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.

Publication Type
Journal Article
Year of Publication
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
J Infect Dis
Date Published
1998 Feb
Adult; AIDS Vaccines; Amino Acid Sequence; CD4 Lymphocyte Count; Female; HIV Antibodies; HIV Envelope Protein gp120; HIV Infections; HIV-1; Humans; Immunity, Active; Incidence; Male; Middle Aged; Molecular Sequence Data; Neutralization Tests; Peptide Fragments; Risk-Taking; Sequence Analysis; Substance Abuse, Intravenous; Viral Load

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.