Journal Article

Safety of 2 Recombinant Human Immunodeficiency Virus Type 1 (HIV-1) Envelope Vaccines in Neonates Born to HIV-1-Infected Women

Coleen K. Cunningham, Diane W. Wara, Minhee Kang, Terry Fenton, Elizabeth Hawkins, James McNamara, Lynne Mofenson, Ann Marie Duliege, Donald Francis, Elizabeth J. McFarland and William Borkowsky

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 32, issue 5, pages 801-807
Published in print March 2001 | ISSN: 1058-4838
Published online March 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/319215
Safety of 2 Recombinant Human Immunodeficiency Virus Type 1 (HIV-1) Envelope Vaccines in Neonates Born to HIV-1-Infected Women

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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.

Journal Article.  4357 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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