Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
- Conditions
- HIV Infections
- Registration Number
- NCT00051454
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
National Centre in HIV Epidemiology and Clinical Research
🇦🇺Sydney, New South Wales, Australia