Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

for the ZOE-50/70 Study Group

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV.

Original languageEnglish
Pages (from-to)2482-2493
Number of pages12
JournalVaccine
Volume37
Issue number18
DOIs
Publication statusPublished - 2019 Apr 24

Fingerprint

Herpes Zoster Vaccine
Synthetic Vaccines
placebos
vaccines
Safety
Placebos
Immune System Diseases
Vaccination
vaccination
risk profile
Phase III Clinical Trials
injection site
Herpes Zoster
dosage
clinical trials

Keywords

  • Reactogenicity
  • Safety
  • Vaccine
  • Varicella-zoster virus

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials. / for the ZOE-50/70 Study Group.

In: Vaccine, Vol. 37, No. 18, 24.04.2019, p. 2482-2493.

Research output: Contribution to journalArticle

@article{e0420f499755404492a5d1569b2d4f3c,
title = "Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials",
abstract = "Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90{\%} efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5{\%} versus 32.0{\%}); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1{\%}; Placebo: 10.4{\%}), fatal AEs (RZV: 4.3{\%}; Placebo: 4.6{\%}), and pIMDs (RZV: 1.2{\%}; Placebo: 1.4{\%}) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV.",
keywords = "Reactogenicity, Safety, Vaccine, Varicella-zoster virus",
author = "{for the ZOE-50/70 Study Group} and Marta L{\'o}pez-Fauqued and Laura Campora and Fr{\'e}d{\'e}rique Delannois and {El Idrissi}, Mohamed and Lidia Oostvogels and {De Looze}, {Ferdinandus J.} and Javier Diez-Domingo and Heineman, {Thomas C.} and Himal Lal and McElhaney, {Janet E.} and McNeil, {Shelly A.} and Wilfred Yeo and Fernanda Tavares-Da-Silva and Anitta Ahonen and Avelino-Silva, {Thiago Junquera} and Barba-Gomez, {Jose Fernando} and Johan Berglund and Cuixart, {Carlos Brotons} and Covadonga Caso and Roman Chlibek and Wonseok Choi and Cunningham, {Anthony L.} and Desole, {Maria Guiseppina} and Peter Eizenberg and Meral Esen and Emmanuelle Espi{\'e} and Pierre Gervais and Wayne Ghesquiere and Olivier Godeaux and Iris Gorfinkel and Hui, {David Shu Cheong} and Hwang, {Shinn Jang} and Tiina Korhonen and Martina Kovac and Edouard Ledent and Edward Leung and Levin, {Myron J.} and Perez, {Silvia Narejos} and Neto, {Jose Luiz} and Karlis Pauksens and Airi Poder and {de la Pinta}, {Maria Luisa Rodriguez} and Lars Rombo and Schwarz, {Tino F.} and Jan Smetana and Tommaso Staniscia and Tinoco, {Juan Carlos} and Azhar Toma and Ilse Vastiau and Timo Vesikari",
year = "2019",
month = "4",
day = "24",
doi = "10.1016/j.vaccine.2019.03.043",
language = "English",
volume = "37",
pages = "2482--2493",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "18",

}

TY - JOUR

T1 - Safety profile of the adjuvanted recombinant zoster vaccine

T2 - Pooled analysis of two large randomised phase 3 trials

AU - for the ZOE-50/70 Study Group

AU - López-Fauqued, Marta

AU - Campora, Laura

AU - Delannois, Frédérique

AU - El Idrissi, Mohamed

AU - Oostvogels, Lidia

AU - De Looze, Ferdinandus J.

AU - Diez-Domingo, Javier

AU - Heineman, Thomas C.

AU - Lal, Himal

AU - McElhaney, Janet E.

AU - McNeil, Shelly A.

AU - Yeo, Wilfred

AU - Tavares-Da-Silva, Fernanda

AU - Ahonen, Anitta

AU - Avelino-Silva, Thiago Junquera

AU - Barba-Gomez, Jose Fernando

AU - Berglund, Johan

AU - Cuixart, Carlos Brotons

AU - Caso, Covadonga

AU - Chlibek, Roman

AU - Choi, Wonseok

AU - Cunningham, Anthony L.

AU - Desole, Maria Guiseppina

AU - Eizenberg, Peter

AU - Esen, Meral

AU - Espié, Emmanuelle

AU - Gervais, Pierre

AU - Ghesquiere, Wayne

AU - Godeaux, Olivier

AU - Gorfinkel, Iris

AU - Hui, David Shu Cheong

AU - Hwang, Shinn Jang

AU - Korhonen, Tiina

AU - Kovac, Martina

AU - Ledent, Edouard

AU - Leung, Edward

AU - Levin, Myron J.

AU - Perez, Silvia Narejos

AU - Neto, Jose Luiz

AU - Pauksens, Karlis

AU - Poder, Airi

AU - de la Pinta, Maria Luisa Rodriguez

AU - Rombo, Lars

AU - Schwarz, Tino F.

AU - Smetana, Jan

AU - Staniscia, Tommaso

AU - Tinoco, Juan Carlos

AU - Toma, Azhar

AU - Vastiau, Ilse

AU - Vesikari, Timo

PY - 2019/4/24

Y1 - 2019/4/24

N2 - Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV.

AB - Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV.

KW - Reactogenicity

KW - Safety

KW - Vaccine

KW - Varicella-zoster virus

UR - http://www.scopus.com/inward/record.url?scp=85063476515&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85063476515&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2019.03.043

DO - 10.1016/j.vaccine.2019.03.043

M3 - Article

C2 - 30935742

AN - SCOPUS:85063476515

VL - 37

SP - 2482

EP - 2493

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 18

ER -