A Randomised, Placebo-Controlled, Double-Blind, Phase I/IIa Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic DNA Prime-rFPV Boost HIV Vaccination Strategy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety and adverse events among the two vaccination groups
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
This study will examine the safety and immune response to a two-part HIV vaccine. Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo.
Detailed Description
The purpose of this study is to examine the safety and immunogenicity of a candidate vaccine strategy for HIV prophylaxis using a DNA-prime plus recombinant fowlpox boost. The DNA plasmid and fowlpox vector contain HIV genes. However, these vaccines contain only some HIV genes and cannot themselves cause HIV or AIDS. Eligible volunteers at low risk of HIV infection will be randomized to receive either active vaccine or placebo injections at Day 0, Week 4, and Week 8. Intensive immunologic and safety monitoring will be done during the first 16 weeks of the study. Follow-up will continue to Week 52.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety and adverse events among the two vaccination groups
lymphoproliferative (LP) responses to HIV antigens, as assessed by LP assays at Week 9
CD8+ T cell responses to HIV antigens, as assessed by ELIspot assay of interferon gamma (IFN-g) secreting cells at Week 9
Secondary Outcomes
- Proportion of patients with positive LP assay and ELISPOT assay responses
- intracellular cytokine staining (ICS) of IFN-g/CD69 and flow cytometry
- 51-Cr release cytotoxic T cell lymphocyte assay
- HLA class I tetramer analyses
- anti-HIV gag, pol and env antibodies, as assessed by ELISA and Western blot
- behavioral changes in study participants