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

J Pediatr. 1999 Nov;135(5):575-9. doi: 10.1016/s0022-3476(99)70055-7.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Animals
  • Antigens, Surface / immunology*
  • Bacterial Outer Membrane Proteins / immunology*
  • Bacterial Vaccines* / administration & dosage
  • Borrelia burgdorferi Group / immunology*
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Immunization Schedule
  • Lipoproteins*
  • Lyme Disease / epidemiology
  • Lyme Disease / immunology
  • Lyme Disease / prevention & control*
  • Male
  • Vaccination

Substances

  • Antigens, Surface
  • Bacterial Outer Membrane Proteins
  • Bacterial Vaccines
  • Lipoproteins
  • OspA protein