The Lyme Disease Network
Medical / Scientific Abstract
|Title:||Immunogenicity of a recombinant Borrelia burgdorferi outer surface protein A vaccine against Lyme disease in children [see comments]|
|Authors:||Feder HM Jr, Beran J, Van Hoecke C, Abraham B, De Clercq N, Buscarino C, Parenti DL|
|Source:||J Pediatr 1999 Nov;135(5):575-9|
|Organization:||Department of Family Medicine, University of Connecticut Health Center, Farmington, Connecticut 06030-1406, USA.|
BACKGROUND AND OBJECTIVE: A recombinant lipoprotein vaccine against Lyme disease, containing 30 microg of Borrelia burgdorferi outer surface protein A (OspA) with aluminum adjuvant, has been shown in a large US field trial of subjects >/=15 years of age to offer 76% efficacy against clinical Lyme disease after 3 injections given at 0, 1, and 12 months. Lyme disease is also an important problem in children; thus, OspA vaccine trials in children are needed. The purpose of this study was to investigate the safety and immunogenicity of 2 different doses of lipoprotein OspA with aluminum adjuvant vaccine in healthy children 5 to 15 years of age in a double-blind, randomized study. STUDY DESIGN: In a double-blind study, 250 children from the Czech Republic were randomly assigned to receive 15 microg or 30 microg of OspA vaccine at 0, 1, and 2 months. Serum samples, obtained before vaccination and 1 month after the second and third doses, were analyzed for antiOspA antibody. Solicited and unsolicited symptoms were collected from diary cards. RESULTS: Local pain at the injection site was reported by approximately 76% of the 250 children. Headaches (after 5% to 18% of the injections) and malaise (after 2% to 16% of the injections) were the most frequently reported general symptoms. Local and generalized symptoms were not different between the 15 microg and 30 microg groups, and all symptoms resolved within 4 days. Both doses were highly immunogenic, with the 30 microg dose eliciting higher antibody levels. Seroconversion occurred in 99% of the 250 children. CONCLUSIONS: The OspA vaccine against Lyme disease was well tolerated and highly immunogenic in children.
Adolescence, Animal, Antigens, Surface, IMMUNOLOGY, Bacterial Outer Membrane Proteins, IMMUNOLOGY, Bacterial Vaccines, ADMINISTRATION & DOSAGE, Borrelia burgdorferi, IMMUNOLOGY, Child, Child, Preschool, Double-Blind Method, Enzyme-Linked Immunosorbent Assay, Female, Human, Immunization Schedule, Lyme Disease, EPIDEMIOLOGY, IMMUNOLOGY, PREVENTION & CONTROL, Male, Vaccination
Unique ID: 20015037
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