Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. National Institutes of Health-sponsored Pediatric AIDS Clinical Trials Group (ACTG-218).
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 microg; MicroGeneSys rgp 160 (IIIB) 40 or 320 microg; Genentech rgp120 (MN) 75 or 300 microg; 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.
Lambert
J S
JS
The Johns Hopkins University, Baltimore, Maryland, USA. lambert@umbi.umd.edu
McNamara
J
J
Katz
S L
SL
Fenton
T
T
Kang
M
M
VanCott
T C
TC
Livingston
R
R
Hawkins
E
E
Moye
J
J
Borkowsky
W
W
Johnson
D
D
Yogev
R
R
Duliege
A M
AM
Francis
D
D
Gershon
A
A
Wara
D
D
Martin
N
N
Levin
M
M
McSherry
G
G
Smith
G
G
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D000293:Adolescent; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D015699:HIV Envelope Protein gp120 / Q000276:immunology; D019302:HIV Envelope Protein gp160 / Q000276:immunology; D015658:HIV Infections / Q000276:immunology* / Q000628:therapy; D006801:Humans; D007124:Immunoenzyme Techniques; D016233:Immunotherapy, Active / Q000009:adverse effects; D007223:Infant; D007273:Injections, Intramuscular; D008213:Lymphocyte Activation; D008297:Male; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
D016915:AIDS Vaccines; D015699:HIV Envelope Protein gp120; D019302:HIV Envelope Protein gp160; D014614:Vaccines, Synthetic