Marta Lopez-Fauqued, GSK Vaccines
Laura Campora, GSK Vaccines
Frederique Delannois, GSK Vaccines
Mohamed El Idrissi, GSK Vaccines
Lidia Oostvogels, GSK Vaccines
Ferdinandus J. De Looze, University of Queensland
Javier Diez-Domingo, Fundación Para El Fomento De La Investigación Sanitaria Y Biomédica
Thomas Heineman, GSK Vaccines
Himal Lal, GSK Vaccines
Janet E. Mcelhaney, Health Sciences North Research Institute
Shelly McNeil, Dalhousie University
Wilfred W. Yeo, University of WollongongFollow
Fernanda Tavares-Da-Silva, GSK Vaccines
Anitta Ahonen, University of Tampere
Thiago Avelino-Silva, University of Sao Paulo
Jose Barba-Gomez, Dermatologico Institute of Jalisco
Johan Berglund, Blekinge Institute of Technology
Carlos Cuixart, EAP
Covadonga Caso, Hospital Clínico San Carlos
Roman Chlibek, University of Defense
Won Choi, Korea University College of Medicine
Anthony Cunningham, Korea University College of Medicine
Maria Desole, Public Hygiene Service
Peter Eizenberg, Doctors of Ivanhoe
Meral Esen, University Clinic of Tubingen
Emmanuelle Espie, GSK Vaccines
Pierre Gervais, Q&T Research Sherbrooke
Wayne Ghesquiere, University of British Columbia
Olivier Godeaux, GSK Vaccines
Iris Gorfinkel, York University
David Hui, Prince of Wales Hospital
Shinn-Jang Hwang, Taipei Veterans General Hospital, National Yang Ming University School Of Medicine
Tiina Korhonen, GSK Vaccines
Martina Kovac, GSK Vaccines, University of Queensland
Edouard Ledent, GSK Vaccines, Fundación Para El Fomento De La Investigación Sanitaria Y Biomédica
Edward Leung, GSK Vaccines
Myron J. Levin, GSK Vaccines, Health Sciences North Research Institute
Silvia Perez, GSK Vaccines, Dalhousie University
Jose Neto, GSK Vaccines, University of Wollongong
Karlis Pauksens, University of Tampere, GSK Vaccines
Airi Poder, GSK Vaccines, University of Sao Paulo
Maria de la pinta, Public Hygiene Service, GSK Vaccines
Lars Rombo, Blekinge Institute of Technology, GSK Vaccines
Tino Schwarz, EAP, GSK Vaccines
Jan Smetana, Hospital Clínico San Carlos, GSK Vaccines
Tommaso Staniscia, University of Defence, GSK Vaccines
Juan Tinoco, GSK Vaccines, Korea University College of Medicine
Azhar Toma, GSK Vaccines, University of Sydney
Ilse Vastiau, Public Hygiene Service, GSK Vaccines
Timo Vesikari, GSK Vaccines, Doctors of Ivanhoe
Antonio Volpi, University Clinic of Tubingen, GSK Vaccines
Daisuke Watanabe, GSK Vaccines
Lily Weckx, GSK Vaccines, Q&T Research Sherbrooke
Toufik Zahaf, GSK Vaccines, University of British Columbia



Publication Details

Lopez-Fauqued, M., Campora, L., Delannois, F., El Idrissi, M., Oostvogels, L., De Looze, F. J., Diez-Domingo, J., Heineman, T. C., Lal, H., McElhaney, J. E., McNeil, S. A., Yeo, W., Tavares-Da-Silva, F., Ahonen, A., Avelino-Silva, T. Junquera., Barba-Gomez, J. Fernando., Berglund, J., Cuixart, C. Brotons., Caso, C., Chlibek, R., Choi, W. Suk., Cunningham, A., Desole, M. Guiseppina., Eizenberg, P., Esen, M., Espie, E., Gervais, P., Ghesquiere, W., Godeaux, O., Gorfinkel, I., Hui, D. Shu Cheong., Hwang, S., Korhonen, T., Kovac, M., Ledent, E., Leung, E., Levin, M. J., Perez, S. Narejos., Neto, J. Luiz., Pauksens, K., Poder, A., de la pinta, M. Luisa Rodriguez., Rombo, L., Schwarz, T. F., Smetana, J., Staniscia, T., Tinoco, J. Carlos., Toma, A., Vastiau, I., Vesikari, T., Volpi, A., Watanabe, D., Weckx, L. Yin. & Zahaf, T. (2019). Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine, 37 (18), 2482-2493.


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.



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