• Login
    View Item 
    •   UCUDIR Home
    • Research Papers and Publications
    • School of Medicine
    • View Item
    •   UCUDIR Home
    • Research Papers and Publications
    • School of Medicine
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    A Phase 2 Study to Evaluate the Safety and Immunogenicity of a Recombinant HIV Type 1 Vaccine Basedon Adeno-Associated Virus.

    Thumbnail
    View/Open
    The final, definitive version of this paper has been published in the AIDs Research and Human Retroviruses, Vol.26, Number 8, August/2010. DOI: 10.1089/aid.2009.0242; Published by Mary Ann Liebert, Inc. All rights reserved. (539.7Kb)
    Date
    2010-08-12
    Author
    Vardas, Eftyhia
    Kaleebu, Pontiano
    Bekker, Linda-Gail
    Hoosen, Anwar
    Chomba, Elwyn
    Johnson, Philip R.
    Anklesaria, Pervin
    Birungi, Josephine
    Barin, Burc
    Boaz, Mark
    Cox, Josephine
    Lehrman, Jennifer
    Stevens, Gwynn
    Gilmour, Jill
    Tarragona, Tony
    Hayes, Peter
    Lowenbein, Sarah
    Kizito, Eva
    Fast, Patricia
    Heald, Alison E.
    Schmidt, Claudia
    Metadata
    Show full item record
    Abstract
    The recombinant vaccine, tgAAC09, based on an adeno-associated virus serotype 2 (AAV2) vector encoding HIV-1 subtype C Gag, protease, and part of reverse transcriptase, induced robust T cell and antibody responses in nonhuman primates. In a previous phase I study in 80 healthy HIV-seronegative European and Indian adults, the vaccine was generally safe, well tolerated, and modestly immunogenic when administered once at doses up to 3x10 11 DRP. This phase II double-blind, randomized, placebo-controlled trial tested two administrations and a higher dosage of tgAAC009. Ninety-one healthy HIV-seronegative adults from three African countries were given one of three dosage levels of tgAAC09 (3x1010, 3x10 11, or 3x10 12 DRP) intramuscularly, either at a 6- or 12-month interval; follow-up was 18 months. Overall, 65% and 57% of vaccine recipients experienced local and systemic signs and symptoms, respectively, most being mild. Frequency and severity were not dose related and were similar to those in placebo recipients. No vaccine-related serious adverse events were reported. Overall, HIV-specific T cell responses were detected by IFN-g ELISPOT in 17/69 (25%) vaccine recipients with 38% (10/26) responders in the highest dosage group. The response rate improved significantly with boosting at 6, but not 12 months, in the 3x10 11 and 3x10 12 dosage groups only. Neutralizing antibody titers to the AAV2 did not alter the frequency of immune responses to HIV. Two doses of tgAAC09 were well tolerated at the dosage levels given. Fewer than half the recipients of the highest vaccine dosage, 3x10 12 DRP, had T cell responses to HIV.
    Use this URI to cite this item:
    https://hdl.handle.net/20.500.11951/274
    Collections
    • School of Medicine [158]

    UCUDIR copyright © 2017-2019  UCU Library |  Search Library Catalogue
    Contact Us | Send Feedback
     
    Atmire NV
     

     

    Browse

    All of UCUDIRCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    View Usage Statistics

    UCUDIR copyright © 2017-2019  UCU Library |  Search Library Catalogue
    Contact Us | Send Feedback
     
    Atmire NV