Protocol 011

OUTLINE OF PROTOCOL 011

A PHASE I SAFETY AND IMMUNOGENICITY TRIAL OF UNITED BIOMEDICAL, INC. (UBI) SYNVAC HIV-1 MN OCTAMERIC V3 PEPTIDE VACCINE

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

Schema:

Group	Treatment	Accrual	Immunization Schedule
Group	Treatment	Accrual	Day 0	Day 28	Day 168
I*	20 µg Oct. V3 Peptide Placebo	11 2	X X	X X	X X
II*	100 µg Oct. V3 Peptide Placebo	13 2	X X	X X	X X
III	500 µg Oct. V3 Peptide Placebo	10 2	X X	X X	X X
Total		n = 40

* At least 8 volunteers in Groups I and II were monitored for 1 week prior to enrolling volunteers at the next dose level. Additional volunteers were enrolled in Groups I and II to compensate for dropouts

ACCRUAL, IMMUNIZATIONS, AND FOLLOW-UP COMPLETED

Product Description: HIV-1 MN octameric V3 (PND) synthetic peptide immunogen formulated in alum [UBI]

Time Period: First volunteer enrolled 02/04/93 and last entered on 06/07/93; follow-up of 32 weeks (224 days).

Clinical Sites: Saint Louis University and University of Rochester

Study Chair: Geoffrey Gorse, Saint Louis University

INCLUSION CRITERIA

Standard AVEG inclusion criteria

EXCLUSION CRITERIA

Standard AVEG exclusion criteria

STUDY GOALS

The aims of this Phase I study are to evaluate the safety and immunogenicity of SynVac in healthy adult volunteers at lower risk for acquiring HIV-1 infection. Specific questions to be addressed include:

Are there any adverse clinical reactions or laboratory evidence of toxicities to the candidate vaccine (i.e., local or systemic reactions or immunologic impairment)?
Does the candidate vaccine induce anti-HIV-1 antibodies? In particular, does it stimulate homologous and heterologous anti-HIV-1 neutralizing antibody in healthy volunteers?
Does the candidate vaccine stimulate cell-mediated immune responses including CD4+ and CD8+ cytotoxic T-cell activity and lymphocyte proliferation?

REFERENCE

Gorse GJ, Keefer MC, Belshe RB, Matthews TJ, Forrest BD, Hsieh RH, Koff WC, Hanson CV, Dolin R, Weinhold KJ, Frey SE, Ketter N, Fast PE (National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group). A dose-ranging study of a prototype synthetic HIV-1_MN V3 branched peptide vaccine. J Infect Dis. 1996;173:330-339.