M, Hsieh RH, Matthews TJ, Walker MC, McElrath MJ, Berman PW, Eibl MM, Belshe RB (National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group). HIV-1_MN recombinant glycoprotein 160 vaccine-induced cellular and humoral immunity boosted by HIV-1_MN recombinant glycoprotein 120 vaccine. AIDS Res Hum Retroviruses. 1999;15:115-132.