Journal
CLINICAL AND VACCINE IMMUNOLOGY
Volume 20, Issue 3, Pages 397-408Publisher
AMER SOC MICROBIOLOGY
DOI: 10.1128/CVI.00637-12
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Funding
- International AIDS Vaccine Initiative
- United States Agency for International Development (USAID) [GPO-A-00-06-00006-00]
- Government of Canada
- Government of Denmark
- Government of Ireland
- Government of The Netherlands
- Government of Norway
- Government of Sweden
- Government of United Kingdom
- Basque Autonomous Government
- European Union
- Bill & Melinda Gates Foundation
- National Institutes of Health [R01AI080289]
- American-Australian Association (AAA)
- National Health and Medical Research Center [APP1036470]
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A randomized, double-blind, placebo-controlled phase I trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of 3 doses of DNA vaccine (Advax) plus 1 dose of recombinant modified vaccinia virus Ankara (MVA) (TBC-M4) or 3 doses of TBC-M4 alone (groups A and B, respectively). Both vaccine regimens were found to be safe and well tolerated. Gamma interferon (IFN-gamma) enzyme-linked immunosorbent spot (ELISPOT) assay responses were detected in 1/10 (10%) individuals in group A after three Advax primes and in 9/9 individuals (100%) after the MVA boost. In group B, IFN-gamma ELISPOT responses were detected in 6/12 (50%) and 7/11 (64%) individuals after the second and third MVA vaccinations, respectively. Responses to all vaccine components, but predominantly to Env, were seen. The breadth and magnitude of the T cell response and viral inhibition were greater in group A than in group B, indicating that the quality of the T-cell response was enhanced by the DNA prime. Intracellular cytokine staining indicated that the T-cell responses were polyfunctional but were skewed toward Env with a CD4(+) phenotype. At 2 weeks after the last vaccination, HIV-specific antibody responses were detected in all (100%) group B and 1/11 (9.1%) group A vaccinees. Vaccinia virus-specific responses were detected in all (100%) group B and 2/11 (18.2%) group A vaccinees. In conclusion, HIV-specific T-cell responses were seen in the majority of volunteers in groups A and B but with a trend toward greater quality of the T-cell response in group A. Antibody responses were better in group B than in group A.
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