Vaccination against lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant

New England Journal of Medicine

Volumn 339, Issue 4, 1998, Pages 209-215

  Steere, Allen C ^a,f   Sikand, Vijay K ^a   Meurice, François ^b   Parenti, Dennis L ^b   Fikrig, Erol ^c   Schoen, Robert T ^c   Nowakowski, John ^d   Schmid, Christopher H ^a   Laukamp, Sabine ^e   Buscarino, Charles ^b   Krause, David S ^b  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b GLAXOSMITHKLINE   (United Kingdom)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d NEW YORK MEDICAL COLLEGE   (United States)

^e Kendle   (Germany)

^f TUFTS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL VACCINE; FREUND ADJUVANT; RECOMBINANT VACCINE;

ACTIVE IMMUNIZATION; ADOLESCENT; ADULT; AGED; ARTICLE; BORRELIA BURGDORFERI; CHILL; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; ENDEMIC DISEASE; FEVER; FOLLOW UP; HUMAN; IMMUNOGENICITY; INFECTION PREVENTION; LYME DISEASE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MYALGIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SERODIAGNOSIS; TREATMENT OUTCOME;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; ANTIBODIES, BACTERIAL; ANTIGENS, SURFACE; BACTERIAL OUTER MEMBRANE PROTEINS; BACTERIAL VACCINES; BORRELIA BURGDORFERI GROUP; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNIZATION SCHEDULE; LIPOPROTEINS; LYME DISEASE; MALE; MIDDLE AGED; TREATMENT OUTCOME; VACCINES, SYNTHETIC;

EID: 0032560841     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199807233390401     Document Type: Article

References (31)

