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LYMErix(R) Found Immunogenic, Well Tolerated In Children.(Brief Article)

Vaccine Weekly

| August 08, 2001 | COPYRIGHT 2001 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2001 AUG 8 - (NewsRx.com & NewsRx.net) --

by N.R. Saltmarsh, staff medical writer - A recombinant vaccine comprising the outer surface protein A (OspA) of Borrelia burgdorferi (LYMErix(R)) generates antibody levels in children three times those of vaccinated adults, researchers in the United States have found.

The vaccine, which is generally safe and well-tolerated in this age group, is likely to protect against Lyme disease (LD), said V.K. Sikand and colleagues at Tufts University, Boston.

They randomized children four to 18 years old living in Lyme endemic areas to receive either 30 (micro)g of LD vaccine (n=3,063) or placebo (n=1,024) at baseline, one, and 12 months. Immunogenicity results were compared with those of adults receiving the same vaccine in a previous study.

Vaccine recipients had a higher incidence of injection site and systemic reactions compared with placebo recipients, but the majority of events lasted only two to three days and were not severe, reported Sikand and coworkers.

Among the subset of 301 LYMErix vaccinated children for whom immunogenicity was evaluated, the total immunoglobulin G (IgG) anti-OspA geometric mean titer (GMT) at month 13 was statistically higher than the GMT in the adult cohort at month 13 (27,485 enzyme-linked immunosorbent assay units [EL.U]/mL vs. 8,216 EL.U/mL), noted Sikand et al.

All of the pediatric vaccine recipients attained antibody concentrations of at least the proposed seroprotective level of 1400 EL.U/mL. By comparison, 90% of adults attained levels >=1400 EL.U/mL ("Safety and immunogenicity of a recombinant Borrelia ...

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