Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older
Anthony L Cunningham, Himal Lal, Martina Kovac, Roman Chlibek, Shinn-Jang Hwang, Javier Díez-Domingo, Olivier Godeaux, Myron J Levin, Janet E McElhaney, Joan Puig-Barberà, Carline Vanden Abeele, Timo Vesikari, Daisuke Watanabe, Toufik Zahaf, Anitta Ahonen, Eugene Athan, Jose F Barba-Gomez, Laura Campora, Ferdinandus de Looze, H Jackson Downey, Wayne Ghesquiere, Iris Gorfinkel, Tiina Korhonen, Edward Leung, Shelly A McNeil, Lidia Oostvogels, Lars Rombo, Jan Smetana, Lily Weckx, Wilfred Yeo, Thomas C Heineman, ZOE-70 Study Group, Eugene Athan, Anthony L Cunningham, Ferdinandus de Looze, Peter Eizenberg, Wilfred Yeo, Thiago Junquera Avelino-Silva, Jose Luiz Neto, Rodrigo Ribeiro dos Santos, Lily Weckx, Cristiano A F Zerbini, Jean-Sebastien Gauthier, Wayne Ghesquiere, Iris Gorfinkel, Janet E McElhaney, Shelly A McNeil, Azhar Toma, Roman Chlibek, Jan Smetana, Airi Poder, Anitta Ahonen, Aino Forsten, Tiina Karppa, Tiina Korhonen, Ilkka Seppä, Timo Vesikari, Meral Esen, Tino F Schwarz, Edward Leung, Maria Guiseppina Desole, Giancarlo Icardi, Angelo Pellegrino, Tommaso Staniscia, Antonio Volpi, Hideyuki Ikematsu, Daisuke Watanabe, Won Suk Choi, Jose Fernando Barba-Gomez, Abiel Mascarenas de Los Santos, Juan Carlos Tinoco, Carlos Brotons, Cavadonga Caso, Javier Diez-Domingo, Silvia Narejos Perez, Joan Puig-Barberà, Maria Luisa Rodriguez de la Pinta, Johan Berglund, Katarina Berndtsson Blom, Bo Liu, Karlis Pauksens, Lars Rombo, Shinn-Jang Hwang, Alexander Thompson, Charles Andrews, H Jackson Downey, Marshall Freedman, Myron Levin, Mahamadou Boubacar Arbi, Laura Campora, Grégory Catteau, Desmond Curran, Olivier Godeaux, Thomas C Heineman, Martina Kovac, Himal Lal, Sandie Marion, Lidia Oostvogels, Mohamed Oujaa, Stéphanie Ravault, Carline Vanden Abeele, Ilse Vastiau, Toufik Zahaf, Olivier Godeaux, Thomas C Heineman, Himal Lal, Toufik Zahaf, Anitta Ahonen, Charles Andrews, Eugene Athan, Thiago Junqueira, Jose Fernando Barba-Gomez, Johan Berglund, Katarina Berndtsson Blom, Carlos Brotons, Cavadonga Caso, Roman Chlibek, Won Suk Choi, Anthony L Cunningham, Ferdinandus de Looze, Javier Diez-Domingo, H Jackson Downey, Peter Eizenberg, Meral Esen, Aino Forsten, Marshall Freedman, Jean-Sebastien Gauthier, Wayne Ghesquiere, Maria Guiseppina Desole, Shinn-Jang Hwang, Giancarlo Icardi, Hideyuki Ikematsu, Tiina Karppa, Tiina Korhonen, Bo Liu, Abiel Mascarenas de Los Santos, Janet E McElhaney, Shelly A McNeil, Silvia Narejos Perez, Edward Leung, Jose Luiz Neto, Karlis Pauksens, Angelo Pellegrino, Airi Poder, Joan Puig-Barberà, Rodrigo Ribeiro dos Santos, Maria Luisa Rodriguez, Lars Rombo, Tino F Schwarz, Ilkka Seppä, Jan Smetana, Tommaso Staniscia, Alexander Thompson, Juan Carlos Tinoco, Azhar Toma, Timo Vesikari, Antonio Volpi, Lily Weckx, Wilfred Yeo, Cristiano Zerbini, Mahamadou Boubacar Arbi, Grégory Catteau, Desmond Curran, Sandie Marion, Mohamed Oujaa, Carline Vanden Abeele, Toufik Zahaf, Anitta Ahonen, Eugene Athan, Jose Fernando Barba-Gomez, Laura Campora, Roman Chlibek, Anthony L Cunningham, Ferdinandus de Looze, Javier Diez-Domingo, H Jackson Downey, Wayne Ghesquiere, Olivier Godeaux, Iris Gorfinkel, Thomas Heineman, Shinn-Jang Hwang, Tiina Korhonen, Martina Kovac, Himal Lal, Edward Leung, Myron J Levin, Janet E McElhaney, Shelly A McNeil, Lidia Oostvogels, Joan Puig, Stéphanie Ravault, Lars Rombo, Jan Smetana, Carline Vanden Abeele, Ilse Vastiau, Timo Vesikari, Daisuke Watanabe, Lily Weckx, Wilfred Yeo, Toufik Zahaf, Roman Chlibek, Anthony L Cunningham, Javier Diez-Domingo, Thomas Heineman, Shinn-Jang Hwang, Martina Kovac, Himal Lal, Myron J Levin, Janet E McElhaney, Lidia Oostvogels, Joan Puig-Barberà, Thomas C Heineman, Anthony L Cunningham, Himal Lal, Martina Kovac, Roman Chlibek, Shinn-Jang Hwang, Javier Díez-Domingo, Olivier Godeaux, Myron J