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  Lyme Borreliosis Vaccine

Lyme borreliosis is a tick-transmitted, bacterial infection caused by spirochetes belonging to the Borrelia burgdorferi sensu lato group. This infection is the most common tick-borne disease in Europe and the United States, afflicting tens of thousands of individuals each year (1,2). After an initial infection, which is localized to the site of the tick bite, and commonly characterized by the formation of an expanding red rash (erythema migrans), the bacteria may spread to other sites in the body. Secondary sites of infection may include the nervous system, joints and heart and may lead to severe neurological complications, chronic arthritis and potentially life threatening perturbations to heart function (3). Effective disease prevention is critical, since antibiotic therapy is not always effective and symptoms may persist after treatment (4).

Currently, there is no vaccine for the prevention of human Lyme borreliosis. However, vaccines containing B. burgdorferi s.l. outer surface protein A (OspA) can prevent human Lyme borreliosis (5,6). Indeed, a vaccine containing a single OspA antigen was marketed in the USA. Since OspA-mediated protection is largely type-specific, the heterogeneity in OspA sequences among European B. burgdorferi s.l. strains (7) precludes broad protection with a vaccine based on OspA from a single strain (8).

The elucidation of the structure of OspA (9) and identification of the major protective B-cell epitope (10) paved the way for the design of recombinant OspA molecules that contain the protective portions from two different OspA antigens. Baxter scientists have developed a candidate OspA chimaeric vaccine comprising three recombinant OspA antigens covering the 6 predominant OspA serotypes. These novel recombinant antigens are produced as lipoproteins in E.coli. Baxter’s chimaeric OspA vaccine will target all three B. burgdorferi s.l. genospecies (B. burgdorferi s.s., B. afzelii and B. garinii) and afford protection against all major clinical forms of Lyme disease, including invasive disease, found in the USA and Europe and perhaps worldwide.

Clinical trials to evaluate Baxter's OspA-based vaccine are planned to test whether the vaccine is well tolerated and immunogenic.

References:

  1. Report of WHO workshop on Lyme Borreliosis Diagnosis and Surveillance, Warsaw, Poland, 20-22 June, 1995, WHO/CDS/VPH/95. 141-1.
  2. Lyme disease - United States, 1999. MMWR Morb Mortal Wkly Rep, 2001. 50(10):181-185.
  3. Stanek, G., O?Connell, S., Cimmino, M., Aberer, E., Kristoferitsch, W:, Granström, M., Guy, E. and Gray, J. (1996) European Union Concerted Action on Risk Assessment in Lyme Borreliosis - Clinical Case Definitions for Lyme Borreliosis. Wien.Klin.Wochenschr. 108: 741-747.
  4. Weber, K. (1996). Treatment failure in Erythema migrans - A Review. Infection. 24:73-75.
  5. Steere AC, Sikand VK, Meurice F, Parenti DL, Fikrig E, Schoen RT, Nowakowski J, Schmid CH, Laukamp S, Buscarino C, Krause DS. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group. N Engl J Med. 1998 23;339(4):209-15.
  6. Sigal LH, Zahradnik JM, Lavin P, Patella SJ, Bryant G, Haselby R, Hilton E, Kunkel M, Adler-Klein D, Doherty T, Evans J, Molloy PJ, Seidner AL, Sabetta JR, Simon HJ, Klempner MS, Mays J, Marks D, Malawista SE. A vaccine consisting of recombinant Borrelia burgdorferi outer-surface protein A to prevent Lyme disease. Recombinant Outer-Surface Protein A Lyme Disease Vaccine Study Consortium. N Engl J Med. 1998 339(4):216-22. Erratum in: N Engl J Med 1998 20;339(8):571.
  7. Wilske B, Preac-Mursic V, Gobel UB, Graf B, Jauris S, Soutschek E, Schwab E, Zumstein G. An OspA serotyping system for Borrelia burgdorferi based on reactivity with monoclonal antibodies and OspA sequence analysis. J Clin Microbiol. 1993 31(2):340-50.
  8. Gern L, Hu CM, Voet P, Hauser P, Lobet Y. Immunization with a polyvalent OspA vaccine protects mice against Ixodes ricinus tick bites infected by Borrelia burgdorferi ss, Borrelia garinii and Borrelia afzelii. Vaccine. 1997 15(14):1551-7.
  9. Li H, Dunn JJ, Luft BJ, Lawson CL. Crystal structure of Lyme disease antigen outer surface protein A complexed with an Fab.
    Proc Natl Acad Sci U S A. 1997 94(8):3584-9.
  10. Ding W, Huang X, Yang X, Dunn JJ, Luft BJ, Koide S, Lawson CL. Structural identification of a key protective B-cell epitope in Lyme disease antigen OspA. J Mol Biol. 2000 302(5):1153-64.



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