A PHASE Ib PARTIALLY RANDOMIZED PILOT STUDY INTENDED TO EVALUATE THE SAFETY AND IMMUNOLOGICAL EFFECTS OF HIV-1 DNA IMMUNIZATION (PENNVAX-B) WITH OR WITHOUT CO-ADMINISTRATION OF CONSTRUCTS CONTAINING DNA ENCODING FOR THE EXPRESSION OF EITHER IL-12 OR IL-15 IN HIV INFECTED INDIVIDUALS

NCT00775424 Phase 1 COMPLETED

A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15. Primary objectives 1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B). 2. To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs when given with PENNVAX-B. Secondary objectives 1. To compare the various vaccine groups for their immunological responses to several HIV-1 antigens, utilizing the ELISPOT assay. 2. To analyze antibody responses to the vaccine antigens over time. 3. To measure CD8 cell proliferative responses to vaccine antigens over time.

Details

Lead sponsor	University of Pennsylvania
Phase	Phase 1
Status	COMPLETED
Enrolment	38
Start date	2008-09
Completion	2010-06

Conditions

• HIV Infection

Interventions

• PENNVAX-B
• GENEVAX IL-12-4532
• PLACEBO
• IL-15 adjuvant

Primary outcomes

• Frequency of adverse events in each of the treatment arms — Time of each vaccination, 2 weeks after vaccinations 3 and 4 and at the completion of the study.

Countries

United States