Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women.
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.
Cunningham
C K
CK
Department of Pediatrics, State University of New York, Upstate Medical University, Syracuse, NY 13210, USA. cunningc@mail.upstate.edu
Wara
D W
DW
Kang
M
M
Fenton
T
T
Hawkins
E
E
McNamara
J
J
Mofenson
L
L
Duliege
A M
AM
Francis
D
D
McFarland
E J
EJ
Borkowsky
W
W
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000235:genetics; D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D015699:HIV Envelope Protein gp120 / Q000235:genetics / Q000276:immunology*; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects
D016915:AIDS Vaccines; D000276:Adjuvants, Immunologic; D015699:HIV Envelope Protein gp120; C089950:MF59 oil emulsion; D011136:Polysorbates; D014614:Vaccines, Synthetic; D013185:Squalene