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

C. K. Cunningham, D. W. Wara, M. Kang, T. Fenton, E. Hawkins, J. McNamara, L. Mofenson, A. M. Duliege, D. Francis, E. J. McFarland, W. Borkowsky, T. Hastings, N. Deygoo, M. Lugo, M. Rivera, K. Contello, S. Nachman, M. Davi, C. R. Salbenblatt, M. J. LevinR. Galvin, M. Mirochnick, A. Dorenbaum, S. A. Spector, W. M. Dankner, L. Frenkel, A. J. Melvin, K. M. Mohan, K. Mooney, C. Vincent, M. Silio, E. McBride, J. Pitt, P. LaRussa, E. G. Chadwick, D. F. Cloutier, J. Lambert, N. Hutton, B. Murante, S. Laverty, J. Sullivan, K. Luzuriaga, R. McKinney, M. Valentine, W. T. Shearer, M. Doyle

Research output: Contribution to journalArticlepeer-review

69 Scopus citations


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 20% occurred at least once in 9 vaccinated subjects and 1 control subject. Sustained CD4+ cell percentages of 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/mm3 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.

Original languageEnglish (US)
Pages (from-to)801-807
Number of pages7
JournalClinical Infectious Diseases
Issue number5
StatePublished - Mar 1 2001

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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