Analysis of Intercurrent Human Immunodeficiency Virus Type 1 Infections in Phase I and II Trials of Candidate AIDS Vaccines
02/1998
Journal Article
Authors:
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.;
,
Secondary:
J Infec Dis
Volume:
177
Pagination:
310-319
URL:
http://www.ncbi.nlm.nih.gov/pubmed/9466516
Keywords:
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
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 (> 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.
