Adult formulation of a five component acellular pertussis vaccine combinedwith diphtheria and tetanus toxoids and inactivated poliovirus vaccine is safe and immunogenic in adolescents and adults

Background. Pertussis is increasingly recognized as an important cause of c ough illness inn adolescents and adults, Purpose. To evaluate the safety and antibody response to a single dose of a n adult formulation of a five component (pertussis toxoid, filamentous hema gglutinin, pertactin, fimbriae 2 and 3) acellular pertussis vaccine (aP) co mbined with diphtheria and tetanus toxoids (TdaP) and inactivated polioviru s vaccine (TdaP-IPV) in adolescents and adults and to assess the response t o a second dose of the acellular pertussis vaccine in a subset of the adult s, Population and setting. The study addressed 1207 healthy participants (736 adults and 466 adolescents) recruited in five Canadian communities, Study design, in a randomized, observer-blind, controlled clinical trial, a dult participants received Td followed at a separate visit by aP, TdaP foll owed by IPV or TdaP-IPV; adolescents received Td-IPV followed at a separate visit by aP or TdaP-IPV. A subgroup of adults was given a booster of aP 1 month after TdaP. Outcome measures. Antibody titers measured before and 1 month after each im munization; adverse events enumerated at 24 h, 72 h and 8 to 10 days. Results. The aP vaccine given by itself was associated with adverse events less frequently than were Td, Td-IPV, TdaP or TdaP-IPV vaccines, hut reacti on rates did not differ significantly among the latter products, The antibo dy response against Bordetella pertussis antigens was vigorous in all group s, although adults given the TdaP-IPV vaccine had newer antibody titers aga inst filamentous hemagglutinin, pertactin, diphtheria and tetanus antibodie s than those given TdaP vaccine, Similarly adolescents given TdaP-IPV had l ower antibody titers against pertussis toxin, filamentous hemaagglutinin, f imbriae and agglutinins than those given Td-IPV and aP alone. A second dose of acellular pertussis vaccine was not associated with increased adverse e vents in adults but elicited increased antibody titers over that achieved b y a single dose only against pertussis toxin, Conclusions, This adult formulation five component aP vaccine given as TdaP -IPV is safe and immunogenic in adolescents and adults and is a candidate v accine for adolescent and adult immunization programs.