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First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).

Publication ,  Journal Article
Fuchs, JD; Frank, I; Elizaga, ML; Allen, M; Frahm, N; Kochar, N; Li, S; Edupuganti, S; Kalams, SA; Tomaras, GD; Sheets, R; Pensiero, M ...
Published in: Open Forum Infect Dis
September 2015

Background.  We report the first-in-human safety and immunogenicity evaluation of a highly attenuated, replication-competent recombinant vesicular stomatitis virus (rVSV) human immunodeficiency virus (HIV)-1 vaccine. Methods.  Sixty healthy, HIV-1-uninfected adults were enrolled in a randomized, double-blinded, placebo-controlled dose-escalation study. Groups of 12 participants received rVSV HIV-1 gag vaccine at 5 dose levels (4.6 × 10(3) to 3.4 × 10(7) particle forming units) (N = 10/group) or placebo (N = 2/group), delivered intramuscularly as bilateral injections at 0 and 2 months. Safety monitoring included VSV cultures from blood, urine, saliva, and swabs of oral lesions. Vesicular stomatitis virus-neutralizing antibodies, T-cell immunogenicity, and HIV-1 specific binding antibodies were assessed. Results.  Local and systemic reactogenicity symptoms were mild to moderate and increased with dose. No severe reactogenicity or product-related serious adverse events were reported, and all rVSV cultures were negative. All vaccine recipients became seropositive for VSV after 2 vaccinations. gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost. Conclusions.  An attenuated replication-competent rVSV gag vaccine has an acceptable safety profile in healthy adults. This rVSV vector is a promising new vaccine platform for the development of vaccines to combat HIV-1 and other serious human diseases.

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Published In

Open Forum Infect Dis

DOI

ISSN

2328-8957

Publication Date

September 2015

Volume

2

Issue

3

Start / End Page

ofv082

Location

United States

Related Subject Headings

  • 3207 Medical microbiology
  • 3202 Clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Fuchs, J. D., Frank, I., Elizaga, M. L., Allen, M., Frahm, N., Kochar, N., … Ferrara, A. (2015). First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090). Open Forum Infect Dis, 2(3), ofv082. https://doi.org/10.1093/ofid/ofv082
Fuchs, Jonathan D., Ian Frank, Marnie L. Elizaga, Mary Allen, Nicole Frahm, Nidhi Kochar, Sue Li, et al. “First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).Open Forum Infect Dis 2, no. 3 (September 2015): ofv082. https://doi.org/10.1093/ofid/ofv082.
Fuchs JD, Frank I, Elizaga ML, Allen M, Frahm N, Kochar N, et al. First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090). Open Forum Infect Dis. 2015 Sep;2(3):ofv082.
Fuchs, Jonathan D., et al. “First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).Open Forum Infect Dis, vol. 2, no. 3, Sept. 2015, p. ofv082. Pubmed, doi:10.1093/ofid/ofv082.
Fuchs JD, Frank I, Elizaga ML, Allen M, Frahm N, Kochar N, Li S, Edupuganti S, Kalams SA, Tomaras GD, Sheets R, Pensiero M, Tremblay MA, Higgins TJ, Latham T, Egan MA, Clarke DK, Eldridge JH, HVTN 090 Study Group and the National Institutes of Allergy and Infectious Diseases HIV Vaccine Trials Network, Mulligan M, Rouphael N, Estep S, Rybczyk K, Dunbar D, Buchbinder S, Wagner T, Isbell R, Chinnell V, Bae J, Escamilla G, Tseng J, Fair R, Ramirez S, Broder G, Briesemeister L, Ferrara A. First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090). Open Forum Infect Dis. 2015 Sep;2(3):ofv082.
Journal cover image

Published In

Open Forum Infect Dis

DOI

ISSN

2328-8957

Publication Date

September 2015

Volume

2

Issue

3

Start / End Page

ofv082

Location

United States

Related Subject Headings

  • 3207 Medical microbiology
  • 3202 Clinical sciences