1. Lyme disease - United States, 1995. MMWR Morb Mortal Wkly Rep 1996;45:481-4.
2. Stecre AC, Malawista SE, Snydman DR, et al. Lyme arthritis: an epidemic of oligoarticular arthritis in children and adults in three Connecticut communities. Arthritis Rheum 1977;20:7-17.
3. Steere AC, Malawista SE, Hardin JA, Ruddy S, Askenase W, Andiman WA. Erythema chronicum migrans and Lyme arthritis: the enlarging clinical spectrum. Ann Intern Med 1977;86:685-98.
4. Edelman R. Perspective on the development of vaccines against Lyme disease. Vaccine 1991;9:531-2.
5. Fikrig E, Barthold SW, Kantor FS, Flavell RA. Protection of mice against the Lyme disease agent by immunizing with recombinant OspA. Science 1990;250:553-6.
6. Schaible UE, Kramer MD, Eichmann K, Modolell M, Muscteanu C, Simon MM. Monoclonal antibodies specific for the outer surface protein A (OspA) of Borrelia burgdorferi prevent Lyme borreliosis in severe combined immunodeficiency (scid) mice. Proc Natl Acad Sci U S A 1990;87: 3768-72.
7. Lovrich SD, Callister SM, DuChateau BK, et al. Abilities of OspA proteins from different seroprotective groups of Borrelia burgdorferi to protect hamsters from infection. Infect Immun 1995;63:2113-9.
8. Chang YF, Appel MJ, Jacobson RH, et al. Recombinant OspA protects dogs against infection and disease caused by Borrelia burgdorferi. Infect Immun 1995;63:3543-9.
9. Philipp MT, Lobet Y, Bohm RP Jr, et al. Safety and immunogenicity of recombinant outer surface protein A (OspA) vaccine formulations in the rhesus monkey. J Spirochetal Tickborne Dis 1996;3:1-13.
10. Schoen RT, Meurice F, Brunet CM, et al. Safety and immunogenicity of an outer surface protein A vaccine in subjects with previous Lyme disease. J Infect Dis 1995;172:1324-9.
11. Goldstein MD, Schwartz BS, Friedmann C, Maccarillo B, Borbi M, Tuccillo R. Lyme disease in New Jersey outdoor workers: a statewide survey of seroprevalence and tick exposure. Am J Public Health 1990;80:1225-9.
12. Hanrahan JP, Benach J, Coleman JL, et al. Incidence and cumulative frequency of endemic Lyme disease in a community. J Infect Dis 1984;150: 489-96.
13. Lastavica CC, Wilson ML, Berardi VP, Spielman A, Deblinger RD. Rapid emergence of a focal epidemic of Lyme disease in coastal Massachusetts. N Engl J Med 1989;320:133-7.
14. Steere AC, Taylor E, Wilson ML, Levine JF, Spielman A. A longitudinal assessment of the clinical and epidemiologic features of Lyme disease in a defined population. J Infect Dis 1986;154:295-300.
15. O'Neill RT. On sample sizes to estimate the protective efficacy of a vaccine. Stat Med 1988;7:1279-88.
16. Rahn DW, Malawista SE. Lyme disease: recommendations for diagnosis and treatment. Ann Intern Med 1991;114:472-81.
17. Recommendations for test performance and interpretation from the Second International Conference on Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep 1995;44:590-1.
18. Berger BW, Johnson RC, Kodner C, Coleman L. Cultivation of Borrelia burgdorferi from erythema migrans lesions and perilesional skin. J Clin Microbiol 1992;30:359-61.
19. Nocton JJ, Dressler F, Rutledge BJ, Rys PN, Persing DH, Steere AC. Detection of Borrelia burgdorferi DNA by polymerase chain reaction in synovial fluid from patients with Lyme arthritis. N Engl J Med 1994;330:229-34.
20. Nocton JJ, Bloom BJ, Rutledge BJ, et al. Detection of Borrelia burgdorferi DNA by polymerase chain reaction in cerebrospinal fluid in Lyme neuroborreliosis. J Infect Dis 1996;174:623-7.
21. Sears JE, Fikrig E, Nakagawa TY, et al. Molecular mapping of Osp-A mediated immunity against Borrelia burgdorferi, the agent of Lyme disease. J Immunol 1991;147:1995-2000.
22. Van Hoecke C, Comberbach M, De Grave D, et al. Evaluation of the safety, reactogenicity, and immunogenicity of three recombinant outer surface protein (OspA) Lyme vaccines in healthy adults. Vaccine 1996;14:1620-6.
23. Micttinen O, Nurminen M. Comparative analysis of two rates. Stat Med 1985;4:213-26.
24. Klein JP, Moeschberger ML. Survival analysis: techniques for censored and truncated data. New York: Springer-Verlag, 1997.
25. Fikrig E, Telford SR III, Barthold SW, Kantor FS, Spielman A, Flavell RA Elimination of Borrelia burgdorferi from vector ticks feeding on OspA-immunized mice. Proc Natl Acad Sci U S A 1992;89:5418-21.
26. Feder HM Jr, Whitaker DL. Misdiagnosis of erythema migrans. Am J Med 1995;99:412-9.
27. Krause PJ, Telford SR III, Spielman A, et al. Concurrent Lyme disease and babesiosis: evidence for increased severity and duration of illness. JAMA 1996;275:1657-60.
28. Wormser GP, Horowitz HW, Nowakowski J, et al. Positive Lyme disease serology in patients with clinical and laboratory evidence of human granulocytic ehrlichiosis. Am J Clin Pathol 1997;107:142-7.
29. Kalish RA, Leong JM, Steere AC. Association of treatment-resistant chronic Lyme arthritis with HLA-DR4 and antibody reactivity to OspA and OspB of Borrelia burgdorferi. Infect Immun 1993;61:2774-9.
30. Lengl-Janssen B, Strauss AF, Steere AC, Kamradt T. The T helper cell response in Lyme arthritis: differential recognition of Borrelia burgdorferi outer surface protein A in patients with treatment-resistant or treatment-responsive Lyme arthritis. J Exp Med 1994;180:2069-78.
31. Gross DM, Forsthuber T, Tary-Lehmann M, et al. Identification of LFA-1 as a candidate autoantigen in treatment-resistant Lyme arthritis. Science (in press).