OUTLINE OF PROTOCOL 017

 

A PHASE I SAFETY AND IMMUNOGENICITY TRIAL OF UBI® MULTIVALENT HIV-1 PEPTIDE IMMUNOGEN

 

Subjects: Healthy, HIV-1 uninfected adult volunteers without identifiable higher-risk behavior for HIV-1 infection, as determined by a comprehensive screening questionnaire. [Total = 28 volunteers]

Schema:
UBI® Multivalent
HIV-1 Peptide
Immunogen


Placebo


Immunization Schedule (Months)
Group

Dose

Accrual

Number

0

1

6

8-10*
I

300 µg

12

2

X

X

X

X
II

1200 µg

12

2

X

X

X

X
* The optional fourth immunization given 8-10 months after the first immunization

ACCRUAL, IMMUNIZATIONS, AND FOLLOW-UP COMPLETED

 

Product Description: The UBI® Multivalent HIV-1 Peptide Immunogen is a mixture of HIV-1 gp120 principal neutralizing domain (PND) V3 branched synthetic peptides from 15 HIV-1 strains from 5 subtypes and formulated in alum. Each component of the vaccine consists of 8 V3-derived homologous peptides attached to a heptalysyl core to form radially branched structures. [United Biomedical, Inc.]

Time Period: First volunteer enrolled on 02/14/94 and the last on 07/14/94; follow-up extended to 6 months beyond last immunization.

Clinical Sites: University of Rochester, Johns Hopkins University

Study Chair: Michael Keefer, University of Rochester

 

INCLUSION CRITERIA

Standard inclusion criteria.

 

EXCLUSION CRITERIA

Standard exclusion criteria.

 

STUDY GOALS

The aims of this Phase I study are to evaluate the safety and immunogenicity of a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched synthetic peptides (in alum) from 15 viral strains representative of diverse worldwide isolates, in healthy adult volunteers at lower or intermediate risk for acquiring HIV-1 infection. Specific questions to be addressed include: