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

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.

• Authors: H M Feder Jr, J Beran, C Van Hoecke, B Abraham, N De Clercq, C Buscarino, D L Parenti
• Journal: The Journal of pediatrics (J Pediatr) Vol. 135 Issue 5 Pg. 575-9 (Nov 1999) ISSN: 0022-3476 [Print] United States
• PMID: 10547245 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

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

Topics

• 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, immunology, prevention & control)
• Male
• Vaccination