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NIAID ACELLULAR PERTUSSIS VACCINE STUDY OF 65,000 INFANTS IN SWEDEN

Executive Summary

NIAID ACELLULAR PERTUSSIS VACCINE STUDY OF 65,000 INFANTS IN SWEDEN will be conducted through Sweden's federal immunization system, NIAID Microbiolgy and Infectious Diseases Division Director John La Montagne, PhD, told the National Vaccine Advisory Committee March 19. Pertussis components under consideration for inclusion in the trial are SmithKline Beecham bivalent acellular and Connaught pentavalent acellular vaccine components, a Sclavo trivalent recombinant acellular vaccine component (Acelluvax), and a Medeva whole cell vaccine component currently being manufactured by Wellcome under an agreement with Medeva. The trial will be conducted at 2,000 sites throughout Sweden and include about half Sweden's annual birth total of 130,000 infants. It is expected to begin in September. A National Institute of Allergy and Infectious Diseases outline of the Swedish trial states that it "is designed to give a more definitive comparison between [acellular vaccine] and [whole cell vaccine]. It will also provide more data on the safety of both types of vaccine." Unlike a smaller, ongoing NIH four-arm trial in Sweden, this efficacy trial of the pertussis component of DTP (diphtheria-tetanus-pertussis) vaccines does not include blood collection. "Blinding is a major problem, no matter what you do, because of the anticipated high reactivity of the whole cell vaccine," La Montagne said. The Institute is considering the Wellcome/Medeva whole cell vaccine for the second trial because it is similar to U.S. whole cell vaccines, it is familiar to Swedish health care professionals, and it cannot be distinguished visually from the acellular products. La Montagne updated the committee on the progress of NIAID's first Swedish trial, which began in March 1992 ("The Pink Sheet" April 27, 1992, p. 8). He said that as of Jan. 15, approximately 8,390 infants had been enrolled, or about 35% of those eligible. There are four arms to the trial -- the SmithKline and Connaught acellular vaccines under consideration for inclusion in the second trial, a Connaught whole cell vaccine, and a DT vaccine without a pertussis component. NIAID is projecting total enrollment of about 9,800 in the first Swedish trial, a shortfall of 200 from the goal of 10,000. To compensate for this, the observation period has been extended from September 1995 to January 1996. La Montagne said about 310 pertussis cases are needed for the trial to be meaningful. La Montagne also reported on a third NIAID-sponsored acellular pertussis trial, which began in Italy in September 1992. The 61- center trial is designed like the ongoing Swedish trial, including active surveillance and blood sampling from 1,500 infants. Enrollment, originally estimated at 11,000, is "far exceeding [NIAID's] expectations" and is now projected to be 15,000. Vaccines being tested are SmithKline Beecham's bivalent acellular, Sclavo's trivalent recombinant acellular, and Connaught's whole cell, with a Sclavo diptheria-tetanus control. In addition to the two ongoing NIAID trials, there are four other efficacy trials of vaccines with acellular pertussis components in children currently underway. Both Lederle (Acel- Imune) and SmithKline Beecham are performing studies of their respective acellular vaccines in Germany. Institut Merieux, of which Connaught is an affiliate, has an ongoing trial in Senegal, and Amvax is testing its vaccine in Sweden ("The Pink Sheet" June 22, 1992, p. 9).
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