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Clinical Trial Demonstrates Lyme Disease Vaccine Reduces Overall Occurrence SAN FRANCISCO, CA. -- September 16, 1997 -- Preliminary results of a multicenter efficacy study of 10,306 adults has shown that recipients of Pasteur Merieux Connaught's candidate Lyme vaccine experienced a reduction in the overall occurrence of the disease when compared to the placebo group. The Phase III study results were presented yesterday by lead clinical trial investigator Leonard Sigal, M.D., of the Robert Wood Johnson Medical School, New Brunswick, N.J. at the 35th Annual Meeting of the Infectious Diseases Society of America. During the course of the randomized, double-blind, placebo-controlled study, volunteers received two doses of either the candidate Lyme vaccine or the placebo, one month apart, in the spring of 1994, and a third dose was administered one year later. "The results of this study show promise that a vaccine may be an important prevention option for those who wish to avoid Lyme disease in the future," Dr. Sigal said. Pasteur Merieux Connaught was the first company to initiate and complete clinical trials to determine whether a vaccine can protect humans against Lyme disease. The multicenter study was conducted at 14 locations in areas of the country where Lyme disease is endemic. Trial sites were situated in five states, including Connecticut, Massachusetts, New Jersey, New York, and Wisconsin. Study participants were scheduled to receive a total of three doses of vaccine or placebo over the course of two consecutive Lyme seasons. At the end of the second season, those who received three doses were observed for clinical and laboratory evidence of Lyme disease. Study data were collected and analyzed by two age groups, those under age 60 and those age 60 and over. Adverse reactions experienced by study participants who received the candidate vaccine included redness, swelling and soreness at the site of the injection, as may be expected from the administration of an intramuscular vaccine. These adverse reactions resolved themselves within 24 to 48 hours. An independent Data and Safety Monitoring Board reported generally no differences in adverse reactions between the vaccine recipients and the placebo recipients. Subsequent analysis by Pasteur Merieux Connaught showed the only differences observed between the two groups were in the immediate post-immunization period. For the two week post-immunization period, symptoms such as headache, myalgia and chills were seen more frequently in the vaccine group than in the placebo group. "The promising results of this large-scale trial have led Pasteur Merieux Connaught to prepare to submit a Product License Application (PLA) to the U.S. Food and Drug Administration," said John Zahradnik, M.D., director of Clinical Affairs, Pasteur Merieux Connaught. Lyme disease is the most common tick-borne disease in the United States. It is caused by a spirochete, or spiral-shaped bacterium, called Borrelia burgdorferi, and is transmitted by the bite of certain ticks. In 1996, over 16,000 cases of Lyme disease were reported to the U.S. Center for Disease Control and Prevention. Pasteur Merieux Connaught's developed its candidate Lyme disease vaccine, Borrelia burgdorferi Outer Surface Protein A, using recombinant technology. In this process, a protein from the Lyme-disease causing spirochete is produced using genetic engineering techniques. The recombinant protein -- called outer surface protein A, or OspA -- was chosen for use in the vaccine group because it stimulates a protective immune response. The vaccine will be marketed under the trade name ImuLyme(TM). E-mail this page to a friend or colleague! To print, use this version