Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients
Josephine Ocran-Appiah, Céline Boutry, Caroline Hervé, Jyoti Soni, Anne Schuind, ZOSTER-056 Study Group, Åke Olsson, Ahonen Anitta, Aldea Novo Marta, Andrews Charles, Arya Mark, Athan Eugene, Barba-Gómez Jose-Fernando, Barbanti Piero, Bengtsson Niklas, Berger-Roscher Juergen, Berglund Johan Sanmartin, Berndtsson Blom Katarina, Beytout Jean, Brotons Cuixart Carles, Caso Covadonga, Chlibeck Roman, Choo Eun-Ju, Cunningham Anthony L, Curiac Dan, Dahmen Antje, Datta Susan, Looze de Ferdinandus, Desole Maria Giuseppina, Diez-Domingo Javier, Dionne Marc, Dominicus Rolf, Downey Herman Jackson, Eckermann Tamara, Eizenberg Peter, Ellison William, Ervin John, Esen Meral, Eto Takashi, Ferguson Murdo, Ferrera Giuseppe, Finneran Matthew, Forsten Aino, Freire Antônio Tarcísio, Gauthier Jean-Sebastien, Geller Steven, Gerlach Beatrice, Ghesquiere Wayne, Goldani Luciano, Gorfinkel Iris, Grigat Christine, Grosskopf Josef, Hartley Paul, Heaton Ken, Hoeltz-Roehrig Susanne, Horacek Thomas, Houle Pierre-Alain, Houser Patricia, Hui David Shu Cheong, Huong Yieng, Hwang Shinn-Jang, Icardi Giancarlo, Irimajiri Junya, Jacob Wilson, Jung Thomas, Kim Hyo Youl, Klaff Leslie, Koenig Hans-Joachim, Kokko Satu, Koskinen Pekka, Kuroki Rie, Lachance Pierre, Lee Jacob, Lee Jin-Soo, Levin Michael, Linnhoff Anneliese, Lipetz Robert, Liu Bo, Lundvall Martin, Malempati Srikanth, Manning Mary Beth, Mascareñas de Los Santos Abiel, McNally Damien, McNeil Shelly, Migliorino Guglielmo, Moeckesch Beate, Mueller Michael, Munir Abul Kashem, Nakamura Kenjiro, Narejos Pérez Silvia, Naritomi Yuji, Núñez López Concepción, Ogata Hiroaki, Park Dae Won, Patrick Janice, Pauksens Karlis, Pérez Vera Mercè, Plassmann Georg, Poder Airi, Poling Terry, Powell Calvin, Powell Stephanie, Rodríguez de la Pinta Maria Luisa, Rombo Lars, Rosen Robert, Sauter Joachim, Schaefer Axel, Schenkenberger Isabelle, Schmidt Juergen, Schmitt Bernhard, Schubert Christian, Schwarz Tino, Scott John, Seppa Ilkka, Sha Edmund Kwok Yiu, Song Young Goo, Staniscia Tommaso, Stockhausen Juergen, Sueki Hirohiko, Suzuki Shin, Tellier Guy, Tinoco Juan Carlos, Toma Azhar, Toursarkissian Nicole, Virta Miia, Wachter Juergen, Weckx Lily, Wilson Jonathan, Yeo Wilfred, Yunes Elsa Maria, Zahharova Irina, Josephine Ocran-Appiah, Céline Boutry, Caroline Hervé, Jyoti Soni, Anne Schuind, ZOSTER-056 Study Group, Åke Olsson, Ahonen Anitta, Aldea Novo Marta, Andrews Charles, Arya Mark, Athan Eugene, Barba-Gómez Jose-Fernando, Barbanti Piero, Bengtsson Niklas, Berger-Roscher Juergen, Berglund Johan Sanmartin, Berndtsson Blom Katarina, Beytout Jean, Brotons Cuixart Carles, Caso Covadonga, Chlibeck Roman, Choo Eun-Ju, Cunningham Anthony L, Curiac Dan, Dahmen Antje, Datta Susan, Looze de Ferdinandus, Desole Maria Giuseppina, Diez-Domingo Javier, Dionne Marc, Dominicus Rolf, Downey Herman Jackson, Eckermann Tamara, Eizenberg Peter, Ellison William, Ervin John, Esen Meral, Eto Takashi, Ferguson Murdo, Ferrera Giuseppe, Finneran Matthew, Forsten Aino, Freire Antônio Tarcísio, Gauthier Jean-Sebastien, Geller Steven, Gerlach Beatrice, Ghesquiere Wayne, Goldani Luciano, Gorfinkel Iris, Grigat Christine, Grosskopf Josef, Hartley Paul, Heaton Ken, Hoeltz-Roehrig Susanne, Horacek Thomas, Houle Pierre-Alain, Houser Patricia, Hui David Shu Cheong, Huong Yieng, Hwang Shinn-Jang, Icardi Giancarlo, Irimajiri Junya, Jacob Wilson, Jung Thomas, Kim Hyo Youl, Klaff Leslie, Koenig Hans-Joachim, Kokko Satu, Koskinen Pekka, Kuroki Rie, Lachance Pierre, Lee Jacob, Lee Jin-Soo, Levin Michael, Linnhoff Anneliese, Lipetz Robert, Liu Bo, Lundvall Martin, Malempati Srikanth, Manning Mary Beth, Mascareñas de Los Santos Abiel, McNally Damien, McNeil Shelly, Migliorino Guglielmo, Moeckesch Beate, Mueller Michael, Munir Abul Kashem, Nakamura Kenjiro, Narejos Pérez Silvia, Naritomi Yuji, Núñez López Concepción, Ogata Hiroaki, Park Dae Won, Patrick Janice, Pauksens Karlis, Pérez Vera Mercè, Plassmann Georg, Poder Airi, Poling Terry, Powell Calvin, Powell Stephanie, Rodríguez de la Pinta Maria Luisa, Rombo Lars, Rosen Robert, Sauter Joachim, Schaefer Axel, Schenkenberger Isabelle, Schmidt Juergen, Schmitt Bernhard, Schubert Christian, Schwarz Tino, Scott John, Seppa Ilkka, Sha Edmund Kwok Yiu, Song Young Goo, Staniscia Tommaso, Stockhausen Juergen, Sueki Hirohiko, Suzuki Shin, Tellier Guy, Tinoco Juan Carlos, Toma Azhar, Toursarkissian Nicole, Virta Miia, Wachter Juergen, Weckx Lily, Wilson Jonathan, Yeo Wilfred, Yunes Elsa Maria, Zahharova Irina
Abstract
Background: Efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster (HZ) was demonstrated in pivotal trials ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). This study was designed to offer RZV to placebo recipients of these parent studies.
Methods: Vaccine safety and suspected HZ episode occurrence were assessed for 12 months following vaccination.
Results: Of the 14,550 eligible participants, 8687 received RZV and 97.8% completed the 2-dose schedule. During the 30-day post-vaccination period, 5175 (59.6%) participants experienced ≥ 1 unsolicited adverse event (AE), 4422 (50.9%) were vaccination-related. The most common AEs were injection-site reactions, pyrexia, and headache. During the study, 734 (8.4%) participants reported ≥ 1 serious AE (SAE) and 62 (0.7%) reported ≥ 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related. Suspected HZ episodes were reported by 30 participants (0.3%).
Conclusions: Nature and incidence of AEs, SAEs, and pIMDs were as expected and in line with the parent studies.
Keywords: Adjuvanted recombinant zoster vaccine; Cross-vaccination; Herpes Zoster; Safety.
Conflict of interest statement
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Caroline Hervé, Josephine Ocran-Appiah, Anne Schuind, and Jyoti Soni were employees of the GSK group of companies at the time this study was designed, initiated, and/or conducted. Caroline Hervé is currently an employee of UCB Pharma. Anne Schuind holds shares in the GSK group of companies as part of her remuneration. Céline Boutry is a paid consultant at Aixial an Alten Company, serving as a Clinical Research and Development Lead on behalf of the GSK group of companies.
Copyright © 2020 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed