The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial.
Adjuvants, Immunologic
/ administration & dosage
Adult
Antibodies, Bacterial
/ immunology
Antigens, Bacterial
/ immunology
Diphtheria
/ immunology
Diphtheria-Tetanus-acellular Pertussis Vaccines
/ immunology
Female
Herpes Zoster
/ immunology
Herpes Zoster Vaccine
/ immunology
Herpesvirus 3, Human
/ immunology
Humans
Immunization, Secondary
/ methods
Male
Pertussis Vaccine
/ immunology
Tetanus
/ immunology
Vaccines, Synthetic
/ immunology
Viral Vaccines
/ immunology
Whooping Cough
/ immunology
Adjuvanted recombinant zoster vaccine
Co-administration
Herpes zoster
Immune response
Reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Safety
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
16 09 2019
16 09 2019
Historique:
received:
03
04
2019
revised:
30
07
2019
accepted:
01
08
2019
pubmed:
25
8
2019
medline:
22
9
2020
entrez:
25
8
2019
Statut:
ppublish
Résumé
This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years. In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed. VRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups. Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.
Sections du résumé
BACKGROUND
This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years.
METHODS
In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed.
RESULTS
VRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
CONCLUSIONS
Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.
Identifiants
pubmed: 31443993
pii: S0264-410X(19)31026-6
doi: 10.1016/j.vaccine.2019.08.001
pii:
doi:
Substances chimiques
Adjuvants, Immunologic
0
Antibodies, Bacterial
0
Antigens, Bacterial
0
Diphtheria-Tetanus-acellular Pertussis Vaccines
0
Herpes Zoster Vaccine
0
Pertussis Vaccine
0
Vaccines, Synthetic
0
Viral Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT02052596']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
5877-5885Informations de copyright
Copyright © 2019 GSK. Published by Elsevier Ltd.. All rights reserved.