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.
Indications
- 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.
Mechanism of Action of Lyme Disease Vaccine
Recombinant Lyme disease vaccine imparts immunity against Borrelia borgdorferi by stimulating production of antibodies to OspA.
OspA is only 1 of 105 lipoproteins identified in the genome of the Borrelia burgdorferi spirochete.
The mechanism of the Lyme disease vaccine is thought to involve antibody-mediated killing of the spirochete in the tick.
The anti-OspA IgG antibody appears to enter the gut of the tick while the tick is feeding on the blood of an immunized host and kill the spirochete even before transmission occurs.
Bacteriocidal activity against the spirochete has been correlated to levels of OspA (LA-2-equivalent) antibody in the immunized host.
There are concerns that a Lyme disease vaccine that contains only a single surface antigen would not be protective against multiple strains of B. burgdorferi.
However, the Lyme disease vaccines have prevented disease in ten separate states (in the US), suggesting that the vaccines provide protection against different strains of the spirochete.
Side Effects
- anaphylactoid reactions
- arthralgia
- carpal tunnel syndrome
- chills
- erythema
- fever
- injection site reaction
- myalgia
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- anticoagulant therapy
- AV block
- breast-feeding
- cardiac disease
- children
- coagulopathy
- corticosteroid therapy
- fever
- geriatric
- human immunodeficiency virus (HIV) infection
- hypogammaglobulinemia
- immunosuppression
- infants
- intravenous administration
- latex hypersensitivity
- leukemia
- lymphoma
- neonates
- neoplastic disease
- neurological disease
- neuromuscular disease
- pregnancy
- radiation therapy
- respiratory infection
- rheumatoid arthritis
- thrombocytopenia
Interactions
- Ocrelizumab
- Siponimod
