LYME DISEASE vaccine does not protect all recipients against infection with B. burgdorferi and offers no protection against other tickborne diseases. Vaccinated persons should continue to practice personal protective measures against ticks and should seek early diagnosis and treatment of suspected tickborne infections. Because Lyme disease is not transmitted person-to-person, use of the vaccine will not reduce risk among unvaccinated persons. Decisions regarding the use of vaccine should be based on individual assessment of the risk for exposure to infected ticks and on careful consideration of the relative risks and benefits of vaccination compared with other protective measures, including early diagnosis and treatment of Lyme disease. The risk for Lyme disease is focally distributed in the United States. Detailed information regarding the distribution of Lyme disease risk within specific areas is best obtained from state and local public health authorities.
The following recommendations are made regarding use of Lyme disease vaccine:
• Lyme disease vaccination should be considered for persons aged 15-70 years who engage in activities (e.g., recreational, property maintenance, occupational, or leisure) that result in frequent or prolonged exposure to tick-infested habitat.
• Lyme disease vaccination may be considered for persons aged 15-70 years who are exposed to tick-infested habitat but whose exposure is neither frequent nor prolonged. The benefit of vaccination beyond that provided by basic personal protection and early diagnosis and treatment of infection is uncertain.
• Lyme disease vaccination is not recommended for persons who have minimal or no exposure to tick-infested habitat.
• Lyme disease vaccination is not recommended for persons who reside, work, or recreate in areas of low or no risk.
• Because of the limited time of exposure, travelers to Lyme disease-endemic areas within the United States are generally expected to be at lower risk for Lyme disease than those who permanently reside in endemic areas. Vaccination should be considered for travelers to areas of high risk if frequent or prolonged exposure to tick habitat is anticipated.
Travelers can obtain some protection from two doses of vaccine but will not achieve optimal protection until the full series of three doses has been administered. All travelers to high- or moderate-risk areas during Lyme disease transmission season should practice personal protection measures as described earlier and seek prompt diagnosis and treatment if signs or symptoms of Lyme disease develop. Lyme disease is endemic in some temperate areas of Europe and Asia; however, considerable heterogeneity of expression exists in the Eurasian strains of B. burgdorferi sensu lato that infect humans, and whether the rOspA vaccine licensed for use in the United States would protect against infection with Eurasian strains is uncertain.
• Until the safety and immunogenicity of rOspA vaccines in children have been established, this vaccine is not recommended for children aged <15 years. Currently, LYMErix is licensed for use in persons aged 15-70 years only.
• The safety and efficacy of LYMErix have not been established for persons aged >70 years. LYMErix is licensed for use in persons aged 15-70 years only.
• Because the safety of rOspA vaccines administered during pregnancy has not been established, vaccination of women who are known to be pregnant is not recommended.
No evidence exists that pregnancy increases the risk for Lyme disease or its severity. Acute Lyme disease during pregnancy responds well to antibiotic therapy, and adverse fetal outcomes have not been reported in pregnant women receiving standard courses of treatment. A vaccine pregnancy registry has been established by SmithKline Beecham Pharmaceuticals. In the event that a pregnant woman is vaccinated, health-care providers are encouraged to register this vaccination by calling, toll-free, (800) 366-8900, ext. 5231.
• Persons with immunodeficiency were excluded from the Phase III safety and efficacy trial, and no data are available regarding Lyme disease vaccine use in this group.
• Persons with diseases associated with joint swelling (including rheumatoid arthritis) or diffuse musculoskeletal pain were excluded from the Phase III safety and efficacy trial, and only limited data are available regarding Lyme disease vaccine use in such patients.
• Vaccination should be considered for persons with a history of previous uncomplicated Lyme disease who are at continued high risk.
• Persons who have treatment-resistant Lyme arthritis should not be vaccinated because of the association between this condition and immune reactivity to OspA.
• Persons with chronic joint or neurologic illness related to Lyme disease, as well as second- or third-degree atrioventricular block, were excluded from the Phase III safety and efficacy trial, and thus, the safety and efficacy of Lyme disease vaccine in such persons are unknown.
• Three doses of the vaccine should be administered by intramuscular injection. The initial dose should be followed by a second dose 1 month later and a third dose 12 months after the first dose. Vaccine administration should be timed so that the second dose of the vaccine (year 1) and the third dose (year 2) are administered several weeks before the beginning of the B. burgdorferi transmission season, which usually begins in April.
• Whether protective immunity will last longer than 1 year beyond the month-12 dose is unknown. Data regarding antibody levels during a 20-month period after the first injection of LYMErix indicate that boosters beyond the month-12 booster might be necessary (see Immunogenicity). Additional data are needed before recommendations regarding vaccination with more than three doses of rOspA vaccine can be made.
• The safety and efficacy of the simultaneous administration of rOspA vaccine with other vaccines have not been established. If LYMErix must be administered concurrently with other vaccines, each vaccine should be administered in a separate syringe at a separate injection site.
Recommendations for the Use of Lyme Disease Vaccine. Arch Dermatol. 1999;135(11):1425-1426. doi:10-1001/pubs.Arch Dermatol.-ISSN-0003-987x-135-11-dmm1199