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

Abstract

BACKGROUND:

Pertussis is increasingly recognized as an important cause of cough illness in adolescents and adults.

PURPOSE:

To evaluate the safety and antibody response to a single dose of an adult formulation of a five component (pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae 2 and 3) acellular pertussis vaccine (aP) combined with diphtheria and tetanus toxoids (TdaP) and inactivated poliovirus vaccine (TdaP-IPV) in adolescents and adults and to assess the response to a second dose of the acellular pertussis vaccine in a subset of the adults.

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, adult participants received Td followed at a separate visit by aP, TdaP followed 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 immunization; 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, but reaction rates did not differ significantly among the latter products. The antibody response against Bordetella pertussis antigens was vigorous in all groups, although adults given the TdaP-IPV vaccine had lower antibody titers against filamentous hemagglutinin, pertactin, diphtheria and tetanus antibodies than those given TdaP vaccine. Similarly adolescents given TdaP-IPV had lower antibody titers against pertussis toxin, filamentous hemagglutinin, fimbriae and agglutinins than those given Td-IPV and aP alone. A second dose of acellular pertussis vaccine was not associated with increased adverse events in adults but elicited increased antibody titers over that achieved by 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 vaccine for adolescent and adult immunization programs.

• Authors: S A Halperin, B Smith, M Russell, D Scheifele, E Mills, P Hasselback, C Pim, W Meekison, R Parker, P Lavigne, L Barreto
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 19 Issue 4 Pg. 276-83 (Apr 2000) ISSN: 0891-3668 [Print] United States
• PMID: 10783014 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Diphtheria Toxoid
• Poliovirus Vaccine, Inactivated
• Tetanus Toxoid
• Toxoids
• Vaccines, Combined
• Vaccines, Inactivated
• pertussis toxoid

Topics

• Adolescent
• Adult
• Aged
• Antibody Formation (immunology)
• Chemistry, Pharmaceutical
• Child
• Confidence Intervals
• Diphtheria Toxoid (administration & dosage, adverse effects, immunology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects, immunology)
• Sensitivity and Specificity
• Tetanus Toxoid (administration & dosage, adverse effects, immunology)
• Toxoids (administration & dosage, adverse effects, immunology)
• Vaccination (methods)
• Vaccines, Combined (adverse effects, immunology)
• Vaccines, Inactivated (administration & dosage, adverse effects, immunology)