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Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.

Publication ,  Journal Article
Hammer, SM; Sobieszczyk, ME; Janes, H; Karuna, ST; Mulligan, MJ; Grove, D; Koblin, BA; Buchbinder, SP; Keefer, MC; Tomaras, GD; Frahm, N ...
Published in: N Engl J Med
November 28, 2013

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 log10 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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 28, 2013

Volume

369

Issue

22

Start / End Page

2083 / 2092

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Vaccines, DNA
  • Treatment Failure
  • Transgender Persons
  • RNA, Viral
  • Middle Aged
  • Male
  • Incidence
  • Immunogenetic Phenomena
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hammer, S. M., Sobieszczyk, M. E., Janes, H., Karuna, S. T., Mulligan, M. J., Grove, D., … HVTN 505 Study Team. (2013). Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med, 369(22), 2083–2092. https://doi.org/10.1056/NEJMoa1310566
Hammer, Scott M., Magdalena E. Sobieszczyk, Holly Janes, Shelly T. Karuna, Mark J. Mulligan, Doug Grove, Beryl A. Koblin, et al. “Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.N Engl J Med 369, no. 22 (November 28, 2013): 2083–92. https://doi.org/10.1056/NEJMoa1310566.
Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, et al. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013 Nov 28;369(22):2083–92.
Hammer, Scott M., et al. “Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.N Engl J Med, vol. 369, no. 22, Nov. 2013, pp. 2083–92. Pubmed, doi:10.1056/NEJMoa1310566.
Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, Frahm N, Hural J, Anude C, Graham BS, Enama ME, Adams E, DeJesus E, Novak RM, Frank I, Bentley C, Ramirez S, Fu R, Koup RA, Mascola JR, Nabel GJ, Montefiori DC, Kublin J, McElrath MJ, Corey L, Gilbert PB, HVTN 505 Study Team. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013 Nov 28;369(22):2083–2092.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 28, 2013

Volume

369

Issue

22

Start / End Page

2083 / 2092

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Load
  • Vaccines, DNA
  • Treatment Failure
  • Transgender Persons
  • RNA, Viral
  • Middle Aged
  • Male
  • Incidence
  • Immunogenetic Phenomena