Lyme Disease Vaccine Brand Name– LYMErix
What is Lyme Disease Vaccine
NOTE: This drug is discontinued in the US.
LYMErix® is the world’s first human vaccine to be approved for prevention of Lyme disease, an infection that is transmitted to humans through bites from the tick vectors Ixodes scapularis and I. pacificus. In 1997 in the US, approximately 10,500 cases of Lyme disease were reported.
LYMErix® is a monovalent vaccine that contains a recombinant protein (OspA) from the outer surface of the spirochete that causes Lyme disease, Borrelia burgdorferi.
LYMErix® was found in clinical trials to prevent definite Lyme disease in 49% of adult patients after 2 doses and 76—86% after 3 doses.
Immulyme®, a second Lyme disease vaccine, has been submitted for FDA approval. Immulyme® is also a monovalent recombinant OspA-based vaccine against Borrelia burgdorferi that is administered in a 3-dose immunization schedule; it appears to have similar efficacy to LYMErix®.
The phase III study of LYMErix® did not enroll elderly patients > 70 years of age. The phase III study of the Immulyme® revealed that the vaccine was not as effective in men over 60 years; it was 100% effective in adult women regardless of age.
Trials of both vaccines only followed patients for 20 months and the duration of immunity provided by the initial Lyme disease vaccination series has been questioned.
Further trials should establish whether booster immunizations will be needed, or if the initial Lyme disease vaccination schedule may be accomplished more rapidly (i.e., in 6 months versus 1 year).
Phase III studies are in progress to determine the safety and efficacy of Lyme disease vaccines in children. In Europe, a vaccine for Lyme disease is in preclinical development; it will be multivalent and include antigens from B. burgdorferi, B. afzelli, and B. garinii. LYMErix® received FDA approval in December 1998 for the prevention of Lyme disease in adolescents and adults 15 years of age and older.
The manufacturer of the LYMErix® vaccine discontinued marketing in February 2002, citing poor sales in the US; safety was not an issue.
- Lyme disease prophylaxis
For Lyme disease prophylaxis (Borrelia burgdorferi prophylaxis)
NOTE: The efficacy of the LYMErix vaccine is dependent on the timing of administration; the 2nd and 3rd doses of the initial vaccination series should occur several weeks prior to the onset of Borrelia transmission season in the geographical area. For example, patients in the northeast region of the US were vaccinated between the months of January and April in clinical trials.
- anaphylactoid reactions
- carpal tunnel syndrome
- injection site reaction
- laboratory monitoring not necessary
- anticoagulant therapy
- AV block
- cardiac disease
- corticosteroid therapy
- human immunodeficiency virus (HIV) infection
- intravenous administration
- latex hypersensitivity
- neoplastic disease
- neurological disease
- neuromuscular disease
- radiation therapy
- respiratory infection
- rheumatoid arthritis