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Tolerability and antibody response in adolescents and adults revaccinated with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) 4-5 years after a previous dose
Authors:Halperin Scott A  McNeil Shelly  Langley Joanne  Blatter Mark  Dionne Marc  Embree Joanne  Johnson Roehl  Latiolais Thomas  Meekison William  Noya Francisco  Senders Shelly  Zickler Paul  Johnson David R
Institution:a Canadian Center for Vaccinology, Dalhousie University, Capital Health, and the IWK Health Centre, Halifax, NS, Canada
b Primary Physicians Research, Inc., Pittsburgh, PA, USA
c Institut national de santé publique du Québec, Beauport, QC, Canada
d Manitoba Institute of Child Health, John Buhler Research Centre, and the Children's Hospital Foundation of Manitoba, Winnipeg, MB, Canada
e The Jonesboro Children's Clinic, Jonesboro, AR, USA
f Ark-La-Tex Children's Clinic, Bossier City, LA, USA
g Westcoast Clinical Research, North Vancouver, BC, Canada
h Department of Infectious Diseases, McGill University Health Centre and Montreal Children's Hospital, Montreal, QC, Canada
i Senders Pediatrics, University Heights, OH, USA
j TASC-CMX Research Services Inc., Surrey, BC, Canada
k Scientific and Medical Affairs Department, Sanofi Pasteur, Swiftwater, PA, USA
Abstract:

Background

Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine is not currently recommended for adults.

Methods

This open-label, postmarketing, multicenter study evaluated the tolerability and immunogenicity of a second dose of an adult formulation of tetanus, diphtheria, and pertussis vaccine (Tdap) in adolescents and adults 5 years after a first dose.

Results

A total of 545 participants from previous Tdap vaccine studies, ranging in age from 15 to 69 years, participated in this study. Of these participants, 94.2% had at least one solicited adverse event after the booster dose such as injection-site erythema (28.6%), swelling (25.6%), or pain (87.6%) or a systemic adverse event such as myalgia (61.0%), headache (53.2%), malaise (38.2%), or fever (6.5%). These adverse events were slightly more frequent than after the initial dose. Postvaccination, 100% of participants had a tetanus antibody level ≥0.10 IU/mL and 95% had a diphtheria antibody level ≥0.10 IU/mL. For pertussis, 82.1% (pertussis toxoid), 96.7% (filamentous hemagglutinin), 95.6% (pertactin), and 99.8% (fimbriae) had a postvaccination antibody threshold of ≥50 EU/mL.

Conclusion

A second dose of Tdap vaccine 5 years after the initial dose was well tolerated and immunogenic in adolescents and adults.
Keywords:Adult immunization  Adolescent immunization  Tetanus vaccine  Diphtheria vaccine  Acellular pertussis vaccine
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