Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults by Region: Results of the Phase 3 ZOE-50 Trial
Year: 2015
Type: article
Abstract: Background. In the phase 3 ZOE-50 trial, the HZ/su investigational subunit vaccine, containing the varicella-zoster virus glycoprotein E and the AS01B Adjuvant System, overall vaccine efficacy was 97.2% for the prevention of herpes zoster (HZ) in adults ≥50 years of age (Lal et al, 2015 New Engl J Med). The worldwide recruitment of subjects allows for additional analyses by region. Here we present initial results on disease incidence and vaccine efficacy (VE) by study region. Methods. We conducted a randomized, observer-blind, placebo-controlled phase 3 trial in 18 countries in Europe, North America, Latin America, and Asia/Australia to evaluate the efficacy and safety of HZ/su in adults ≥50 years of age. Subjects were randomized 1:1 to receive 2 doses of HZ/su or placebo (saline solution) by intramuscular injection 2 months apart. VE in reducing the incidence of HZ compared to placebo was analyzed in subjects who received two doses and who did not develop a confirmed case of HZ within one month after dose 2 (modified total vaccinated cohort; mTVC). All suspected HZ cases were confirmed by polymerase chain reaction and/or a case adjudication committee. Results. A total of 15,411 evaluable subjects received at least one dose of HZ/su or placebo. Most subjects were from Europe (51.2%), followed by Asia/Australia (21.3%), North America (17.4%), and Latin America (10.1%). After a mean follow-up of 3.2 years, 408 subjects overall presented with a suspected case of HZ, of whom 244 were confirmed as HZ. In the mTVC, 216 subjects had a confirmed case of HZ (HZ/su: 6; placebo: 210). VE against HZ did not differ between study regions, and ranged from 94.6% in Asia/Australia to 98.9% in Europe (table). HZ incidence in the placebo group was lower in Europe than in the other regions (7.5 versus 10.3–11.6 cases per 1000 person-years). Conclusion. HZ/su vaccine efficacy against HZ in adults ≥50 years of age was consistently very high across all study regions. The ZOE-50 trial also allowed us to determine regional HZ incidence based on a thorough and globally consistent disease confirmation method (NCT01165177). Disclosures. A. L. Cunningham, GSK Vaccines: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Merck International: Scientific Advisor, Consulting fee. Bio CSL: Scientific Advisor, Consulting fee; R. Chlibek, GSK Vaccines: Grant Investigator, Consulting fee, Research grant and Speaker honorarium. Pfizer: Grant Investigator and Scientific Advisor, Consulting fee and Speaker honorarium; J. Diez-Domingo, GSK Vaccines: Grant Investigator, Research grant. SPMSD: Grant Investigator and Speaker's Bureau, Research grant and Speaker honorarium. Novartis: Speaker's Bureau, Speaker honorarium; J. F. Barba-Gomez, GSK Vaccines: Grant Investigator, Research grant; S. J. Hwang, GSK Vaccines: Grant Investigator, Research grant; M. Levin, GSK Vaccines: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Merck, Sharp & Dohme: Grant Investigator and Shareholder, Consulting fee, Licensing agreement or royalty and Research grant; J. Smetana, GSK Vaccines: Grant Investigator, Research grant. Sanofi Pasteur: Grant Investigator, Research grant; T. Vesikari, GSK Vaccines: Grant Investigator, Research grant and Speaker honorarium. Merck: Grant Investigator, Research grant and Speaker honorarium. SP MSD: Board Member, Consulting fee; O. Godeaux, GSK Vaccines: Employee and Shareholder, Salary; T. Zahaf, GSK Vaccines: Employee and Shareholder, Salary; H. Lal, GSK Vaccines: Employee and Shareholder, Salary; T. Heineman, GSK Vaccines: Employee and Shareholder, Salary
Source: Open Forum Infectious Diseases
Authors: Anthony L Cunningham, Roman Chlibek, Javier Diez-Domingo, Eugene Athan, Jose-Fernando Barba-Gomez, Wayne Ghesquiere, Shinn-Jang Hwang, Edward Leung, Myron Levin, Airi Poder, Joan Puig-Barbera, Jan Smetana, Timo Vesikari, Antonio Volpi, Olivier Godeaux, Toufik Zahaf, Himal Lal, Thomas Heineman
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,053
OpenAlex ID: W2288364756