Immunogenicity and reactogenicity of the Biken acellular pertussis vaccine in young adults.

ABSTRACT

To assess the reactogenicity and immunogenicity of the Biken acellular pertussis vaccine (Pa) following administration of a single vaccine dose to young adults with or without a history of prior pertussis immunization, 104 healthy, male and female adults without primary pertussis immunization were enrolled in Mainz (former West Germany; "not previously pertussis vaccinated", N-PPV-group); in parallel, 103 adults with a history of having received >/=four doses of a combined diphtheria-, tetanus-toxoid, 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 group, 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-(FHA) (N-PPV group) and 94-(PT)/126-(FHA) fold (PPV group) higher. The study vaccine was safe and induced infrequent and mostly mild, local and general symptoms that all resolved spontaneously; it was highly immunogenic in adults, whether or not they had been previously vaccinated with DTwP.