کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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2403268 | 1102891 | 2011 | 14 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Ex vivo production of autologous whole inactivated HIV-1 for clinical use in therapeutic vaccines Ex vivo production of autologous whole inactivated HIV-1 for clinical use in therapeutic vaccines](/preview/png/2403268.png)
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 109 HIV-1 RNA copies/mL showed considerably reduced infectivity after heat inactivation (median of 5.6 log10), 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.
Journal: Vaccine - Volume 29, Issue 34, 5 August 2011, Pages 5711–5724