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Phase 2 study of an HIV-1 canarypox vaccine (vCP1452) alone and in combination with rgp120: negative results fail to trigger a phase 3 correlates trial.

Publication ,  Journal Article
Russell, ND; Graham, BS; Keefer, MC; McElrath, MJ; Self, SG; Weinhold, KJ; Montefiori, DC; Ferrari, G; Horton, H; Tomaras, GD; Gurunathan, S ...
Published in: J Acquir Immune Defic Syndr
February 1, 2007

BACKGROUND: A goal of T-cell HIV vaccines is to define the correlation between a vaccine-induced immune response and protection from HIV infection. We conducted a phase 2 trial to determine if a canarypox vaccine candidate (vCP1452) administered with rgp120 subunit protein would "qualify" for a trial to define a correlate of efficacy. METHODS: A total of 330 healthy volunteers were enrolled into 4 groups: 120 received vCP1452 alone (0, 1, 3, and 6 months), 120 received vCP1452 with 2 different regimens of rgp120 coadministration, and 90 received placebo. HIV-specific antibody responses were measured by enzyme-linked immunoassay (ELISA) and neutralizing activity. T-cell responses were measured by chromium release and interferon-gamma (IFNgamma) enzyme-linked immunospot (ELISpot) assay. RESULTS: Significant neutralizing antibody responses to the HIV MN strain were detected in all vaccine groups, with net responses ranging from 57% (95% confidence interval [CI]: 40% to 71%) to 94% (95% CI: 85% to 99%). Net cumulative HIV-specific CD8 IFNgamma ELISpot assay responses were 13% (95% CI: -1% to 26%) for recipients of vCP1452 alone and 16% (95% CI: 2% to 29%) for recipients of vCP1452 plus rgp120. CONCLUSIONS: Overall, the HIV-specific CD8 cytotoxic T lymphocyte (CTL) response was not sufficient to qualify the regimen for a subsequent trial designed to detect an immune correlate of protection requiring a minimum CD8 CTL frequency of 30%.

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Published In

J Acquir Immune Defic Syndr

DOI

ISSN

1525-4135

Publication Date

February 1, 2007

Volume

44

Issue

2

Start / End Page

203 / 212

Location

United States

Related Subject Headings

  • Virology
  • Vaccines, Synthetic
  • Vaccines, Subunit
  • T-Lymphocytes, Cytotoxic
  • Neutralization Tests
  • Middle Aged
  • Male
  • Interferon-gamma
  • Humans
  • HIV-1
 

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Russell, N. D., Graham, B. S., Keefer, M. C., McElrath, M. J., Self, S. G., Weinhold, K. J., … National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network, . (2007). Phase 2 study of an HIV-1 canarypox vaccine (vCP1452) alone and in combination with rgp120: negative results fail to trigger a phase 3 correlates trial. J Acquir Immune Defic Syndr, 44(2), 203–212. https://doi.org/10.1097/01.qai.0000248356.48501.ff
Russell, Nina D., Barney S. Graham, Michael C. Keefer, M Juliana McElrath, Steve G. Self, Kent J. Weinhold, David C. Montefiori, et al. “Phase 2 study of an HIV-1 canarypox vaccine (vCP1452) alone and in combination with rgp120: negative results fail to trigger a phase 3 correlates trial.J Acquir Immune Defic Syndr 44, no. 2 (February 1, 2007): 203–12. https://doi.org/10.1097/01.qai.0000248356.48501.ff.
Russell ND, Graham BS, Keefer MC, McElrath MJ, Self SG, Weinhold KJ, et al. Phase 2 study of an HIV-1 canarypox vaccine (vCP1452) alone and in combination with rgp120: negative results fail to trigger a phase 3 correlates trial. J Acquir Immune Defic Syndr. 2007 Feb 1;44(2):203–12.
Russell, Nina D., et al. “Phase 2 study of an HIV-1 canarypox vaccine (vCP1452) alone and in combination with rgp120: negative results fail to trigger a phase 3 correlates trial.J Acquir Immune Defic Syndr, vol. 44, no. 2, Feb. 2007, pp. 203–12. Pubmed, doi:10.1097/01.qai.0000248356.48501.ff.
Russell ND, Graham BS, Keefer MC, McElrath MJ, Self SG, Weinhold KJ, Montefiori DC, Ferrari G, Horton H, Tomaras GD, Gurunathan S, Baglyos L, Frey SE, Mulligan MJ, Harro CD, Buchbinder SP, Baden LR, Blattner WA, Koblin BA, Corey L, National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network. Phase 2 study of an HIV-1 canarypox vaccine (vCP1452) alone and in combination with rgp120: negative results fail to trigger a phase 3 correlates trial. J Acquir Immune Defic Syndr. 2007 Feb 1;44(2):203–212.

Published In

J Acquir Immune Defic Syndr

DOI

ISSN

1525-4135

Publication Date

February 1, 2007

Volume

44

Issue

2

Start / End Page

203 / 212

Location

United States

Related Subject Headings

  • Virology
  • Vaccines, Synthetic
  • Vaccines, Subunit
  • T-Lymphocytes, Cytotoxic
  • Neutralization Tests
  • Middle Aged
  • Male
  • Interferon-gamma
  • Humans
  • HIV-1