Document Detail

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).
MedLine Citation:
PMID:  9859958     Owner:  NLM     Status:  MEDLINE    
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.
J S Lambert; J McNamara; S L Katz; T Fenton; M Kang; T C VanCott; R Livingston; E Hawkins; J Moye; W Borkowsky; D Johnson; R Yogev; A M Duliege; D Francis; A Gershon; D Wara; N Martin; M Levin; G McSherry; G Smith
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association     Volume:  19     ISSN:  1077-9450     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr. Hum. Retrovirol.     Publication Date:  1998 Dec 
Date Detail:
Created Date:  1998-12-31     Completed Date:  1998-12-31     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  9501482     Medline TA:  J Acquir Immune Defic Syndr Hum Retrovirol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  451-61     Citation Subset:  IM; X    
The Johns Hopkins University, Baltimore, Maryland, USA.
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MeSH Terms
AIDS Vaccines / administration & dosage,  adverse effects,  immunology*
CD4 Lymphocyte Count
Child, Preschool
Cohort Studies
Disease Progression
Double-Blind Method
HIV Envelope Protein gp120 / immunology
HIV Envelope Protein gp160 / immunology
HIV Infections / immunology*,  therapy
Immunoenzyme Techniques
Immunotherapy, Active* / adverse effects
Injections, Intramuscular
Lymphocyte Activation
Vaccines, Synthetic / administration & dosage,  adverse effects,  immunology*
Grant Support
N01-HD-3-3162/HD/NICHD NIH HHS; U0-A1-25883//PHS HHS; U0-A1-27565//PHS HHS
Reg. No./Substance:
0/AIDS Vaccines; 0/HIV Envelope Protein gp120; 0/HIV Envelope Protein gp160; 0/Vaccines, Synthetic

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