Feder Vaccines
Feder- Vaccine Related
J Pediatr. 1999 Nov;135(5):575-9.
Immunogenicity of a recombinant Borrelia burgdorferi outer surface protein A vaccine against Lyme disease in children.
Feder HM Jr, Beran J, Van Hoecke C, Abraham B, De Clercq N, Buscarino C, Parenti DL.
Department of Family Medicine, University of Connecticut Health Center, Farmington, Connecticut 06030-1406, USA.
Comment in:
Abstract
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.
PMID: 10547245 [PubMed - indexed for MEDLINE]
Pediatrics. 2000 Jun;105(6):1333-4.
Lyme disease vaccine: good for dogs, adults, and children?
Departments of Pediatrics and Family Medicine, Connecticut Children's Medical Center, Hartford, CT 06106, USA.
PMID: 10835077 [PubMed - indexed for MEDLINE]