North American Vaccine Inc.'s Phase III trial of itsDiphtheria/Tetanus/Acellular Pertussis (DTaP) vaccine iscomplete, and results are expected to be released inSeptember.The randomized, double-blind, placebo-controlled trialinvolved 3,450 infants in Sweden. About half received theDTaP vaccine and half were given a diphtheria/tetanusvaccine as placebo. Sharon Mates, president of theBeltsville, Md., company, told BioWorld the trial's codehas not been broken. The date for disclosure of results hasnot been determined, she said.The trial was sponsored by the National Institute of ChildHealth and Human Development (NICHD) of the NationalInstitutes of Health and was conducted under a U.S.investigational new drug application. Sweden was selectedas the site because that country stopped vaccinatingchildren against pertussis, or whooping cough, in 1979 dueto adverse reactions.North American Vaccine's acellular vaccine consists ofpertussis toxin that has been purified and chemicallyinactivated, rather than the whole Bordetella pertussisbacteria. It excludes components used in current "wholecell" pertussis vaccines that are believed to be associatedwith adverse reactions, such as rashes and fevers, Matessaid.A European study combining the DTaP vaccine with aninjectible polio vaccine is nearing completion, and a U.S.safety and immunogenicity study is expected to becompleted in September, Mates said. DTaP is the leadproduct for the company, which has 16 vaccines in clinicaltrials or in development, she said."We are presently preparing our product license applicationand establishment license application for submission to theFDA," Mates said. "We hope to submit those by the end ofthe year or early next year," assuming the DTaP vaccine isapproved. "Our hope is to be a major player in the marketplace."News of the three-year-old trial's completion, releasedWednesday, sent North American Vaccine's(AMEX:NVX) stock up $1.25 per share, to $9.88. Thestock lost 13 cents Thursday to close at $9.75. n
-- Jim Shrine
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