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
Céline Boutry, Andrew Hastie, Javier Díez‐Domingo, Juan Carlos Tinoco, Chong‐Jen Yu, Charles P. Andrews, Jean Beytout, Covadonga Caso, Huey‐Shinn Cheng, Hee Jin Cheong, Eun Ju Choo, Dan Curiac, Emmanuel Di Paolo, Marc Dionne, Tamara Eckermann, Meral Esen, Murdo Ferguson, Wayne Ghesquière, Shinn‐Jang Hwang, Thiago Junqueira Avelino‐Silva, Pavel Kosina, Chiu-Shong Liu, Jukka Markkula, Beate Moeckesch, Cláudia Murta de Oliveira, Dae Won Park, Karlis Pauksens, Paola Pirrotta, Georg Plassmann, Carol Pretswell, Lars Rombo, Bruno Salaun, Johan Berglund, Isabelle Schenkenberger, Tino F. Schwarz, Meng Shi, Benita Ukkonen, Toufik Zahaf, Cristiano A. F. Zerbini, Anne Schuind, Anthony L. Cunningham, Zoster-049 Study Group, Michael A. Adams, Anitta Ahonen, Eugene Athan, Jose-Fernando Barba-Gómez, Piero Barbanti, Elisabeth Barberan, Alain Baty, Niklas Bengtsson, Juergen Berger-Roscher, Katarina Berndtsson Blom, Loïc Boucher, Alain Boye, François Brault, Laurie Breger, Carles Brotons Cuixart, Christine Cerna, Clóvis Cunha, Benoit Daguzan, Antje Dahmen, Susan Datta, Maria Giuseppina Desole, Petr Dítě, Jan Dutz, John Earl, William Ellison, Jurij Eremenko, Takashi Eto, Xavier Farrés Fabré, Cecil Farrington, Pierre André Ferrand, Matthew Finneran, David Francyk, Marshall Freedman, George Freeman, Péter Gál, Jean-Sebastien Gauthier, Beatrice Gerlach, Iris Gorfinkel, Christine Grigat, Josef Großkopf, Mónika Inés Hamann, Pascal Hanrion, Paul Hartley, Ken Heaton, Agnes Himpel-Boenninghoff, Thomas Horacek, David S.C. Hui, Yieng Huong, Giancarlo Icardi, Gabriele Illies, Junya Irimajiri, Alen Jambrecina, Hyo Youl Kim, Christiane Klein, Uwe Kleinecke, Hans-Joachim Koenig, Satu Kokko, Pekka Koskinen
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.