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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
24
National Centre in HIV Epidemiology and Clinical Research
Sydney, New South Wales, Australia
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
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
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