To assess the reactogenicity and immunogenicity of the Biken acellular pert
ussis vaccine (Pa) following administration of a single vaccine dose to you
ng adults with or without a history of prior pertussis immunization, 104 he
althy, male and female adults without primary pertussis immunization were e
nrolled in Mainz (former West Germany; "not previously pertussis vaccinated
", N-PPV-group); in parallel, 103 adults with a history of having received
greater than or equal to four doses of a combined diphtheria-, tetanus-toro
id, whole-cell pertussis Vaccine (DTwP) were enrolled in Magdeburg (former
East Germany; "previously pertussis-vaccinated", PPV-group). Large areas of
redness (> 20 mm) were seen in 2.9%/1.0% of subjects in the N-PPV/PPV grou
p, and a large swelling was seen in 6.8%/1.0%, respectively. As compared to
baseline concentrations, antibody titers to PT and FHA were 77-(PT)/64-(FH
A) (N-PPV group) and 94-(PT)/126-(FHA) fold (PPV group) higher. The study v
accine was safe and induced infrequent and mostly mild, local and general s
ymptoms that all resolved spontaneously; it was highly immunogenic in adult
s, whether or not they had been previously vaccinated with DTwP. (C) 2000 E
lsevier Science Ltd. All rights reserved.