The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70.
adjuvanted recombinant zoster vaccine
immune response persistence
long-term efficacy
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
28 04 2022
28 04 2022
Historique:
received:
31
03
2021
pubmed:
21
7
2021
medline:
3
5
2022
entrez:
20
7
2021
Statut:
ppublish
Résumé
This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after ≥2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing ≥2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination. Clinical Trials Registration. NCT02723773.
Sections du résumé
BACKGROUND
This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after ≥2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination.
METHODS
Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing ≥2 of 4 assessed activation markers) frequencies from Y5 post-vaccination.
RESULTS
Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels.
CONCLUSIONS
Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination. Clinical Trials Registration. NCT02723773.
Identifiants
pubmed: 34283213
pii: 6324611
doi: 10.1093/cid/ciab629
pmc: PMC9049256
doi:
Substances chimiques
Adjuvants, Immunologic
0
Herpes Zoster Vaccine
0
Vaccines, Synthetic
0
Banques de données
ClinicalTrials.gov
['NCT02723773']
Types de publication
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1459-1467Investigateurs
Michael Adams
(M)
Anitta Ahonen
(A)
Eugene Athan
(E)
Jose-Fernando Barba-Gómez
(JF)
Piero Barbanti
(P)
Elisabeth Barberan
(E)
Alain Baty
(A)
Niklas Bengtsson
(N)
Juergen Berger-Roscher
(J)
Katarina Berndtsson Blom
(K)
Loïc Boucher
(L)
Alain Boye
(A)
François Brault
(F)
Laurie Breger
(L)
Carles Brotons Cuixart
(C)
Christine Cerna
(C)
Clóvis Cunha
(C)
Benoit Daguzan
(B)
Antje Dahmen
(A)
Susan Datta
(S)
Maria Giuseppina Desole
(M)
Petr Dite
(P)
Jan Dutz
(J)
John Earl
(J)
William Ellison
(W)
Jurij Eremenko
(J)
Takashi Eto
(T)
Xavier Farrés Fabré
(X)
Cecil Farrington
(C)
Pierre André Ferrand
(P)
Matthew Finneran
(M)
David Francyk
(D)
Marshall Freedman
(M)
George Freeman
(G)
Peter Gal
(P)
Jean-Sebastien Gauthier
(JS)
Beatrice Gerlach
(B)
Iris Gorfinkel
(I)
Christine Grigat
(C)
Josef Grosskopf
(J)
Monika Hamann
(M)
Pascal Hanrion
(P)
Paul Hartley
(P)
Ken Heaton
(K)
Agnes Himpel-Boenninghoff
(A)
Thomas Horacek
(T)
David Shu Cheong Hui
(D)
Yieng Huong
(Y)
Giancarlo Icardi
(G)
Gabriele Illies
(G)
Junya Irimajiri
(J)
Alen Jambrecina
(A)
Hyo Youl Kim
(H)
Christiane Klein
(C)
Uwe Kleinecke
(U)
Hans-Joachim Koenig
(HJ)
Satu Kokko
(S)
Pekka Koskinen
(P)
Maximilian Kropp
(M)
Rie Kuroki
(R)
Outi Laajalahti
(O)
Pierre Lachance
(P)
Jacob Lee
(J)
Jin-Soo Lee
(JS)
Peter Levins
(P)
Robert Lipetz
(R)
Bo Liu
(B)
Martin Lundvall
(M)
Mary Beth Manning
(M)
Frederick Martin
(F)
Pyrene Martínez Piera
(P)
Damien McNally
(D)
Shelly McNeil
(S)
Guglielmo Migliorino
(G)
Stephan Morscher
(S)
Michael Mueller
(M)
Abul Kashem Munir
(A)
Kenjiro Nakamura
(K)
Silvia Narejos Pérez
(S)
Yuji Naritomi
(Y)
Patrice Nault
(P)
José Luiz Neto
(J)
Concepción Núñez López
(C)
Hiroaki Ogata
(H)
Åke Olsson
(Å)
Pauliina Paavola
(P)
Janice Patrick
(J)
Mercè Pérez Vera
(M)
Airi Poder
(A)
Terry Poling
(T)
Samir Purnell-Mullick
(S)
George Raad
(G)
Michael Redmond
(M)
Philippe Remaud
(P)
Ernie Riffer
(E)
Patrick Robert
(P)
Alex Rodríguez Badia
(A)
Maria Luisa Rodríguez de la Pinta
(M)
Robert Rosen
(R)
Shari Rozen
(S)
Dominique Saillard
(D)
Joachim Sauter
(J)
Axel Schaefer
(A)
Juergen Schmidt
(J)
Bernhard Schmitt
(B)
Christian Schubert
(C)
Ilkka Seppa
(I)
Edmund Kwok Yiu Sha
(E)
Gerald Shockey
(G)
Sylvia Shoffner
(S)
Elina Sirnela-Rif
(E)
Tommaso Staniscia
(T)
Hirohiko Sueki
(H)
Shin Suzuki
(S)
Denis Taminau
(D)
Guy Tellier
(G)
Manuel Terns Riera
(M)
Azhar Toma
(A)
Nicole Toursarkissian
(N)
Mark Turner
(M)
Anna Vilella Morató
(A)
Juergen Wachter
(J)
Brian Webster
(B)
Karl Wilhelm
(K)
Jonathan Wilson
(J)
Wilfred Yeo
(W)
Irina Zahharova
(I)
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.
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