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Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 Canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120.

Publication ,  Journal Article
Cleghorn, F; Pape, JW; Schechter, M; Bartholomew, C; Sanchez, J; Jack, N; Metch, BJ; Hansen, M; Allen, M; Cao, H; Montefiori, DC; Tomaras, GD ...
Published in: J Acquir Immune Defic Syndr
October 1, 2007

BACKGROUND: The first multicenter, international National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored HIV vaccine trial took place in Brazil, Haiti, Peru and Trinidad. This randomized, double-blind, placebo-controlled, phase 2 trial evaluated the safety and immunogenicity of a clade B-derived, live canarypox HIV vaccine, vCP1452. vCP1452 was administered alone or with a heterologous boost of MN rgp120 glycoprotein. The trial was pivotal in deciding whether these vaccines advanced to phase 3 efficacy trials. METHODS: Forty seronegative volunteers per site were randomized to ALVAC alone, ALVAC plus MN rgp120, or placebo in a 0, 1, 3, and 6 month schedule. Immunogenicity was assayed by chromium-release cytotoxic T lymphocyte (CTL) responses; interferon-gamma (IFN-gamma) enzyme-linked immunosorbent spot assays (ELISpot); lymphocyte proliferation assays (LPA); neutralization; and enzyme-linked immunosorbent assays (ELISA). RESULTS: Enrollment and follow-up were excellent. Both vaccines were well tolerated. Neutralizing antibody to the laboratory-adapted MN strain was detected. Cellular immune responses, as measured by CTL, ELISpot, and LPA, did not differ between vaccines and placebos. CONCLUSIONS: The observation of disappointing immunogenicity in this and a parallel domestic study has informed future vaccine development. Equally important, challenges to doing an integrated trial across countries, cultures, languages, and differing at-risk populations were overcome. The identification of specific safety, ethical, logistic, and immunological issues in this trial established the foundation for current larger international studies.

Duke Scholars

Published In

J Acquir Immune Defic Syndr

DOI

ISSN

1525-4135

Publication Date

October 1, 2007

Volume

46

Issue

2

Start / End Page

222 / 230

Location

United States

Related Subject Headings

  • Virology
  • Vaccines, Synthetic
  • Vaccination
  • Trinidad and Tobago
  • Treatment Outcome
  • T-Lymphocytes, Cytotoxic
  • Peru
  • Neutralization Tests
  • Middle Aged
  • Male
 

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Cleghorn, F., Pape, J. W., Schechter, M., Bartholomew, C., Sanchez, J., Jack, N., … 026 Protocol Team and the NIAID HIV Vaccine Trials Network. (2007). Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 Canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120. J Acquir Immune Defic Syndr, 46(2), 222–230. https://doi.org/10.1097/QAI.0b013e318149297d
Cleghorn, Farley, Jean W. Pape, Mauro Schechter, Courtenay Bartholomew, Jorge Sanchez, Noreen Jack, Barbara J. Metch, et al. “Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 Canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120.J Acquir Immune Defic Syndr 46, no. 2 (October 1, 2007): 222–30. https://doi.org/10.1097/QAI.0b013e318149297d.
Cleghorn F, Pape JW, Schechter M, Bartholomew C, Sanchez J, Jack N, et al. Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 Canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):222–30.
Cleghorn, Farley, et al. “Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 Canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120.J Acquir Immune Defic Syndr, vol. 46, no. 2, Oct. 2007, pp. 222–30. Pubmed, doi:10.1097/QAI.0b013e318149297d.
Cleghorn F, Pape JW, Schechter M, Bartholomew C, Sanchez J, Jack N, Metch BJ, Hansen M, Allen M, Cao H, Montefiori DC, Tomaras GD, Gurunathan S, Eastman DJ, do Lago RF, Jean S, Lama JR, Lawrence DN, Wright PF, 026 Protocol Team and the NIAID HIV Vaccine Trials Network. Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 Canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):222–230.

Published In

J Acquir Immune Defic Syndr

DOI

ISSN

1525-4135

Publication Date

October 1, 2007

Volume

46

Issue

2

Start / End Page

222 / 230

Location

United States

Related Subject Headings

  • Virology
  • Vaccines, Synthetic
  • Vaccination
  • Trinidad and Tobago
  • Treatment Outcome
  • T-Lymphocytes, Cytotoxic
  • Peru
  • Neutralization Tests
  • Middle Aged
  • Male