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CONNAUGHT LABORATORIES' LYME DISEASE VACCINE IS FIRST IN WORLD TO BE TESTED IN HUMAN VOLUNTEERS

 CONNAUGHT LABORATORIES' LYME DISEASE VACCINE IS FIRST
 IN WORLD TO BE TESTED IN HUMAN VOLUNTEERS
 /ADVANCE/ SWIFTWATER, Pa., Oct. 14 /PRNewswire/ -- Connaught Laboratories, Inc. today announced the launch of a clinical trial of a candidate vaccine for Lyme disease -- the first Lyme vaccine in the world to be tested in humans.
 The clinical trial, which will test the safety of the vaccine in humans, is being conducted at the University of New Mexico Medical School in Albuquerque. Antibody response to the vaccine will also be evaluated. The Food and Drug Administration recently granted Connaught Laboratories, Inc. what is known as an IND (Investigational New Drug) for the vaccine, which is required before any drug or biologic may be tested in humans, and is based upon evaluation of pre-clinical data from laboratory and animal testing.
 Earlier studies showed that the vaccine provided complete protection against Lyme disease in mice. Results from the current trial in humans are expected early next year.
 "As Lyme disease is a major health threat, it is critical to explore how it might be prevented," said David J. Williams, president and chief operating officer of Connaught Laboratories, Inc. "As a company devoted solely to the development and manufacture of vaccines, Connaught is hopeful that this candidate vaccine will further scientific progress in the fight against this disease."
 The Connaught Lyme vaccine was developed using recombinant technology. In this process, a protein from the Lyme-causing organism that is thought to stimulate the immune system is identified and replicated using modern genetic engineering techniques. Work on the cloning of the protein was done by Alan G. Barbour, M.D., of the University of Texas and Dr. Sven Bergstrom of the University of Umea, Sweden. Dr. Barbour continues to work with Connaught on Lyme vaccine development.
 "The high level of immune response to this vaccine in laboratory mice makes it a good candidate for humans," noted Frederick T. Koster, M.D., of the University of New Mexico School of Medicine, who is the principal trial investigator. "The first step in the process, and the goal of this study, is to make sure the vaccine is safe for humans."
 Nearly 10,000 cases of Lyme disease were reported last year to the U.S. Centers for Disease Control, but some experts believe the actual number may be up to ten times higher. The disease is transmitted by infected ticks and is considered by many experts to be difficult to diagnose and treat.
 "Lyme disease infection costs society $1 billion a year, and is a serious and debilitating illness that can cause a host of problems, such as chronic brain, joint and heart infection," said Karen Vanderhoof- Forschner, B.S., M.B.A., chair of the Lyme Disease Foundation, which provided funds in support of one of the scientists working on the vaccine at the University of Texas. "Reaching the point where we can test a candidate vaccine for Lyme is a milestone in the effort to protect people against the ravages of this disease. Until a vaccine is available, however, people need to protect and check themselves against ticks."
 Study Will Focus on Safety
 The double-blind trial, to be conducted by researchers at the University of New Mexico School of Medicine, will evaluate the safety of the vaccine in healthy volunteers.
 One-third of the subjects will be randomly assigned to a form of the vaccine containing an adjuvant, a substance added to increase antibody response; one-third will receive vaccine without the adjuvant. The remaining one-third will receive a placebo (saline solution). A second identical dose (booster) of each preparation will be administered 30 days after the initial immunization.
 At intervals of one, three, seven and 30 days following each vaccination, participants will be evaluated for reactions at the site of the injection, as well as reactions involving the entire body. In addition, blood samples will be drawn at regular intervals to evaluate antibody levels -- a measure of immune response.
 Connaught Laboratories, Inc., headquartered in Swiftwater, Pa., is a wholly owned subsidiary of Connaught Laboratories Limited, of Toronto, Canada, part of the Pasteur Merieux group of companies, the world's largest developer and manufacturer of vaccines for human use. Connaught Laboratories, Inc. provides the broadest range of vaccines and biologicals commercially available in the United States from a single company.
 Connaught Laboratories, Inc. is actively involved in immunological research, as well as the manufacture, marketing and distribution of vaccines against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, influenza, yellow fever, rabies, Japanese encephalitis and other diseases.
 -0- 10/14/92/1900
 /CONTACT: Lenore Cooney or Sherri Michelstein of Cooney/Waters Group, 212-557-7111, for Connaught Laboratories, Inc./ CO: Connaught Laboratories, Inc. ST: Pennsylvania IN: MTC SU:


PS-OS -- NY033 -- 9858 10/14/92 12:25 EDT
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