Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

To determine the safety of 2 candidate vaccines against human immunodeficiency virus type 1 (HIV-1), a randomized, placebo-controlled, multicenter trial compared low, medium, and high doses of the vaccines or an adjuvant among infants born to HIV-infected women. No local or systemic reactions of grade 2 or greater were reported 48 h after the subjects underwent immunization. Grade 3 or 4 chemistry toxicities occurred in 5 (3%) and grade 3 or 4 hematologic toxicities in 17 (11%) of 154 vaccinated subjects (not significantly different from 29 adjuvant recipients). CD4(+) cell percentages of < or = 20% occurred at least once in 9 vaccinated subjects and 1 control subject. Sustained CD4(+) cell percentages of < or = 20% occurred in 4 HIV-infected children. Fourteen infants (8%) were confirmed to be HIV-infected; median CD4(+) cell counts among these children were 2074, 1674, 1584, and 821 cells/mm(3) at birth and weeks 24, 52, and 104, respectively. Thus, both vaccines were safe and well tolerated in neonates, and there was no evidence of accelerated immunologic decline in HIV-infected infants.

Full Text

Duke Authors

Cited Authors

  • Cunningham, CK; Wara, DW; Kang, M; Fenton, T; Hawkins, E; McNamara, J; Mofenson, L; Duliege, AM; Francis, D; McFarland, EJ; Borkowsky, W; Pediatric AIDS Clinical Trials Group 230 Collaborators,

Published Date

  • March 1, 2001

Published In

Volume / Issue

  • 32 / 5

Start / End Page

  • 801 - 807

PubMed ID

  • 11229849

International Standard Serial Number (ISSN)

  • 1058-4838

Digital Object Identifier (DOI)

  • 10.1086/319215


  • eng

Conference Location

  • United States