Subjects: Healthy, HIV-1 uninfected adult volunteers of either gender, 18-60 years of age (no more than 10% will be older than 50 years of age) having lower risk behavior [Number of subjects = 60]

Schema:

vCP1452: ALVAC-HIV (vCP1452), approximate dose of 106.7TCID50 vCP205: ALVAC-HIV (vCP205), approximate dose of 106.3 TCID50 PA: Placebo-ALVAC
Group	Total Volunteers	Immunization Schedule in Months
		0	1	3	6
V	40	vCP1452	vCP1452	vCP1452	vCP1452
VI	15	vCP205	vCP205	vCP205	vCP205
VII	5	PA	PA	PA	PA
Total =	60	Note: Due to the unavailability of ALVAC-RG, Placebo-ALVAC is being used as the control for Amendment III.

Boldface indicates ongoing activity

Product Description: ALVAC-HIV vCP205 is a recombinant canarypox vector into which the following genes have been inserted: HIV-1 envelope gp120 (strain MN) linked to the transmembrane portion of HIV-1 gp41 (strain LAI) and the HIV-1 LAI genes encoding the entire gag protein and a portion of the pol sequence, sufficient to evoke the protease portion. [Pasteur Merieux Connaught]

ALVAC-HIV vCP1452 vaccine is a modified recombinant canarypox virus expressing the same HIV gene products as vCP205 and the human CTL epitopes from the nef and pol gene products. In addition, two vaccinia virus coding sequences have been added to enhance the overall efficiency of viral mRNA translation, with the goal of increasing expression of the HIV gene products. [Pasteur Merieux Connaught]

Time Period: 12 months, with possibility of extension; first volunteer enrolled on 09/27/99 and the last on 12/02/99.

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

Study Chair: David Schwartz, Johns Hopkins University

INCLUSION CRITERIA

Standard inclusion criteria.

EXCLUSION CRITERIA

Standard exclusion criteria, with the addition of:

• Allergy to eggs or neomycin

STUDY GOALS

• To compare the CTL induction in this protocol amendment using vector-only immunization with that seen in the initial part of the protocol (Protocol 034), including comparisons of the CTL induction by vCP1452 alone (Protocol 034A) vs. the combination of vCP1452 with gp160 (original Protocol 034).