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Ex vivo production of autologous whole inactivated HIV-1 for clinical use in therapeutic vaccines

  1. Author:
    Gil, C.
    Climent, N.
    Garcia, F.
    Hurtado, C.
    Nieto-Marquez, S.
    Leon, A.
    Garcia, M. T.
    Rovira, C.
    Miralles, L.
    Dalmau, J.
    Pumarola, T.
    Almela, M.
    Martinez-Picado, J.
    Lifson, J. D.
    Zamora, L.
    Miro, J. M.
    Brander, C.
    Clotet, B.
    Gallart, T.
    Gatell, J. M.

  2. Author Address

    [Gil, C; Garcia, F; Miro, JM; Gatell, JM] Hosp Clin Barcelona, Infect Dis Serv, E-08036 Barcelona, Spain. [Gil, C; Garcia, F; Miro, JM; Gatell, JM] Hosp Clin Barcelona, AIDS Unit, E-08036 Barcelona, Spain. [Pumarola, T; Almela, M; Gallart, T] Univ Barcelona, Hosp Clin Barcelona, E-08007 Barcelona, Spain. [Dalmau, J; Martinez-Picado, J; Brander, C; Clotet, B] Hosp Badalona Germans Trias & Pujol, Inst Recerca SIDA IrsiCaixa HIVACAT, Barcelona, Spain. [Martinez-Picado, J; Brander, C] ICREA, Barcelona, Spain. [Lifson, JD] NCI Frederick, AIDS & Canc Virus Program, SAIC Frederick Inc, Frederick, MD 21702 USA.;Gil, C (reprint author), Hosp Clin Barcelona, Infect Dis Serv, Villarroel 170, E-08036 Barcelona, Spain;cgil@clinic.ub.es
    1. Year: 2011
    2. Date: Aug
  2. Journal: Vaccine
    1. 29
    2. 34
    3. Pages: 5711-5724
  4. Type of Article: Article
  5. ISSN: 0264-410X
  1. Abstract:

    This study provides a detailed description and characterization of the preparation of individualized lots of autologous heat inactivated HIV-1 virions used as immunogen in a clinical trial designed to test an autologous dendritic-cell-based therapeutic HIV-1 vaccine (Clinical Trial DCV-2, NCT00402142). For each participant, ex vivo isolation and expansion of primary virus were performed by co-culturing CD4-enriched PBMCs from the HIV-1-infected patient with PBMC from HIV-seronegative unrelated healthy volunteer donors. The viral supernatants were heat-inactivated and concentrated to obtain 1 mL of autologous immunogen, which was used to load autologous dendritic cells of each patient. High sequence homology was found between the inactivated virus immunogen and the HIV-1 circulating in plasma at the time of HIV-1 isolation. Immunogens contained up to 10(9) HIV-1 RNA copies/mL showed considerably reduced infectivity after heat inactivation (median of 5.6 log(10)), and were free of specified adventitious agents. The production of individualized lots of immunogen based on autologous inactivated HIV-1 virus fulfilling clinical-grade good manufacturing practice proved to be feasible, consistent with predetermined specifications, and safe for use in a clinical trial designed to test autologous dendritic cell-based therapeutic HIV-1 vaccine. (C) 2011 Elsevier Ltd. All rights reserved.

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External Sources

  1. View Full Text
  2. DOI: 10.1016/j.vaccine.2011.05.096
  3. View record in Web of Science®
  4. WOS: 000294145800020

Library Notes

  1. Fiscal Year: FY2010-2011
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