Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP

Michael D Decker; David P Greenberg; David R Johnson; Vitali Pool

doi:10.1016/j.vaccine.2019.07.015

Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP

Vaccine. 2019 Aug 14;37(35):5003-5008. doi: 10.1016/j.vaccine.2019.07.015. Epub 2019 Jul 10.

Authors

Michael D Decker¹, David P Greenberg², David R Johnson³, Vitali Pool⁴

Affiliations

¹ US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN, USA. Electronic address: td551@mdd1.org.
² US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
³ Global Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA.
⁴ US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA.

PMID: 31301919
DOI: 10.1016/j.vaccine.2019.07.015

Abstract

Background: It has been reported that persons primed with acellular (DTaP) pertussis vaccines have reduced duration of pertussis protection compared with those primed with whole-cell (DTwP) vaccines. However, due to the rapid transition to acellular vaccines, studies attempting directly to compare protection among DTaP-primed vs DTwP-primed individuals are subject to confounding by age and other limitations of ecological studies. Using validated assay results and stored sera from multiple Tdap studies, we evaluated two licensed Tdap vaccines among DTaP-primed adolescents to allow comparison with results obtained in the same laboratory from earlier studies involving DTwP-primed adolescents.

Methods: Participants 11-12 years of age who had received exactly 5 doses of DTaP vaccine prior to 7 years of age were randomly assigned in 2012 to receive one of two licensed Tdap vaccines. Serum specimens obtained pre- and post-vaccination were assayed for responses to the vaccines. Current results were then compared to results obtained in the same laboratory from prior randomized Tdap studies conducted among adolescents primed with DTwP or DTaP.

Results: Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine. However, postvaccination pertussis antibody responses were as much as 71% lower in these DTaP-primed adolescents compared with responses among DTwP-primed adolescents in a prior study of the same two Tdap vaccines. In contrast, results from the present study were similar to those seen in another study of Tdap among DTaP-primed adolescents.

Discussion: Taken together, these results from randomized clinical trials provide direct evidence of reduced antibody responses to both licensed Tdap vaccines among adolescents primed with DTaP vaccine, compared with adolescents primed with DTwP vaccine. Clinical trial registry number: ClinicalTrials.gov, NCT01629589.

Keywords: Immunogenicity; Pertussis vaccine; Tdap vaccine; Vaccines, acellular.

Publication types

Clinical Trial, Phase IV
Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Age Factors
Antibodies, Bacterial / blood*
Child
Diphtheria / prevention & control
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine / immunology*
Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage
Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology*
Humans
Immunization, Secondary*
Immunogenicity, Vaccine*
Tetanus / prevention & control
Whooping Cough / prevention & control

Substances

Antibodies, Bacterial
Diphtheria-Tetanus-Pertussis Vaccine
Diphtheria-Tetanus-acellular Pertussis Vaccines

Associated data

ClinicalTrials.gov/NCT01629589