Safety and immunogenicity of HIV recombinant envelope vaccines in HIV- infected infants and children

John S. Lambert, James McNamara, Samuel L. Katz, Terry Fenton, Minhee Kang, Thomas C. VanCott, Robert Livingston, Elizabeth Hawkins, Jack Moye, William Borkowsky, Daniel Johnson, Ram Yogev, Ann Marie Duliege, Donald Francis, Anne Gershon, Diane Wara, Natasha Martin, Myron Levin, George McSherry, Gale Smith

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31 Scopus citations


Study objectives were to evaluate the safety and immunogenicity of three HIV recombinant glycoproteins in HIV-infected infants and children between 1 month and 18 years of age with asymptomatic (P-1) infection. Using Chiron rgp 120 (SF-2) 15 or 50 μg; MicroGeneSys rgp 160 (IIIB) 40 or 320 μg; Genentech rgp120 (MN) 75 or 300 μg; or adjuvant control (Alum or MF-59), children were randomized to a double-blind, placebo-controlled, dose-escalating study of vaccine administered intramuscularly at entry and 1, 2, 3, 4, and 6 months later. No adverse events were attributed to study vaccines. Between 30% and 56% of volunteers exhibited a lymphoproliferative response as defined in terms of stimulation index (SI) to vaccine antigens; 65% of vaccinees but none of placebo recipients exhibited moderate or strong responses after enzyme immunoassay to HIV specific antigens. CD4 cell counts and quantitative HIV culture did not differ significantly among vaccine and control groups, nor were differences found among groups in HIV disease progression. The rgp160 and gp120 subunit vaccines were safe and immunogenic in this population.

Original languageEnglish (US)
Pages (from-to)451-461
Number of pages11
JournalJournal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Issue number5
StatePublished - Dec 15 1998

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Virology


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