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Clin Vaccine Immunol. 2014 Nov;21(11):1589-99. doi: 10.1128/CVI.00450-14. Epub 2014 Sep 24.

Phase I/II randomized trial of safety and immunogenicity of LIPO-5 alone, ALVAC-HIV (vCP1452) alone, and ALVAC-HIV (vCP1452) prime/LIPO-5 boost in healthy, HIV-1-uninfected adult participants.

Author information

  • 1Department of Internal Medicine, Saint Louis University, St. Louis, Missouri, USA freyse@slu.edu.
  • 2Department of Medicine, University of California, San Francisco, California, USA.
  • 3Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, Washington, USA.
  • 4Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
  • 5Department of Medicine, University of Alabama, Birmingham, Alabama, USA.
  • 6Department of Medicine, University of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York, USA.
  • 7Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.
  • 8Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
  • 9The Fenway Institute, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, USA.
  • 10Institute of Human Virology, University of Maryland, Baltimore, Maryland, USA.
  • 11Center for Immunization Research, Johns Hopkins University, Baltimore, Maryland, USA.
  • 12Department of Medicine, Columbia University Medical Center, New York, New York, USA.
  • 13Department of Internal Medicine, Saint Louis University, St. Louis, Missouri, USA.
  • 14Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
  • 15Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.
  • 16Inserm, U955, Equipe 16, Université Paris Est, Faculté de Médecine, Vaccine Research Institute (VRI), Créteil, France.
  • 17SCHARP Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
  • 18Bill & Melinda Gates Foundation, Seattle, Washington, USA.
  • 19AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.

Abstract

Finding an effective human immunodeficiency virus type 1 (HIV-1) vaccine remains a major global health priority. In a phase I/II, placebo-controlled trial, healthy, HIV-1-negative adults were randomized to receive one of 5 vaccine regimens: LIPO-5 (combination of 5 lipopeptides) alone (250 μg), ALVAC-HIV (vCP1452) alone, or 3 groups of ALVAC-HIV (vCP1452) followed by ALVAC-HIV (vCP1452) plus LIPO-5 (250, 750, and 2,500 μg). Only 73/174 participants (42%) received all four vaccinations due to a study halt related to myelitis. There were no significant differences in systemic reactions between groups or in local reactogenicity between groups receiving ALVAC-HIV (vCP1452). Significant differences in local reactogenicity occurred between groups receiving LIPO-5 (P ≤ 0.05). Gag and Env antibodies were undetectable by ELISA 2 weeks after the fourth vaccination for all but one recipient. Antibodies to Gag and Env were present in 32% and 24% of recipients of ALVAC-HIV (vCP1452) alone and in 47% and 35% of ALVAC-HIV (vCP1452)+LIPO recipients, respectively. Coadministration of LIPO-5 did not significantly increase the response rate compared to ALVAC-HIV (vCP1452) alone, nor was there a significant relationship between dose and antibody responses among ALVAC-HIV (vCP1452)+LIPO groups. Over 90% of study participants had no positive gamma interferon (IFN-γ) enzyme-linked immunosorbent spot assay (ELISpot) responses to any peptide pool at any time point. The study was halted due to a case of myelitis possibly related to the LIPO-5 vaccine; this case of myelitis remains an isolated event. In general, there was no appreciable cell-mediated immunity detected in response to the vaccines used in this study, and antibody responses were limited. The clinical trial is registered on ClinicalTrials.gov with registry number NCT00076063.

PMID:
25253665
PMCID:
PMC4248765
DOI:
10.1128/CVI.00450-14
[PubMed - indexed for MEDLINE]
Free PMC Article

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