Vaccination against Lyme Disease with Recombinant Borrelia burgdorferi Outer-Surface Lipoprotein A with Adjuvant
Allen C. Steere, M.D., Vijay K. Sikand, M.D., François Meurice, M.D., Dennis L. Parenti, M.D., Erol Fikrig, M.D., Robert T. Schoen, M.D., John Nowakowski, M.D., Christopher H. Schmid, Ph.D., Sabine Laukamp, Charles Buscarino, B.Sc., David S. Krause, M.D., for The Lyme Disease Vaccine Study Group
Background The risk of acquiring Lyme disease is high in areasin which the disease is endemic, and the development of a safeand effective vaccine is therefore important.
Methods We conducted a multicenter, double-blind, randomizedtrial involving 10,936 subjects who lived in areas of the UnitedStates in which Lyme disease is endemic. Participants receivedan injection of either recombinant Borrelia burgdorferi outer-surfacelipoprotein A (OspA) with adjuvant or placebo at enrollmentand 1 and 12 months later. In cases of suspected Lyme disease,culture of skin lesions, polymerase-chain-reaction testing,or serologic testing was done. Serologic testing was performed12 and 20 months after study entry to detect asymptomatic infections.
Results In the first year, after two injections, 22 subjectsin the vaccine group and 43 in the placebo group contracteddefinite Lyme disease (P=0.009); vaccine efficacy was 49 percent(95 percent confidence interval, 15 to 69 percent). In the secondyear, after the third injection, 16 vaccine recipients and 66placebo recipients contracted definite Lyme disease (P<0.001);vaccine efficacy was 76 percent (95 percent confidence interval,58 to 86 percent). The efficacy of the vaccine in preventingasymptomatic infection was 83 percent in the first year and100 percent in the second year. Injection of the vaccine wasassociated with mild-to-moderate local or systemic reactionslasting a median of three days.
Conclusions Three injections of vaccine prevented most definitecases of Lyme disease or asymptomatic B. burgdorferi infection.
Source Information
From the Division of Rheumatology and Immunology (A.C.S., V.K.S.) and Clinical Care Research (C.H.S.), Tufts University School of Medicine, New England Medical Center, Tupper Research Institute, Boston; Research and Development, SmithKline Beecham Pharmaceuticals, Collegeville, Pa. (F.M., D.L.P., C.B., D.S.K.); the Department of Medicine, Yale University School of Medicine, New Haven, Conn. (E.F., R.T.S.); the Division of Infectious Diseases, New York Medical College, Valhalla (J.N.); and Kendle/gmi, Munich, Germany (S.L.).
Address reprint requests to Dr. Steere at New England Medical Center, Box 406, 750 Washington St., Boston, MA 02111.
Immunization against Lyme Disease
Hayes E. B., Dennis D. T., Luger S., Anderson J. R., Steere A. C., Parenti D. L., Krause D. S., Sigal L. H., Zahradnik J., Weinstein A.
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N Engl J Med 1998;
339:1637-1639, Nov 26, 1998.
Correspondence
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