LYMErix [Lyme Disease Vaccine (Recombinant OspA)] is a noninfectious recombinant vaccine developed and manufactured by Smith Kline Beecham Biologicals. The causative agent of Lyme disease is Borrelia burgdorferi; in North America, all Lyme disease is due to Borrelia burgdorferi sensu stricto. The vaccine contains lipoprotein OspA, an outer surface protein of Borrelia burgdorferi sensu stricto ZS7, as expressed by Escherichia coli. Lipoprotein OspA is a single polypeptide chain of 257 amino acids with lipids covalently bonded to the N terminus. No substance of animal origin is used in the commercial manufacturing process. Fermentation media consist primarily of inorganic salts, and vitamins, with small quantities of antifoam (contains silicon), kanamycin sulfate (an aminoglycoside antibiotic), and yeast extract. Silicon and kanamycin are removed to levels below detection (<7 ppm and <10 ppb, respectively). The vaccine is adsorbed onto aluminum hydroxide.
LYMErix (lipoprotein outer surface a vaccine) is supplied as a sterile suspension in single-dose vials and prefilled syringes for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration to ensure a uniform turbid white suspension.
Each 0.5 mL dose of vaccine consists of 30 mcg of lipoprotein OspA adsorbed onto 0.5 mg aluminum as aluminum hydroxide adjuvant. Each dose of the vaccine preparation contains 10 mM phosphate buffered saline and 2.5 mg of 2-phenoxyethanol, a bacteriostatic agent.
The potency of the vaccine is evaluated by immunizing mice with LYMErix (lipoprotein outer surface a vaccine) and measuring their serum antibody response to OspA by ELISA.
Last reviewed on RxList: 7/31/2008
This monograph has been modified to include the generic and brand name in many instances.