Clinical Trial

.2016 Sep 15;375(11):1019-32.

doi: 10.1056/NEJMoa1603800.

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Anthony L Cunningham¹, Himal Lal¹, Martina Kovac¹, Roman Chlibek¹, Shinn-Jang Hwang¹, Javier Díez-Domingo¹, Olivier Godeaux¹, Myron J Levin¹, Janet E McElhaney¹, Joan Puig-Barberà¹, Carline Vanden Abeele¹, Timo Vesikari¹, Daisuke Watanabe¹, Toufik Zahaf¹, Anitta Ahonen¹, Eugene Athan¹, Jose F Barba-Gomez¹, Laura Campora¹, Ferdinandus de Looze¹, H Jackson Downey¹, Wayne Ghesquiere¹, Iris Gorfinkel¹, Tiina Korhonen¹, Edward Leung¹, Shelly A McNeil¹, Lidia Oostvogels¹, Lars Rombo¹, Jan Smetana¹, Lily Weckx¹, Wilfred Yeo¹, Thomas C Heineman¹; ZOE-70 Study Group

Collaborators, Affiliations

Collaborators

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

Affiliation

¹ From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia; GSK Vaccines, King of Prussia, PA (H.L., T.C.H.); GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.); Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.); the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.); the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.); the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.); Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada; Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.); the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.); Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.); Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.); the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.); Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.); and

PMID:27626517
DOI: 10.1056/NEJMoa1603800

Free article

Clinical Trial

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Anthony L Cunningham et al. N Engl J Med.2016.

Free article

.2016 Sep 15;375(11):1019-32.

doi: 10.1056/NEJMoa1603800.

Authors

Collaborators

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

Affiliation

¹ From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia; GSK Vaccines, King of Prussia, PA (H.L., T.C.H.); GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.); Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.); the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.); the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.); the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.); Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada; Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.); the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.); Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.); Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.); the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.); Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.); and

PMID:27626517
DOI: 10.1056/NEJMoa1603800

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 andNCT01165229 .).

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Comment in

Preventing Shingles and Its Complications in Older Persons.
Neuzil KM, Griffin MR.Neuzil KM, et al.N Engl J Med. 2016 Sep 15;375(11):1079-80. doi: 10.1056/NEJMe1610652.N Engl J Med. 2016.PMID:27626522No abstract available.
In adults ≥ 70 years of age, an adjuvanted herpes zoster subunit vaccine reduced herpes zoster at a mean 3.7 years.
Sacks HS.Sacks HS.Ann Intern Med. 2017 Jan 17;166(2):JC5. doi: 10.7326/ACPJC-2017-166-2-005.Ann Intern Med. 2017.PMID:28114461No abstract available.
[Herpes zoster vaccination efficacy in adults 70 years of age or older : ZOE-70 study].
Salzberger B, Nitschmann S.Salzberger B, et al.Internist (Berl). 2017 May;58(5):522-524. doi: 10.1007/s00108-017-0222-3.Internist (Berl). 2017.PMID:28357465German.No abstract available.

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Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

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Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

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