Analysis of intercurrent human immunodeficiency virus type 1 infections in phase I and II trials of candidate AIDS vaccines. AIDS Vaccine Evaluation Group, and the Correlates of HIV Immune Protection Group.

Graham BS, McElrath MJ, Connor RI, Schwartz DH, Gorse GJ, Keefer MC, Mulligan MJ, Matthews TJ, Wolinsky SM, Montefiori DC, Vermund SH, Lambert JS, Corey L, Belshe RB, Dolin R, Wright PF, Korber BT, Wolff MC, Fast PE
J Infect Dis. 1998 177 (2): 310-9

PMID: 9466516 · DOI:10.1086/514209

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.

MeSH Terms (21)

Adult AIDS Vaccines Amino Acid Sequence CD4 Lymphocyte Count Female HIV-1 HIV Antibodies HIV Envelope Protein gp120 HIV Infections Humans Immunity, Active Incidence Male Middle Aged Molecular Sequence Data Neutralization Tests Peptide Fragments Risk-Taking Sequence Analysis Substance Abuse, Intravenous Viral Load

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