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N Engl J Med. Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine

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  • N Engl J Med. Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine

    [Source: The New England Journal of Medicine, full page: (LINK). Abstract, edited.]


    Original Article

    Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine

    Scott M. Hammer, M.D., Magdalena E. Sobieszczyk, M.D., M.P.H., Holly Janes, Ph.D., Shelly T. Karuna, M.D., Mark J. Mulligan, M.D., Doug Grove, M.S., Beryl A. Koblin, Ph.D., Susan P. Buchbinder, M.D., Michael C. Keefer, M.D., Georgia D. Tomaras, Ph.D., Nicole Frahm, Ph.D., John Hural, Ph.D., Chuka Anude, M.D., Ph.D., Barney S. Graham, M.D., Ph.D., Mary E. Enama, M.A., P.A.-C., Elizabeth Adams, M.D., Edwin DeJesus, M.D., Richard M. Novak, M.D., Ian Frank, M.D., Carter Bentley, Ph.D., Shelly Ramirez, M.A., Rong Fu, M.S., Richard A. Koup, M.D., John R. Mascola, M.D., Gary J. Nabel, M.D., Ph.D., David C. Montefiori, Ph.D., James Kublin, M.D., M.P.H., M. Juliana McElrath, M.D., Ph.D., Lawrence Corey, M.D., and Peter B. Gilbert, Ph.D. for the HVTN 505 Study Team

    October 7, 2013DOI: 10.1056/NEJMoa1310566


    Abstract

    Background

    A safe and effective vaccine for the prevention of human immunodeficiency virus type 1 (HIV-1) infection is a global priority. We tested the efficacy of a DNA prime–recombinant adenovirus type 5 boost (DNA/rAd5) vaccine regimen in persons at increased risk for HIV-1 infection in the United States.


    Methods

    At 21 sites, we randomly assigned 2504 men or transgender women who have sex with men to receive the DNA/rAd5 vaccine (1253 participants) or placebo (1251 participants). We assessed HIV-1 acquisition from week 28 through month 24 (termed week 28+ infection), viral-load set point (mean plasma HIV-1 RNA level 10 to 20 weeks after diagnosis), and safety. The 6-plasmid DNA vaccine (expressing clade B Gag, Pol, and Nef and Env proteins from clades A, B, and C) was administered at weeks 0, 4, and 8. The rAd5 vector boost (expressing clade B Gag-Pol fusion protein and Env glycoproteins from clades A, B, and C) was administered at week 24.


    Results

    In April 2013, the data and safety monitoring board recommended halting vaccinations for lack of efficacy. The primary analysis showed that week 28+ infection had been diagnosed in 27 participants in the vaccine group and 21 in the placebo group (vaccine efficacy, −25.0%; 95% confidence interval, −121.2 to 29.3; P=0.44), with mean viral-load set points of 4.46 and 4.47 HIV-1 RNA log<SUB>10</SUB> copies per milliliter, respectively. Analysis of all infections during the study period (41 in the vaccine group and 31 in the placebo group) also showed lack of vaccine efficacy (P=0.28). The vaccine regimen had an acceptable side-effect profile.


    Conclusions

    The DNA/rAd5 vaccine regimen did not reduce either the rate of HIV-1 acquisition or the viral-load set point in the population studied. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00865566.)


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