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Vaccines for Lyme Disease

Lyme disease has become the most common tick-borne disease in the U.S. Its diverse clinical manifestations, the difficulty of making a definitive diagnosis, and its potential chronicity all amplify its public health importance. An effective preventive measure would be of great benefit to populations living in the endemic regions of the etiologic agent, Borrelia burgdorferi. Fortunately, two groups have now reported that vaccines based on the B. burgdorferi outer surface lipoprotein A (OspA) can protect against Lyme disease.

Steere et al. performed a 2-year, multicenter, double-blind, placebo-controlled trial of a recombinant full-length OspA vaccine given at baseline, 1, and 12 months. The trial enrolled 10,936 subjects aged 15 to 70 years who were living in endemic areas. The vaccine and placebo groups differed only in a slightly larger number of vaccine recipients missing the 1-month injection (p=0.045). The vaccine efficacy for definite Lyme disease was 49% (95% CI, 15% to 69%) in the first year and 76% (95% CI, 58% to 68%) in the second. The vaccine was comparably effective in preventing asymptomatic seroconversion. There was a significant incidence of injection site soreness and erythema and short-term myalgias, fever, and flu-like symptoms, but no prolonged sequelae.

Sigal et al. performed a similarly designed 2-year trial of a different recombinant OspA vaccine also given at baseline, 1, and 12 months. This trial enrolled 10,305 subjects at least 18 years of age; the study and control populations were well matched. The overall protective efficacy of this vaccine was 68% (95% CI, 36% to 85%) in the first year and 92% (95% CI, 69% to 97%) in the second. This vaccine was also associated with significant injection site tenderness during the first 7 days, but not with more persistent adverse effects.

Comment: These vaccines are a major advance in preventing Lyme disease in adults. They appear to protect by inducing levels of antibody to B. burgdorferi OspA that kill the spirochete within the tick during feeding or shortly after inoculation into the host. Booster immunizations will probably be necessary to maintain protective antibody levels. OspA has recently been found to have an epitope that is cross-reactive with a host protein (see following summary); whether this will affect the safety of booster immunizations is not known.

— R Ellison

Published in Journal Watch Infectious Diseases September 1, 1998

Citation(s):

Steere AC et al. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. N Engl J Med 1998 Jul 23 339 209-215.

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Sigal LH et al. A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease. N Engl J Med 1998 Jul 23 339 216-222.

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Steigbigel RT and Benach JL. Immunization against Lyme disease -- an important first step. N Engl J Med 1998 Jul 23 339 263-264.

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