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Notice to Readers Availability of Lyme Disease Vaccine

On December 21, 1998, the Food and Drug Administration (FDA) licensed LYMErixTM (SmithKline Beecham Biologicals, Reixensart, Belgium), * a new vaccine against Lyme disease (LD). This report summarizes information about this vaccine and provides epidemiologic information about LD relevant to vaccine use.

Each dose of LYMErixTM contains 30 ug of lipidated recombinant outer surface protein A (OspA) of Borrelia burgdorferi sensu stricto, the causative agent of LD in North America, adsorbed onto aluminum adjuvant (1). It is indicated for use in persons aged 15-70 years (1). Three doses of the vaccine are administered by intramuscular injection. The initial dose is followed by a second dose 1 month later and a third dose 12 months after the first. Vaccine administration should be timed so the second dose and the third dose are given several weeks before the beginning of the B. burgdorferi transmission season (1), which usually begins in April. In a randomized, double-blind, multicenter trial involving 10,936 participants living in areas of the northeastern and upper north central United States where LD is endemic, the vaccine efficacy in preventing LD was 50% (95% confidence interval {CI}=14%-71%) after the first two doses and 78% (95% CI=59%-88%) after three doses (1). Efficacy against asymptomatic seroconversion was 83% (95% CI=25%-96%) after two doses and 100% (95% CI=30%-100%) after three doses (1). The duration of immunity following the three-dose vaccination series is unknown, and the need for booster doses has not been determined.

Local reactions at the site of injection were reported by significantly more vaccine recipients than placebo recipients (1). Unsolicited reports of myalgia, influenza-like illness, fever, and chills within 30 days after a dose were significantly more common among vaccine recipients than placebo recipients, but none of these were reported by greater than 5% of either group (1). Reports of arthritis were not significantly different between vaccine and placebo recipients, but vaccine recipients reported significantly more transient arthralgia and myalgia following each dose of vaccine (1).

LD is the most commonly reported vectorborne disease in the United States. Since the implementation of a standardized surveillance case definition in 1991, greater than 90% of cases have been reported from the northeast and north central states (Figure_1) (2). Persons of all ages are susceptible to infection, but the highest reported rates of LD occur in children aged less than 15 years and adults aged 30-59 years. Transmission peaks from April through July, when the nymphal stages of the tick vectors of LD, Ixodes scapularis and I. pacificus, are actively seeking hosts. These ticks are found primarily in leaf litter and low-lying vegetation in wooded, brushy, or overgrown grassy areas and can transmit other diseases such as babesiosis and ehrlichiosis (3,4).

An estimated 85% of persons with symptomatic LD have the characteristic rash, erythema migrans (5). Untreated infection can cause arthritis or neurologic symptoms, such as radiculoneuropathy or encephalopathy. At any stage, the disease can usually be successfully treated with standard antibiotic regimens.

Strategies to prevent LD include avoiding tick habitats, wearing protective clothing, using repellents to avoid tick attachment, promptly removing attached ticks, and employing community measures to reduce tick abundance (6). Because the vaccine is less than 100% efficacious and does not provide protection against other tickborne illnesses, vaccination should not be considered a substitute for other preventive measures.

LD vaccine should be targeted to persons at risk for exposure to infected vector ticks. This risk can be assessed by considering the focal geography of LD and the extent to which a person's activities place him or her in contact with ticks (2). Vaccination of persons with frequent or prolonged exposure to ticks in areas endemic for LD is likely to be an important preventive strategy (7). For persons with only brief or intermittent exposure to tick habitat in areas where LD is endemic, the public health benefits of vaccination, compared with early diagnosis and treatment of LD, are not clear (7) . Recommendations for use of LD vaccine are being developed by the Advisory Committee for Immunization Practices.

Reported by: Div of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, CDC.

References

  1. SmithKline Beecham Biologicals. LYMErixTM product label. Reixensart, Belgium: SmithKline Beecham Biologicals, December 1998.
  2. Dennis DT. Epidemiology, ecology, and prevention of Lyme disease. In: Rahn DW, Evans J, eds. Lyme disease. Philadelphia: American College of Physicians, 1998;7-34.
  3. Spielman A, Wilson ML, Levine JF, et al. Ecology of Ixodes dammini-borne human babesiosis and Lyme disease. Annu Rev Entomol 1985;30:439-60.
  4. Des Vignes F, Fish D. Transmission of the agent of human granulocytic ehrlichiosis by host-seeking Ixodes scapularis (Acari:Ixodidae) in southern New York state. J Med Entomol 1997;34:379-82.
  5. Nadelman RB, Wormser GP. Lyme borreliosis. Lancet 1998;352:557-65.
  6. Piesman J, Gray JS. Lyme disease/Lyme borreliosis. In: Sonenshine DR, Mather TN, eds. Ecological dynamics of tick-borne zoonoses. New York: Oxford University Press, 1994:327-50.
  7. Hayes EB, Dennis DT. Immunization against Lyme disease {Letter}. N Engl J Med 1998;339:1637.

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