Marta López-Fauqued1, Laura Campora2, Frédérique Delannois3, Mohamed El Idrissi4, Lidia Oostvogels5, Ferdinandus J De Looze6, Javier Diez-Domingo7, Thomas C Heineman8, Himal Lal9, Janet E McElhaney10, Shelly A McNeil11, Wilfred Yeo12, Fernanda Tavares-Da-Silva13. 1. GSK, Wavre, Belgium. Electronic address: marta.x.lopez-fauqed@gsk.com. 2. GSK, Wavre, Belgium. Electronic address: laura.e.campora@gsk.com. 3. GSK, Wavre, Belgium. Electronic address: frederique.x.delannois@gsk.com. 4. GSK, Rixensart, Belgium. Electronic address: mohamed.s.elidrissi@gsk.com. 5. GSK, Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr. 6. AusTrials Pty Ltd, Sherwood and School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: f.delooze@trialworks.com.au. 7. Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain. Electronic address: jdiezdomingo@gmail.com. 8. GSK, King of Prussia, PA, USA. Electronic address: tch3768@gmail.com. 9. GSK, King of Prussia, PA, USA. Electronic address: himallal@yahoo.com. 10. Health Sciences North Research Institute, Sudbury, Ontario, Canada. Electronic address: jmcelhaney@hsnri.ca. 11. Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Shelly.McNeil@nshealth.ca. 12. School of Medicine, University of Wollongong, Wollongong, Australia. Electronic address: wilf@uow.edu.au. 13. GSK, Wavre, Belgium. Electronic address: fernanda.tavares@gsk.com.
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.
RCT Entities:
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.
Authors: Joon Hyung Kim; John Diaz-Decaro; Ning Jiang; Shinn-Jang Hwang; Eun Ju Choo; Maribel Co; Andrew Hastie; David Shu Cheong Hui; Junya Irimajiri; Jacob Lee; Edward Man-Fuk Leung; Haiwen Tang; Tomomi Tsuru; Philip Watson; Zhenhua Wu; Chong-Jen Yu; Yanfei Yuan; Toufik Zahaf; Anthony L Cunningham; Anne Schuind Journal: Hum Vaccin Immunother Date: 2021-02-19 Impact factor: 3.452
Authors: Joseph Fiore; Maribel Miranda Co-van der Mee; Andrés Maldonado; Lisa Glasser; Phil Watson Journal: Ther Adv Vaccines Immunother Date: 2021-11-30
Authors: Marta López-Fauqued; Maribel Co-van der Mee; Adriana Bastidas; Pierre Beukelaers; Alemnew F Dagnew; Juan Jose Fernandez Garcia; Anne Schuind; Fernanda Tavares-da-Silva Journal: Drug Saf Date: 2021-06-11 Impact factor: 5.606
Authors: Kenneth E Schmader; Myron J Levin; Michael Chen; Sean Matthews; Megan E Riley; Wayne Woo; Caroline Hervé; Katrijn Grupping; Anne E Schuind; Lidia Oostvogels; Desmond Curran Journal: J Gerontol A Biol Sci Med Sci Date: 2021-02-25 Impact factor: 6.053
Authors: Alemnew F Dagnew; Nicola P Klein; Caroline Hervé; George Kalema; Emmanuel Di Paolo; James Peterson; Bruno Salaun; Anne Schuind Journal: J Infect Dis Date: 2021-10-13 Impact factor: 5.226