Analysis of intercurrent human immunodeficiency virus type 1 infections in phase I and II trials of candidate AIDS vaccines

Barney S. Graham*, M. Juliana McElrath, Ruth I. Connor, David H. Schwartz, Geoffrey J. Gorse, Michael C. Keefer, Mark J. Mulligan, Thomas J. Matthews, Steven M. Wolinsky, David C. Montefiori, Sten H. Vermund, John S. Lambert, Lawrence Corey, Robert B. Belshe, Raphael Dolin, Peter F. Wright, Bette T. Korber, Mark C. Wolff, Patricia E. Fast

*Corresponding author for this work

Research output: Contribution to journalArticle

75 Scopus citations

Abstract

Among 2099 uninfected subjects in phase I and II trials of candidate AIDS vaccines, 23 were diagnosed with intercurrent human immunodeficiency virus type 1 (HIV-1) infection. High-risk sexual exposures accounted for 17 infections, and intravenous drug use accounted for 6. Four subjects received placebo, 13 received a complete immunization schedule (≤3 injections), and 6 were partially immunized (≤2 injections). There was no significant difference between vaccine recipients and control groups in incidence of HIV- 1 infection, virus load, CD4 lymphocyte count, or V3 loop amino acid sequence. In summary, 19 vaccinated subjects acquired HIV-1 infection during phase I and II trials, indicating that immunization with the products described is <100% effective in preventing or rapidly clearing infection. Laboratory analysis suggested that vaccine-induced immune responses did not significantly affect the genotypic or phenotypic characteristics of transmitted virus or the early clinical course of HIV-1 infection.

Original languageEnglish (US)
Pages (from-to)310-319
Number of pages10
JournalJournal of Infectious Diseases
Volume177
Issue number2
DOIs
StatePublished - Jan 1 1998

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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    Graham, B. S., McElrath, M. J., Connor, R. I., Schwartz, D. H., Gorse, G. J., Keefer, M. C., Mulligan, M. J., Matthews, T. J., Wolinsky, S. M., Montefiori, D. C., Vermund, S. H., Lambert, J. S., Corey, L., Belshe, R. B., Dolin, R., Wright, P. F., Korber, B. T., Wolff, M. C., & Fast, P. E. (1998). Analysis of intercurrent human immunodeficiency virus type 1 infections in phase I and II trials of candidate AIDS vaccines. Journal of Infectious Diseases, 177(2), 310-319. https://doi.org/10.1086/514209