Protocol 013A

OUTLINE OF PROTOCOL 013A

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:

Group	N	Vaccine	Immunization Schedule in Days
Group	N	Vaccine	0	28	56	168	224	532**
A	10	MN gp160 (200 µg)	X	X		X		X
B	2	Placebo	X	X		X		X
C	10	MN gp160 (200 µg)	X		X		X	X
D	2	Placebo	X		X		X	X

** Study Extension: At Day 532, 5 volunteers in each of Groups A and C received 200 µg and 5 volunteers received 800 µg of MN rgp160

ACCRUAL, IMMUNIZATIONS, AND FOLLOW-UP COMPLETED

Product Description: Vaccinia/Vero cell-expressed HIV-1 MN rgp160 in alum and deoxycholate (DOC) [IMMUNO-AG]

Time Period: First volunteer entered on 04/06/93 and last enrolled on 07/01/93; follow-up of 18 months extended to 24 months for those volunteers who received the fourth immunization.

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

The purpose of Protocol 013A is to determine the safety and immunogenicity of 200 µg of HIV-1 MN rgp160 (IMMUNO-AG) given in two immunization schedules (0, 1, 6 or 0, 2 8 months).
Study Extension: To evaluate the safety and immunogenicity of an additional dose of the candidate vaccine at either the same dose (200 µg) or 800 µg.

REFERENCE

Gorse GJ, McElrath MJ, Matthews TJ, Hsieh RH, Belshe RB, Corey L, Frey SE, Kennedy DJ, Walker MC, Eibl MM, National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. Modulation of immunologic responses to HIV-1MN recombinant gp160 vaccine by dose and schedule of administration. Vaccine. 1998;16:493-506.