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


OBJECTIVE
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.


METHODS
The study addressed 1207 healthy participants (736 adults and 466 adolescents) recruited in five Canadian communities.


METHODS
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.


METHODS
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.
Halperin
S A
SA
Department of Pediatrics, Dalhousie University and the IWK Grace Health Centre, Halifax, Nova Scotia, Canada. shalperin@iwkgrace.ns.ca
Smith
B
B
Russell
M
M
Scheifele
D
D
Mills
E
E
Hasselback
P
P
Pim
C
C
Meekison
W
W
Parker
R
R
Lavigne
P
P
Barreto
L
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000917:Antibody Formation / Q000276:immunology; D002626:Chemistry, Pharmaceutical; D002648:Child; D016001:Confidence Intervals; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D012680:Sensitivity and Specificity; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014121:Toxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination / Q000379:methods; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D004168:Diphtheria Toxoid; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D014121:Toxoids; D017778:Vaccines, Combined; D015164:Vaccines, Inactivated; C051093:pertussis toxoid