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
Author:
Boutry Céline1, Hastie Andrew2, Diez-Domingo Javier3, Tinoco Juan Carlos4, Yu Chong-Jen5, Andrews Charles6, Beytout Jean7, Caso Covadonga8, Cheng Huey-Shinn9, Cheong Hee Jin10, Choo Eun Ju11, Curiac Dan12, Di Paolo Emmanuel13, Dionne Marc14, Eckermann Tamara15, Esen Meral16, Ferguson Murdo17, Ghesquiere Wayne18, Hwang Shinn-Jang1920, Avelino-Silva Thiago Junqueira21, Kosina Pavel22, Liu Chiu-Shong23, Markkula Jukka24, Moeckesch Beate25, Murta de Oliveira Cláudia26, Park Dae Won27, Pauksens Karlis28, Pirrotta Paola29, Plassmann Georg30, Pretswell Carol31, Rombo Lars32, Salaun Bruno13, Sanmartin Berglund Johan33, Schenkenberger Isabelle34, Schwarz Tino35, Shi Meng2, Ukkonen Benita36, Zahaf Toufik29, Zerbini Cristiano37, Schuind Anne2, Cunningham Anthony L3839, Adams Michael, Ahonen Anitta, Athan Eugene, Barba-Gómez Jose-Fernando, Barbanti Piero, Barberan Elisabeth, Baty Alain, Bengtsson Niklas, Berger-Roscher Juergen, Berndtsson Blom Katarina, Boucher Loïc, Boye Alain, Brault François, Breger Laurie, Brotons Cuixart Carles, Cerna Christine, Cunha Clóvis, Daguzan Benoit, Dahmen Antje, Datta Susan, Giuseppina Desole Maria, Dite Petr, Dutz Jan, Earl John, Ellison William, Eremenko Jurij, Eto Takashi, Farrés Fabré Xavier, Farrington Cecil, André Ferrand Pierre, Finneran Matthew, Francyk David, Freedman Marshall, Freeman George, Gal Peter, Gauthier Jean-Sebastien, Gerlach Beatrice, Gorfinkel Iris, Grigat Christine, Grosskopf Josef, Hamann Monika, Hanrion Pascal, Hartley Paul, Heaton Ken, Himpel-Boenninghoff Agnes, Horacek Thomas, Shu Cheong Hui David, Huong Yieng, Icardi Giancarlo, Illies Gabriele, Irimajiri Junya, Jambrecina Alen, Youl Kim Hyo, Klein Christiane, Kleinecke Uwe, Koenig Hans-Joachim, Kokko Satu, Koskinen Pekka, Kropp Maximilian, Kuroki Rie, Laajalahti Outi, Lachance Pierre, Lee Jacob, Lee Jin-Soo, Levins Peter, Lipetz Robert, Liu Bo, Lundvall Martin, Beth Manning Mary, Martin Frederick, Martínez Piera Pyrene, McNally Damien, McNeil Shelly, Migliorino Guglielmo, Morscher Stephan, Mueller Michael, Kashem Munir Abul, Nakamura Kenjiro, Narejos Pérez Silvia, Naritomi Yuji, Nault Patrice, Luiz Neto José, Núñez López Concepción, Ogata Hiroaki, Olsson Åke, Paavola Pauliina, Patrick Janice, Pérez Vera Mercè, Poder Airi, Poling Terry, Purnell-Mullick Samir, Raad George, Redmond Michael, Remaud Philippe, Riffer Ernie, Robert Patrick, Rodríguez Badia Alex, Luisa Rodríguez de la Pinta Maria, Rosen Robert, Rozen Shari, Saillard Dominique, Sauter Joachim, Schaefer Axel, Schmidt Juergen, Schmitt Bernhard, Schubert Christian, Seppa Ilkka, Kwok Yiu Sha Edmund, Shockey Gerald, Shoffner Sylvia, Sirnela-Rif Elina, Staniscia Tommaso, Sueki Hirohiko, Suzuki Shin, Taminau Denis, Tellier Guy, Terns Riera Manuel, Toma Azhar, Toursarkissian Nicole, Turner Mark, Vilella Morató Anna, Wachter Juergen, Webster Brian, Wilhelm Karl, Wilson Jonathan, Yeo Wilfred, Zahharova Irina,
Affiliation:
1. Aixial, an Alten Company, Brussels, Belgium, C/O GSK, Wavre, Belgium 2. GSK, Rockville, Maryland, USA 3. FISABIO Fundación para el Fomento Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Valencia, Spain 4. Hospital General de Durango, Durango, Mexico 5. Department of Internal Medicine, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan 6. Diagnostics Research Group, San Antonio, Texas, USA 7. Service CIC, CHU Clermont-Ferrand, Clermont-Ferrand, France 8. Servicio de Prevención, Hospital Clínico San Carlos, Madrid, Spain 9. Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan 10. Korea University Guro Hospital, Seoul, Republic of Korea 11. SoonChunhyang University Bucheon Hospital, Bucheon-si, Republic of Korea 12. Clinical Trial Center, SU/Sahlgrenska Universitetssjukhuset, Göteborg, Sweden 13. GSK, Rixensart, Belgium 14. CHU de Québec-Université Laval, Québec City, Canada 15. Praxisgemeinschaft Heimeranplatz, München, Germany 16. Institute of Tropical Medicine, Universitätsklinikum Tübingen, Tübingen, Germany 17. Colchester Research Group, Truro, Canada 18. Division of Infectious Diseases, UBC, Island Health Authority, PerCuro Clinical Research Ltd., Victoria, Canada 19. Taipei Veterans General Hospital, Taipei City, Taiwan 20. National Yang Ming University School of Medicine, Taipei City, Taiwan 21. Laboratório de Investigação Médica em Envelhecimento (LIM-66), Serviço de Geriatria, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil 22. Department of Infectious Diseases, Hradec Kralove, Czechia 23. Occupational Medicine and Family Medicine, China Medical University Hospital, Taichung, Taiwan 24. Pori Vaccine Research Clinic, Vaccine Research Center, Tampere University, Pori, Finland 25. Praxis Dr. med. Beate Moeckesch, Weinheim, Germany 26. Ambulatório de Pesquisa Clínica, Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte, Brazil 27. Korea University Ansan Hospital, Ansan, Republic of Korea 28. Akademiska sjukhuset, Infektionskliniken, Uppsala, Sweden 29. GSK, Wavre, Belgium 30. UHZ Klinische Forschung, Essen, Germany 31. Synexus Lancashire Clinical Research Centre, Chorley, United Kingdom 32. Clinical Research Centre, Eskilstuna, Sweden 33. Blekinge Institute of Technology, Department of Health, Karlstrona, Sweden 34. KFB- Klinische Forschung Berlin, Berlin, Germany 35. Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg, Germany 36. Espoo Vaccine Research Clinic, Vaccine Research Center, Tampere University, Espoo, Finland 37. Centro Paulista de Investigação Clínica, CEPIC, São Paulo, Brazil 38. The Westmead Institute for Medical Research, Westmead, NSW, Australia 39. University of Sydney, Sydney, NSW, Australia
Abstract
Abstract
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.
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
Cited by
49 articles.
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