Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose.
Adhesins, Bacterial
/ immunology
Adolescent
Adult
Antibodies, Bacterial
/ blood
Antibody Formation
Antigens, Bacterial
Bacterial Outer Membrane Proteins
/ immunology
Canada
Diphtheria
/ prevention & control
Diphtheria-Tetanus-acellular Pertussis Vaccines
/ administration & dosage
Female
Fimbriae, Bacterial
/ immunology
Humans
Immunization, Secondary
/ methods
Immunogenicity, Vaccine
Injection Site Reaction
/ immunology
Male
Middle Aged
Tetanus
/ prevention & control
Time Factors
Toxoids
/ immunology
United States
Vaccination
Virulence Factors, Bordetella
/ immunology
Young Adult
Tdap
and acellular pertussis vaccine
booster
diphtheria
pertussis
tetanus
Journal
Journal of the Pediatric Infectious Diseases Society
ISSN: 2048-7207
Titre abrégé: J Pediatric Infect Dis Soc
Pays: England
ID NLM: 101586049
Informations de publication
Date de publication:
11 May 2019
11 May 2019
Historique:
received:
05
10
2017
accepted:
17
01
2018
pubmed:
14
2
2018
medline:
30
10
2019
entrez:
14
2
2018
Statut:
ppublish
Résumé
Reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries for boosting immunity in adolescents and adults. Although immunity to these antigens wanes with time, currently available Tdap products are not labeled for repeat administration in the United States. We performed an observer-blinded, randomized controlled trial in 1330 adults aged 18 to <65 years who received either the Tdap (n = 1002) or tetanus-diphtheria (Td) (n = 328) vaccine 8 to 12 years after a dose of Tdap vaccine administered previously. Solicited adverse events following immunization were documented for 7 days after vaccination, and serious adverse events and adverse events of medical significance were documented for 6 months after vaccination. Levels of antibodies against component vaccine antigens were measured before and 1 month after vaccination. A solicited adverse event was reported by 87.7% of Tdap and 88.0% of Td vaccine recipients. We found no significant differences in the rates of injection-site reactions, systemic reactions, or serious adverse events between the vaccine groups. A robust antibody response to each pertussis antigen in the Tdap-vaccinated group was found; postvaccination-to-prevaccination geometric mean antibody concentration ratios were 8:1 (pertussis toxoid), 5.9 (filamentous hemagglutinin), 6.4 (pertactin), and 5.2 (fimbriae 2 and 3). Postvaccination geometric mean concentrations of tetanus antibody (4.20 and 4.74 IU/mL, respectively) and diphtheria antibody (10.1 and 12.6 IU/mL, respectively) were similar in the Tdap and Td groups, and the rates of seroprotection against tetanus and diphtheria were >99% in both groups. A second dose of Tdap vaccine in adults approximately 10 years after a previous dose was well tolerated and immunogenic. These data might facilitate consideration of providing Tdap booster doses to adults.
Sections du résumé
BACKGROUND
BACKGROUND
Reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries for boosting immunity in adolescents and adults. Although immunity to these antigens wanes with time, currently available Tdap products are not labeled for repeat administration in the United States.
METHODS
METHODS
We performed an observer-blinded, randomized controlled trial in 1330 adults aged 18 to <65 years who received either the Tdap (n = 1002) or tetanus-diphtheria (Td) (n = 328) vaccine 8 to 12 years after a dose of Tdap vaccine administered previously. Solicited adverse events following immunization were documented for 7 days after vaccination, and serious adverse events and adverse events of medical significance were documented for 6 months after vaccination. Levels of antibodies against component vaccine antigens were measured before and 1 month after vaccination.
RESULTS
RESULTS
A solicited adverse event was reported by 87.7% of Tdap and 88.0% of Td vaccine recipients. We found no significant differences in the rates of injection-site reactions, systemic reactions, or serious adverse events between the vaccine groups. A robust antibody response to each pertussis antigen in the Tdap-vaccinated group was found; postvaccination-to-prevaccination geometric mean antibody concentration ratios were 8:1 (pertussis toxoid), 5.9 (filamentous hemagglutinin), 6.4 (pertactin), and 5.2 (fimbriae 2 and 3). Postvaccination geometric mean concentrations of tetanus antibody (4.20 and 4.74 IU/mL, respectively) and diphtheria antibody (10.1 and 12.6 IU/mL, respectively) were similar in the Tdap and Td groups, and the rates of seroprotection against tetanus and diphtheria were >99% in both groups.
CONCLUSIONS
CONCLUSIONS
A second dose of Tdap vaccine in adults approximately 10 years after a previous dose was well tolerated and immunogenic. These data might facilitate consideration of providing Tdap booster doses to adults.
Identifiants
pubmed: 29438562
pii: 4845935
doi: 10.1093/jpids/pix113
pmc: PMC6510947
doi:
Substances chimiques
Adhesins, Bacterial
0
Antibodies, Bacterial
0
Antigens, Bacterial
0
Bacterial Outer Membrane Proteins
0
Diphtheria-Tetanus-acellular Pertussis Vaccines
0
Toxoids
0
Virulence Factors, Bordetella
0
filamentous hemagglutinin adhesin, Bordetella pertussis
0
pertussis toxoid
0
pertactin
63GD90PP8X
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
105-114Informations de copyright
© The Author(s) 2018. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society.
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