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Safety of and Immune Response to the PENNVAX-B DNA Vaccine With and Without IL-12 in HIV-uninfected Adults

HIV Infections Clinical Trial

Official title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX™-B (Gag, Pol, Env) Vaccine, With or Without IL-12 DNA Plasmid, Delivered Via Electroporation in Healthy, HIV-1-Uninfected Adult Participants

Clinical Trial Summary

An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using electroporation.

Clinical Trial Description

An effective and safe vaccine must be developed in order to halt the HIV pandemic. The purpose of this study is to assess the safety and immune response to the HIV DNA vaccine, PENNVAX-B when given with and without an IL-12 adjuvant and delivered via electroporation. Participants in this study will be randomly assigned to one of three groups and will visit the study clinic 9 times over 9 months. Group 1 will enroll first. Participants in this group will receive 3 mg of the PENNVAX-B or placebo vaccine at Months 0, 1, and 3. Once safety data has been examined for Group 1, Group 2 will begin enrollment. Group 2 participants will receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3. Once Group 1 and Group 2 safety data have been collected Group 3 will begin enrollment. These participants will also receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3. At clinic visits participants will have physical exams and blood and urine collected. After receiving study injections, participants will be observed in the clinic for at least 30 minutes. In addition, participants will be asked to monitor symptoms for 3 days after each injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00991354
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date November 2009
Completion date March 2011
View Details
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