Immunogenicity of a recombinant Borrelia burgdorferi outer surface protein A vaccine against Lyme disease in children

Background and Objective: A recombinant lipoprotein vaccine against Lyme disease, containing 30 mu g of Borrelia burgdorferi outer surface protein A (OspA) with aluminum adjuvant, has been shown in a large US field trial of subjects greater than or equal to 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 mu g or 30 mu g of OspA vaccine at 0, I, and 2 months. Serum samples, obtained before vaccination and 1 month after the second and third doses, were analyzed for anti-OspA 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 mu g and 30 mu g groups, and all symptoms resolved within 4 days. Both doses were highly immunogenic, with the 30 mu g 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.