A Vaccine Consisting of RecombinantBorrelia burgdorferiOuter-Surface Protein A to Prevent Lyme Disease
| Autor: | D. Marks, M. Kunkel, J R Sabetta, Mark S. Klempner, Leonard H. Sigal, T. Doherty, Philip J. Molloy, R. Haselby, D. Adler-Klein, H J Simon, A L Seidner, Gary L. Bryant, J. Evans, P Lavin, E Hilton, J Mays, Stephen E. Malawista, J M Zahradnik, S J Patella |
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| Rok vydání: | 1998 |
| Předmět: | |
| Zdroj: | New England Journal of Medicine. 339:216-222 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejm199807233390402 |
| Popis: | Background Lyme disease is a multisystem inflammatory disease caused by infection with the tick-borne spirochete Borrelia burgdorferi and is the most common vector-borne infection in the United States. We assessed the efficacy of a recombinant vaccine consisting of outer-surface protein A (OspA) without adjuvant in subjects at risk for Lyme disease. Methods For this double-blind trial, 10,305 subjects 18 years of age or older were recruited at 14 sites in areas of the United States where Lyme disease was endemic; the subjects were randomly assigned to receive either placebo (5149 subjects) or 30 μg of OspA vaccine (5156 subjects). The first two injections were administered 1 month apart, and 7515 subjects also received a booster dose at 12 months. The subjects were observed for two seasons during which the risk of transmission of Lyme disease was high. The primary end point was the number of new clinically and serologically confirmed cases of Lyme disease. Results The efficacy of the vaccine was 68 percen... |
| Databáze: | OpenAIRE |
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