Levin, Janet E McElhaney, Joan Puig-Barberà, Carline Vanden Abeele, Timo Vesikari, Daisuke Watanabe, Toufik Zahaf, Anitta Ahonen, Eugene Athan, Jose F Barba-Gomez, Laura Campora, Ferdinandus de Looze, H Jackson Downey, Wayne Ghesquiere, Iris Gorfinkel, Tiina Korhonen, Edward Leung, Shelly A McNeil, Lidia Oostvogels, Lars Rombo, Jan Smetana, Lily Weckx, Wilfred Yeo, Thomas C Heineman, ZOE-70 Study Group, Eugene Athan, Anthony L Cunningham, Ferdinandus de Looze, Peter Eizenberg, Wilfred Yeo, Thiago Junquera Avelino-Silva, Jose Luiz Neto, Rodrigo Ribeiro dos Santos, Lily Weckx, Cristiano A F Zerbini, Jean-Sebastien Gauthier, Wayne Ghesquiere, Iris Gorfinkel, Janet E McElhaney, Shelly A McNeil, Azhar Toma, Roman Chlibek, Jan Smetana, Airi Poder, Anitta Ahonen, Aino Forsten, Tiina Karppa, Tiina Korhonen, Ilkka Seppä, Timo Vesikari, Meral Esen, Tino F Schwarz, Edward Leung, Maria Guiseppina Desole, Giancarlo Icardi, Angelo Pellegrino, Tommaso Staniscia, Antonio Volpi, Hideyuki Ikematsu, Daisuke Watanabe, Won Suk Choi, Jose Fernando Barba-Gomez, Abiel Mascarenas de Los Santos, Juan Carlos Tinoco, Carlos Brotons, Cavadonga Caso, Javier Diez-Domingo, Silvia Narejos Perez, Joan Puig-Barberà, Maria Luisa Rodriguez de la Pinta, Johan Berglund, Katarina Berndtsson Blom, Bo Liu, Karlis Pauksens, Lars Rombo, Shinn-Jang Hwang, Alexander Thompson, Charles Andrews, H Jackson Downey, Marshall Freedman, Myron Levin, Mahamadou Boubacar Arbi, Laura Campora, Grégory Catteau, Desmond Curran, Olivier Godeaux, Thomas C Heineman, Martina Kovac, Himal Lal, Sandie Marion, Lidia Oostvogels, Mohamed Oujaa, Stéphanie Ravault, Carline Vanden Abeele, Ilse Vastiau, Toufik Zahaf, Olivier Godeaux, Thomas C Heineman, Himal Lal, Toufik Zahaf, Anitta Ahonen, Charles Andrews, Eugene Athan, Thiago Junqueira, Jose Fernando Barba-Gomez, Johan Berglund, Katarina Berndtsson Blom, Carlos Brotons, Cavadonga Caso, Roman Chlibek, Won Suk Choi, Anthony L Cunningham, Ferdinandus de Looze, Javier Diez-Domingo, H Jackson Downey, Peter Eizenberg, Meral Esen, Aino Forsten, Marshall Freedman, Jean-Sebastien Gauthier, Wayne Ghesquiere, Maria Guiseppina Desole, Shinn-Jang Hwang, Giancarlo Icardi, Hideyuki Ikematsu, Tiina Karppa, Tiina Korhonen, Bo Liu, Abiel Mascarenas de Los Santos, Janet E McElhaney, Shelly A McNeil, Silvia Narejos Perez, Edward Leung, Jose Luiz Neto, Karlis Pauksens, Angelo Pellegrino, Airi Poder, Joan Puig-Barberà, Rodrigo Ribeiro dos Santos, Maria Luisa Rodriguez, Lars Rombo, Tino F Schwarz, Ilkka Seppä, Jan Smetana, Tommaso Staniscia, Alexander Thompson, Juan Carlos Tinoco, Azhar Toma, Timo Vesikari, Antonio Volpi, Lily Weckx, Wilfred Yeo, Cristiano Zerbini, Mahamadou Boubacar Arbi, Grégory Catteau, Desmond Curran, Sandie Marion, Mohamed Oujaa, Carline Vanden Abeele, Toufik Zahaf, Anitta Ahonen, Eugene Athan, Jose Fernando Barba-Gomez, Laura Campora, Roman Chlibek, Anthony L Cunningham, Ferdinandus de Looze, Javier Diez-Domingo, H Jackson Downey, Wayne Ghesquiere, Olivier Godeaux, Iris Gorfinkel, Thomas Heineman, Shinn-Jang Hwang, Tiina Korhonen, Martina Kovac, Himal Lal, Edward Leung, Myron J Levin, Janet E McElhaney, Shelly A McNeil, Lidia Oostvogels, Joan Puig, Stéphanie Ravault, Lars Rombo, Jan Smetana, Carline Vanden Abeele, Ilse Vastiau, Timo Vesikari, Daisuke Watanabe, Lily Weckx, Wilfred Yeo, Toufik Zahaf, Roman Chlibek, Anthony L Cunningham, Javier Diez-Domingo, Thomas Heineman, Shinn-Jang Hwang, Martina Kovac, Himal Lal, Myron J Levin, Janet E McElhaney, Lidia Oostvogels, Joan Puig-Barberà, Thomas C Heineman
Abstract
Background: A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70).
Methods: This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50.
Results: In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups.
Conclusions: In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT01165229 .).
Source: PubMed