Data from several laboratories supports use of DNA-based vaccines to stimulate immune responses to HIV-1 Env and Rev encoding constructs in animals. This is the first study of APL 400-047 in HIV infected patients. The objectives of this study are to make initial ovservations on the safety and tolerability of the candidate vaccine and the immunogenicity of the vaccine, including evaluation of both humoral and cellular responses. This will be a randomized, blinded, vehicle-controlled, dose-escalating study. Nine HIV seropositive patients will be entered in each dose group. The first dose group will receive a 100 ug dose of APL 400-047 or equivalent diluent on Day 0, Day 28 (week 4) and Day 56 (week 8). In each dose group, three volunteers will receive diluent and six will receive APL 400-047. If the first injection of test vaccine is found safe and tolerable at the lower dose, 9 additional patients will be entered at the next dose level (300 ug). Additional patients (up to 18), may be added to better define observations made on safety, tolerability, or immune response. A total of up to 36 patients may be enteredinto the study.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000040-38A1
Application #
6274542
Study Section
Project Start
1998-04-15
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
38
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Pennsylvania
Department
Type
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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