SB Completes Phase III Lyme Disease Vaccine Trial

SmithKline Beecham has completed its first Phase III trial of itscandidate vaccine to prevent Lyme disease, and says it now plans to file for approval in the USA before the end of the year. Meantime, the company has announced plans to develop a different formulation of the vaccine for the European market.

Lyme disease is caused by various strains of the bacteria Borrelia, and is transmitted by the bite of infected ticks. Wooded areas harbor mice and deer infected with the bacteria, and ticks that feed on the infected animals become the vectors which transmit the infection to humans.

SB's US Phase III trial involved over 10,000 vaccinees in New England, the mid-Atlantic region and the Midwest. Results from the study were reviewed by the Data and Safety Monitoring Board, which agreed that the vaccine was effective and recommended that trial participants who previously received placebo should now be offered vaccination; this crossover was a stipulation of the trial protocol. Data from the trial are not yet publicly available but have been submitted to a peer-reviewed journal for publication.