Journal article
Safety and immunogenicity of DNA prime and modified vaccinia ankara virus-HIV subtype c vaccine boost in healthy adults
P Hayes, J Gilmour, AV Lieven, D Gill, L Clark, J Kopycinski, H Cheeseman, A Chung, G Alter, L Dally, D Zachariah, A Lombardo, J Ackland, E Sayeed, A Jackson, M Boffito, B Gazzard, PE Fast, JH Cox, D Laufer
Clinical and Vaccine Immunology | AMER SOC MICROBIOLOGY | Published : 2013
DOI: 10.1128/CVI.00637-12
Abstract
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-γ) 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-γ ELISPOT responses were detected in 6/12 (50%) and 7/11 (64%) individuals after the sec..
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Awarded by National Institute of Allergy and Infectious Diseases
Funding Acknowledgements
This study was sponsored by the International AIDS Vaccine Initiative and funded by its donors, including the United States Agency for International Development (USAID Cooperative Agreement Number GPO-A-00-06-00006-00), the Governments of Canada, Denmark, Ireland, The Netherlands, Norway, Sweden, and the United Kingdom, the Basque Autonomous Government, the European Union, and the Bill & Melinda Gates Foundation. The Luminex antibody assays were conducted at the Ragon Institute and supported by the National Institutes of Health (R01AI080289), the American-Australian Association (AAA), and National Health and Medical Research Center (APP1036470).