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Analysis of Intercurrent Human Immunodeficiency Virus Type 1 Infections in Phase I and II Trials of Candidate AIDS Vaccines


Journal Article

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.; ,

J Infec Dis




Adult; AIDS Vaccines; Amino Acid Sequence; CD4 Lymphocyte Count; Female; HIV Antibodies; HIV Envelope Protein gp120; HIV Infections; HIV-1; Immunity- Active; Incidence Male; Middle Aged; Molecular Sequence Data; Neutralization Tests; Peptide Fragments

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 (> or = 3 injections), and 6 were partially immunized (< or = 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.

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