Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials
David O Willer, Lidia Oostvogels, Anthony L Cunningham, Pierre Gervais, Iris Gorfinkel, Joon Hyung Kim, Carla Talarico, Valentine Wascotte, Toufik Zahaf, Romulo Colindres, Anne Schuind, ZOE 50/70 study groups, Anitta Ahonen, Charles Andrews, Eugene Athan, Thiago Junqueira Avelino-Silva, Jose-Fernando Barba-Gomez, Johan Berglund, Carles Brotons Cuixart, Covadonga Caso, Roman Chlibek, Won Suk Choi, Ferdinandus de Looze, Maria Giuseppina Desole, Javier Diez Domingo, Jackson H Downey, Peter Eizenberg, Meral Esen, Wayne Ghesquiere, David Shu Cheong Hui, Shinn-Jang Hwang, Hideyuki Ikematsu, Robert W Johnson, Tiina Korhonen, Edward Leung, Myron Levin, Abiel Mascarenas de Los Santos, Janet McElhaney, Shelly McNeil, Silvia Narejos Perez, Karlis Pauksens, Angelo Pellegrino, Airi Poder, Joan Puig Barbera, Rodrigo Ribeiro Dos Santos, Maria Luisa Rodriguez de la Pinta, Lars Rombo, Tino F Schwarz, Ilkka Seppa, Jan Smetana, Tommaso Staniscia, Alexander Thompson, Juan Carlos Tinoco, Azhar Toma, Daisuke Watanabe, Lily Weckx, Yeo Wilfred, David O Willer, Lidia Oostvogels, Anthony L Cunningham, Pierre Gervais, Iris Gorfinkel, Joon Hyung Kim, Carla Talarico, Valentine Wascotte, Toufik Zahaf, Romulo Colindres, Anne Schuind, ZOE 50/70 study groups, Anitta Ahonen, Charles Andrews, Eugene Athan, Thiago Junqueira Avelino-Silva, Jose-Fernando Barba-Gomez, Johan Berglund, Carles Brotons Cuixart, Covadonga Caso, Roman Chlibek, Won Suk Choi, Ferdinandus de Looze, Maria Giuseppina Desole, Javier Diez Domingo, Jackson H Downey, Peter Eizenberg, Meral Esen, Wayne Ghesquiere, David Shu Cheong Hui, Shinn-Jang Hwang, Hideyuki Ikematsu, Robert W Johnson, Tiina Korhonen, Edward Leung, Myron Levin, Abiel Mascarenas de Los Santos, Janet McElhaney, Shelly McNeil, Silvia Narejos Perez, Karlis Pauksens, Angelo Pellegrino, Airi Poder, Joan Puig Barbera, Rodrigo Ribeiro Dos Santos, Maria Luisa Rodriguez de la Pinta, Lars Rombo, Tino F Schwarz, Ilkka Seppa, Jan Smetana, Tommaso Staniscia, Alexander Thompson, Juan Carlos Tinoco, Azhar Toma, Daisuke Watanabe, Lily Weckx, Yeo Wilfred
Abstract
Background: Herpes zoster (HZ) risk appears to vary by sex and geographic ancestry/ethnicity.
Methods: In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart. In this post-hoc analysis, we investigate efficacy of RZV against HZ and postherpetic neuralgia (PHN) by sex, geographic region, and geographic ancestry/ethnicity in ≥50-year-olds (ZOE-50: NCT01165177) and ≥70-year-olds (pooled data from ZOE-50 and ZOE-70: NCT01165229).
Results: Vaccine efficacy against HZ or PHN was similar in women and men. Across geographic regions, efficacy against HZ ranged between 95.7 and 97.2% in ≥50-year-olds, and between 87.3% and 95.1% in ≥70-year-olds; efficacy against PHN ranged between 86.8 and 100% in ≥70-year-olds. Across ancestral/ethnic groups, efficacy ranged between 88.1 and 100% against HZ and between 65.9 and 100% against PHN in ≥70-year-olds.
Conclusions: While the ZOE-50/70 studies were not powered or pre-designed for these post-hoc analyses, RZV appears efficacious against HZ and PHN irrespective of sex, region, or geographic ancestry/ethnicity.
Keywords: Efficacy; Geographic ancestry/ethnicity; Herpes zoster; Recombinant zoster vaccine; Region; Sex.
Copyright © 2019 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed