https://orcid.org/0000-0002-9189-4729
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ABSTRACT
As vaccine-induced immunity and protection following natural pertussis infection wane over time, adults and adolescents may develop pertussis and become transmitters to unprotected infants. In Russia, diphtheria and tetanus but not pertussis-containing vaccines are registered for older children, adolescents, or adults. The reduced-antigen-content diphtheria toxoid, tetanus toxoid, and acellular pertussis (dTpa) vaccine (Boostrix, GSK) was developed for booster vaccination of children ≥4 years of age, adolescents, and adults. A phase III, open-label, non-randomized study was performed in eight centers in Russia between January and July 2018. The objective of this study was to assess immunogenicity, reactogenicity and safety of a single dose of dTpa vaccine in healthy Russian participants ≥4 years of age (age categories 4–9 years, 10–17 years, 18–64 years, and ≥65 years). At 1 month post-booster vaccination, across all age groups, >99.0% of participants were seroprotected against diphtheria and tetanus and >96.0% of participants were seropositive for anti-pertussis antibodies. For all antibodies across all age groups, antibody GMCs increased from pre- to 1 month post-booster vaccination and booster responses to diphtheria (in 71.5% of participants), tetanus (85.3%), and pertussis antigens (≥85.6%) were observed. One serious adverse event that was not causally related to the study vaccine was reported. No fatal cases were reported throughout the study period. In conclusion, administration of the dTpa vaccine as a booster dose in healthy Russian participants induced a robust immune response to all vaccine antigens and was generally well tolerated across all age groups.
Abbreviations
| DTP | = | diphtheria, tetanus toxoids and pertussis |
| dTpa | = | reduced-antigen-content diphtheria, tetanus toxoid and acellular pertussis vaccine |
| DTPa | = | diphtheria, tetanus toxoids acellular pertussis |
| D | = | diphtheria toxoid |
| T | = | tetanus toxoid |
| ELISA | = | enzyme-linked immunosorbent assay |
| FHA | = | filamentous hemagglutinin |
| GMC | = | geometric mean concentration |
| GMT | = | geometric mean titer |
| ICH | = | International Conference on Harmonization |
| IU | = | international unit |
| YOA | = | years of age |
| CI | = | confidence interval |
| PRN | = | pertactin |
| PT | = | pertussis toxoid |
| (S)AE | = | (serious) adverse event. |
Acknowledgments
The authors thank Marina Emshanova, Ksenia Savelyeva, Galina Karpova, Geneviève Ramaekers, Elke Geyssens, the nurses, and study participants for their contribution to the study.
The authors thank the Modis platform for editorial assistance and manuscript coordination, on behalf of GSK. Anne-Theres Henze and Botond Nagy provided medical writing support and Camille Turlure coordinated the manuscript development and editorial support.
Disclosure of potential conflicts of interest
AK, LC, LH, MS, MD, NM, NB, PVS, and XS are employed by the GSK group of companies. MS and PVS hold restricted shares in the GSK group of companies as part of their employee remuneration. AA, AG, IO, OS, TL, TM and VR have nothing to declare.
Supplementary material
Supplemental data for this article can be accessed online at http://dx.doi.org/10.1080/21645515.2020.1796423.
Trademark statement
Boostrix is a trademark owned by or licensed to the GSK group of companies.
Data sharing statement
Protocol summary is available at http://www.gsk-clinicalstudyregister.com (study number 201532). For interventional studies that evaluate our medicines, anonymized patient-level data and study documents will be made available to independent researchers, subject to review by an independent panel, at www.clinicalstudydatarequest.com within 6 months of publication. To protect the privacy of patients and individuals involved in our studies, GSK does not publicly disclose patient-level data.