Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults
Himal Lal, Anthony L Cunningham, Olivier Godeaux, Roman Chlibek, Javier Diez-Domingo, Shinn-Jang Hwang, Myron J Levin, Janet E McElhaney, Airi Poder, Joan Puig-Barberà, Timo Vesikari, Daisuke Watanabe, Lily Weckx, Toufik Zahaf, Thomas C Heineman, ZOE-50 Study Group, Mark Arya, Eugene Athan, Anthony L Cunningham, Fred De Looze, John Paul Seale, Wilf Yeo, Luciano Goldani, Wilson Jacob, José Luiz Neto, Rodrigo Ribeiro dos Santos, Lily Weckx, Christiano Zerbini, Jan Dutz, Wayne Ghesquiere, Iris Gorfinkel, Janet E McElhaney, Shelly McNeil, Calvin Powell, Roman Chlibek, Jan Smetana, Airi Poder, Anitta Ahonen, Tiina Korhonen, Ilkka Seppa, Timo Vesikari, Robert Arnou, Jean Beytout, Dominique Saillard, Rolf Dominicus, Meral Esen, Georg Plaßmann, Tino Schwarz, Kerstin Tyler, David Hui, Edward Leung, Angelo Pellegrino, Antonio Volpi, Masahiro Endo, Daisuke Watanabe, Hee Jin Cheong, Won Suk Choi, Eun-Ju Choo, Young Keun Kim, Jin-Soo Lee, Dae Won Park, Kyong Ran Peck, Young Goo Song, Jose-Fernando Barba-Gómez, Abiel Mascareñas de Los Santos, Juan Carlos Tinoco, Jose M Bayas, Covadonga Caso, José Luis Fernández Roure, Lluis Martínez Via, Silvia Narejos Pérez, Concepción Núñez López, Joan Puig-Barberà, Ma Luisa Rodríguez de la Pinta, Manuel Terns Riera, Javier Diez-Domingo, Malin Bengnér, Johan Berglund, Katarina Berndtsson Blom, Bo Liu, Karlis Pauksens, Lars Rombo, Ming-Fong Chen, Huey-Shinn Cheng, Shinn-Jang Hwang, Chiu-Shong Liu, Damien McNally, Alexander Thompson, Charles Andrews, Harry Collins, H Jackson Downey, Jed Ervin, Marshall Freedman, John Hoekstra, Steven Hull, Myron Levin, Isaac Marcadis, Bruce Rankin, Martin Van Cleeff, Himal Lal, Anthony L Cunningham, Olivier Godeaux, Roman Chlibek, Javier Diez-Domingo, Shinn-Jang Hwang, Myron J Levin, Janet E McElhaney, Airi Poder, Joan Puig-Barberà, Timo Vesikari, Daisuke Watanabe, Lily Weckx, Toufik Zahaf, Thomas C Heineman, ZOE-50 Study Group, Mark Arya, Eugene Athan, Anthony L Cunningham, Fred De Looze, John Paul Seale, Wilf Yeo, Luciano Goldani, Wilson Jacob, José Luiz Neto, Rodrigo Ribeiro dos Santos, Lily Weckx, Christiano Zerbini, Jan Dutz, Wayne Ghesquiere, Iris Gorfinkel, Janet E McElhaney, Shelly McNeil, Calvin Powell, Roman Chlibek, Jan Smetana, Airi Poder, Anitta Ahonen, Tiina Korhonen, Ilkka Seppa, Timo Vesikari, Robert Arnou, Jean Beytout, Dominique Saillard, Rolf Dominicus, Meral Esen, Georg Plaßmann, Tino Schwarz, Kerstin Tyler, David Hui, Edward Leung, Angelo Pellegrino, Antonio Volpi, Masahiro Endo, Daisuke Watanabe, Hee Jin Cheong, Won Suk Choi, Eun-Ju Choo, Young Keun Kim, Jin-Soo Lee, Dae Won Park, Kyong Ran Peck, Young Goo Song, Jose-Fernando Barba-Gómez, Abiel Mascareñas de Los Santos, Juan Carlos Tinoco, Jose M Bayas, Covadonga Caso, José Luis Fernández Roure, Lluis Martínez Via, Silvia Narejos Pérez, Concepción Núñez López, Joan Puig-Barberà, Ma Luisa Rodríguez de la Pinta, Manuel Terns Riera, Javier Diez-Domingo, Malin Bengnér, Johan Berglund, Katarina Berndtsson Blom, Bo Liu, Karlis Pauksens, Lars Rombo, Ming-Fong Chen, Huey-Shinn Cheng, Shinn-Jang Hwang, Chiu-Shong Liu, Damien McNally, Alexander Thompson, Charles Andrews, Harry Collins, H Jackson Downey, Jed Ervin, Marshall Freedman, John Hoekstra, Steven Hull, Myron Levin, Isaac Marcadis, Bruce Rankin, Martin Van Cleeff
Abstract
Background: In previous phase 1-2 clinical trials involving older adults, a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01B adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response.
Methods: We conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (≥50 years of age), stratified according to age group (50 to 59, 60 to 69, and ≥70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults.
Results: A total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P<0.001). Vaccine efficacy was between 96.6% and 97.9% for all age groups. Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group. There were solicited or unsolicited reports of grade 3 symptoms in 17.0% of vaccine recipients and 3.2% of placebo recipients. The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups.
Conclusions: The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.gov number, NCT01165177.).
Source: PubMed