Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination

Ana Strezova, Javier Diez-Domingo, Kamal Al Shawafi, Juan Carlos Tinoco, Meng Shi, Paola Pirrotta, Agnes Mwakingwe-Omari, Zoster-049 Study Group, Michael Adams, Anitta Ahonen, Charles Andrews, Eugene Athan, Jose-Fernando BarbaGómez, Piero Barbanti, Elisabeth Barberan, Alain Baty, Niklas Bengtsson, Juergen Berger-Roscher, Katarina Berndtsson Blom, Jean Beytout, Loïc Boucher, Céline Boutry, Alain Boye, François Brault, Laurie Breger, Carles Brotons Cuixart, Covadonga Caso, Christine Cerna, Huey-Shinn Cheng, Hee Jin Cheong, Eun Ju Choo, Clóvis Cunha, Anthony L Cunningham, Dan Curiac, Benoit Daguzan, Antje Dahmen, Susan Datta, Maria Giuseppina Desole, Emmanuel Di Paolo, Marc Dionne, Petr Dite, Jan Dutz, John Earl, Tamara Eckermann, William Ellison, Jurij Eremenko, Meral Esen, Takashi Eto, Xavier Farrés Fabré, Cecil Farrington, Murdo Ferguson, Pierre André Ferrand, Matthew Finneran, David Francyk, Marshall Freedman, George Freeman, Antônio Tarcísio Freire, Peter Gal, Jean-Sebastien Gauthier, Beatrice Gerlach, Wayne Ghesquiere, Iris Gorfinkel, Christine Grigat, Josef Grosskopf, Monika Hamann, Pascal Hanrion, Paul Hartley, Andrew Hastie, Ken Heaton, Agnes Himpel-Boenninghoff, Thomas Horacek, David Shu Cheong Hui, Yieng Huong, Shinn-Jang Hwang, Giancarlo Icardi, Gabriele Illies, Junya Irimajiri, Wilson Jacob, Alen Jambrecina, Thiago Junqueira Avelino-Silva, George Kalema, Hyo Youl Kim, Christiane Klein, Uwe Kleinecke, Hans-Joachim Koenig, Satu Kokko, Pavel Kosina, Susanna Koski, Pekka Koskinen, Maximilian Kropp, Rie Kuroki, Outi Laajalahti, Pierre Lachance, Jacob Lee, Jin-Soo Lee, Peter Levins, Robert Lipetz, Bo Liu, Chiu-Shong Liu, Martin Lundvall, Luci Magimaiseelan, Mary Beth Manning, Jukka Markkula, Frederick Martin, Pyrene Martínez Piera, Damien McNally, Shelly McNeil, Guglielmo Migliorino, Beate Moeckesch, Stephan Morscher, Michael Mueller, Abul Kashem Munir, Cláudia Murta de Oliveira, Kenjiro Nakamura, Silvia Narejos Pérez, Yuji Naritomi, Patrice Nault, José Luiz Neto, Concepción Núñez López, Hiroaki Ogata, Åke Olsson, Pauliina Paavola, Dae Won Park, Janice Patrick, Karlis Pauksens, Mercè Pérez Vera, Lauri Peltonen, Georg Plassmann, Airi Poder, Terry Poling, Carol Pretswell, Samir Purnell-Mullick, George Raad, Michael Redmond, Philippe Remaud, Ernie Riffer, Patrick Robert, Alex Rodríguez Badia, Maria Luisa Rodríguez de la Pinta, Lars Rombo, Robert Rosen, Shari Rozen, Dominique Saillard, Bruno Salaun, Johan Sanmartin Berglund, Joachim Sauter, Axel Schaefer, Isabelle Schenkenberger, Juergen Schmidt, Bernhard Schmitt, Christian Schubert, Anne Schuind, Tino Schwarz, Ilkka Seppa, Edmund Kwok Yiu Sha, Gerald Shockey, Sylvia Shoffner, Elina Sirnela-Rif, Tommaso Staniscia, Hirohiko Sueki, Shin Suzuki, Denis Taminau, Guy Tellier, Manuel Terns Riera, Azhar Toma, Nicole Toursarkissian, Mark Turner, Benita Ukkonen, Anna Vilella Morató, Juergen Wachter, Brian Webster, Karl Wilhelm, Jonathan Wilson, Wilfred Yeo, Chong-Jen Yu, Toufik Zahaf, Irina Zahharova, Cristiano Zerbini, Ana Strezova, Javier Diez-Domingo, Kamal Al Shawafi, Juan Carlos Tinoco, Meng Shi, Paola Pirrotta, Agnes Mwakingwe-Omari, Zoster-049 Study Group, Michael Adams, Anitta Ahonen, Charles Andrews, Eugene Athan, Jose-Fernando BarbaGómez, Piero Barbanti, Elisabeth Barberan, Alain Baty, Niklas Bengtsson, Juergen Berger-Roscher, Katarina Berndtsson Blom, Jean Beytout, Loïc Boucher, Céline Boutry, Alain Boye, François Brault, Laurie Breger, Carles Brotons Cuixart, Covadonga Caso, Christine Cerna, Huey-Shinn Cheng, Hee Jin Cheong, Eun Ju Choo, Clóvis Cunha, Anthony L Cunningham, Dan Curiac, Benoit Daguzan, Antje Dahmen, Susan Datta, Maria Giuseppina Desole, Emmanuel Di Paolo, Marc Dionne, Petr Dite, Jan Dutz, John Earl, Tamara Eckermann, William Ellison, Jurij Eremenko, Meral Esen, Takashi Eto, Xavier Farrés Fabré, Cecil Farrington, Murdo Ferguson, Pierre André Ferrand, Matthew Finneran, David Francyk, Marshall Freedman, George Freeman, Antônio Tarcísio Freire, Peter Gal, Jean-Sebastien Gauthier, Beatrice Gerlach, Wayne Ghesquiere, Iris Gorfinkel, Christine Grigat, Josef Grosskopf, Monika Hamann, Pascal Hanrion, Paul Hartley, Andrew Hastie, Ken Heaton, Agnes Himpel-Boenninghoff, Thomas Horacek, David Shu Cheong Hui, Yieng Huong, Shinn-Jang Hwang, Giancarlo Icardi, Gabriele Illies, Junya Irimajiri, Wilson Jacob, Alen Jambrecina, Thiago Junqueira Avelino-Silva, George Kalema, Hyo Youl Kim, Christiane Klein, Uwe Kleinecke, Hans-Joachim Koenig, Satu Kokko, Pavel Kosina, Susanna Koski, Pekka Koskinen, Maximilian Kropp, Rie Kuroki, Outi Laajalahti, Pierre Lachance, Jacob Lee, Jin-Soo Lee, Peter Levins, Robert Lipetz, Bo Liu, Chiu-Shong Liu, Martin Lundvall, Luci Magimaiseelan, Mary Beth Manning, Jukka Markkula, Frederick Martin, Pyrene Martínez Piera, Damien McNally, Shelly McNeil, Guglielmo Migliorino, Beate Moeckesch, Stephan Morscher, Michael Mueller, Abul Kashem Munir, Cláudia Murta de Oliveira, Kenjiro Nakamura, Silvia Narejos Pérez, Yuji Naritomi, Patrice Nault, José Luiz Neto, Concepción Núñez López, Hiroaki Ogata, Åke Olsson, Pauliina Paavola, Dae Won Park, Janice Patrick, Karlis Pauksens, Mercè Pérez Vera, Lauri Peltonen, Georg Plassmann, Airi Poder, Terry Poling, Carol Pretswell, Samir Purnell-Mullick, George Raad, Michael Redmond, Philippe Remaud, Ernie Riffer, Patrick Robert, Alex Rodríguez Badia, Maria Luisa Rodríguez de la Pinta, Lars Rombo, Robert Rosen, Shari Rozen, Dominique Saillard, Bruno Salaun, Johan Sanmartin Berglund, Joachim Sauter, Axel Schaefer, Isabelle Schenkenberger, Juergen Schmidt, Bernhard Schmitt, Christian Schubert, Anne Schuind, Tino Schwarz, Ilkka Seppa, Edmund Kwok Yiu Sha, Gerald Shockey, Sylvia Shoffner, Elina Sirnela-Rif, Tommaso Staniscia, Hirohiko Sueki, Shin Suzuki, Denis Taminau, Guy Tellier, Manuel Terns Riera, Azhar Toma, Nicole Toursarkissian, Mark Turner, Benita Ukkonen, Anna Vilella Morató, Juergen Wachter, Brian Webster, Karl Wilhelm, Jonathan Wilson, Wilfred Yeo, Chong-Jen Yu, Toufik Zahaf, Irina Zahharova, Cristiano Zerbini

Abstract

Approximately 10 years after vaccination with the recombinant zoster vaccine (RZV), an interim analysis of this follow-up study of the ZOE-50/70 trials demonstrated that efficacy against herpes zoster remained high. Moreover, the safety profile remained clinically acceptable, suggesting that the clinical benefit of the RZV in ≥50-year-olds is sustained up to 10 years.

Keywords: adjuvanted recombinant zoster vaccine; immune response persistence; long-term efficacy; long-term safety.

Conflict of interest statement

Potential conflicts of interest. K.A.S. is a Modis employee, working on behalf of the GSK group of companies. A.M.O., M.S., A.S., and P.P. are employees of the GSK group of companies. P.P. and A.S. hold shares/stocks in the GSK group of companies as part of their employee remuneration. J.D.D. reports grants from the GSK group of companies, Sanofi, and MSD; consulting fees from Sanofi Pasteur and MSD paid to him and his institution; honoraria from the GSK group of companies and SEQIRUS (to him and his institution), outside the submitted work. J.C.T. reports grant/research support from the GSK group of companies. The authors have no other financial or nonfinancial interests to declare. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Persistence of humoral (A) and cell-mediated (B) immune responses to RZV up to the second interim analysis of ZOE-LTFU (ATP cohort for persistence). aPrevaccination values from all RZV recipients in the humoral immunogenicity/CMI subsets in ZOE-50 and ZOE-70 [6]. Year 5 data for CD4[2+] T-cell frequencies are not shown because only 3 participants had available results for this analysis. bAt the data lock point for the second interim analysis in ZOE-LTFU, data collection for year 10 was still incomplete. Abbreviations: ATP, according-to-protocol; CI, confidence interval; CMI, cell-mediated immunity; gE, glycoprotein E; GMC, geometric mean concentration; CD4[2+] T cells, CD4+ T cells expressing at least 2 of 4 assessed activation markers (interferon-γ, interleukin-2, tumor necrosis factor–α, and CD40 ligand) per 106 CD4+ T cells; Q1 and Q3, first and third quartiles, respectively; mIU/mL, milli-International Units per milliliter; N, number of participants with available results; RZV, adjuvanted recombinant zoster vaccine; ZOE-LTFU, long-term follow-up study of ZOE-50/70.

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Source: PubMed

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