Adverse reactions and antibody response to an acellular pertussis toxoid vaccine in adult volunteers.

A monovalent pertussis toxoid vaccine (JNIH-7, Biken, Japan) was evaluated for reactogenicity and immunogenicity in 20 healthy adults (phase 1 study). Fever of greater than or equal to 38 degrees C was recorded in 2/20; local reactions started in 2/20 on day 1 (early onset) and in 3/20 on day 7 (late onset). All 15/15 subjects tested showed a significant antibody response to pertussis toxin by neutralization or enzyme-linked immunosorbent assay. Significantly elevated antibodies were still detected in 12/13 subjects 32 months after the single subcutaneous dose of vaccine.