Vaccine

Active immunization against Lyme disease in individuals between 15-70 years of age. Individuals most at risk are those who live, work, or travel to B. burgdorferi-infected, tick-infested, grassy/wooded areas.

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It is not known whether Lyme disease vaccine is excreted in human milk. Because many drugs are excreted in milk, caution should be exercised when the vaccine is given to nursing mothers. Healthcare professionals are encouraged to register pregnant women who receive the vaccine with the SKB vaccination pregnancy registry (1-800-366-8900, ext 5231).

Known hypersensitivity to any component of the vaccine. Vaccination should be postponed during acute moderate to severe febrile illness (minor illness is generally not a contraindication). Safety and efficacy in patients <15 years of age have not been established.

Do not administer to patients with treatment-resistant Lyme arthritis. Will not prevent disease in patients with prior infection and offers no protection against other tick-borne diseases. Immunosuppressed patients or those receiving immunosuppressive therapy (vaccine may not be effective) - defer vaccination until 3 months after therapy. Avoid in patients receiving anticoagulant therapy (due to intramuscular injection). The physician should take all known precautions for prevention of allergic or other reactions. Administer with caution to patients with known or suspected latex allergy (applies only to the LMErix Tip-Lok™ syringe, vaccine vial does not contain natural rubber). Duration of immunity has not been established.

(Limited to overall self-reported events occurring within 30 days following a dose)

1% to 10%:

Central nervous system: Headache (5.6%), fatigue (3.9%), fever (2.6%), chills (2%), dizziness (1%)

Dermatologic: Rash (1.4%)

Gastrointestinal: Nausea (1.1%)

Neuromuscular & skeletal: Arthralgia (6.8%), myalgia (4.8%), muscle aches (2.8%), back pain (1.9%), stiffness (1%)

Respiratory: Upper respiratory tract infection (4.4%), sinusitis (3.2%), pharyngitis (2.5%), rhinitis (2.4%), cough (1.5%), bronchitis (1.1%)

Miscellaneous: Viral infection (2.8%), flu-like syndrome (2.5%)

Solicited adverse event rates were higher than unsolicited event rates (above). These included local reactions of soreness (93.5%), redness (41.8%), and swelling (29.9%). In addition, general systemic symptoms included fatigue (40.8%), headache (38.6%), arthralgia (25.6%), rash (11.7%), and fever (3.5%)

Patients with a history of Lyme disease were noted to experience a higher frequency of early musculoskeletal reactions. Other differences in the observed rate of adverse reactions were not significantly different between vaccine and placebo recipients.

No data available

Store between 2°C and 8°C (36°F and 46°F)

Lyme disease vaccine is a recombinant, noninfectious lipoprotein (OspA) derived from the outer surface of Borrelia burgdorferi, the causative agent of Lyme disease. Vaccination stimulates production of antibodies directed against this organism, including antibodies against the LA-2 epitope, which have bactericidal activity. Since OspA expression is down-regulated after inoculation into the human host, at least part of the vaccine's efficacy may be related to neutralization of bacteria within the midgut of the tick vector, preventing transmission to the human host.

Adults: I.M.: Vaccination with 3 doses of 30 mcg (0.5 mL), administered at 0, 1, and 12 months, is recommended for optimal protection

Intramuscular injection into the deltoid region is recommended. Do not administer intravenously, intradermally, or subcutaneously. The vaccine should be used as supplied without dilution.

Vaccination will result in a positive B. burgdorferi IgG via ELISA (Western blot testing is recommended)

No information available to require special precautions

No effects or complications reported

You will require two more injections over the next 12 months; schedule appointments for those injections as directed by prescriber. You may experience headache, mild nausea, chills, fever, or dizziness following injection. These should subside, if not contact prescriber. Report persistent redness, swelling, or pain at injection site; skin rash; persistent flu-like symptoms; or muscle aches of stiffness. Pregnancy/breast-feeding precautions: Inform prescriber is you are or intend to be pregnant. Consult prescriber if breast-feeding.

Injection:

Prefilled syringe (Tip-Lok™): 30 mcg/0.5 mL

Sigal LH, Zahradnik JM, Lavin P, et al, "A Vaccine Consisting of Recombinant Borrelia burgdorferi Outer-Surface Protein A to Prevent Lyme Disease," N Engl J Med, 1998, 339(4):216-22.

Steere AC, Sikand VK, Meurice F, et al, "Vaccination Against Lyme Disease With Recombinant Borrelia burgdorferi Outer-Surface Lipoprotein A With Adjuvant," N Engl J Med, 1998, 339(4):209-15.

Wormser GP, "Lyme Disease Vaccine," Infection, 1996, 24(2):203-7.