1927. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults by region: results of the phase 3 ZOE-50 trial
Session: Poster Abstract Session: Vaccines: Varicella/Zoster
Saturday, October 10, 2015
Room: Poster Hall

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.1 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 (Figure). HZ incidence in the placebo group was lower in Europe than in the other regions (7.5 vs. 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).

References.

1 Lal H, Cunningham TC, Godeaux O, et al. 2015 New Engl J Med


 

 

Anthony L Cunningham, MB BS MD1, Roman Chlibek, MD Ph.D.2, Javier Diez-Domingo, Md Ph.D.3, Eugene Athan, MBBS, FRACP, MPH4, Jose-Fernando Barba-Gomez, MD5, Wayne Ghesquiere, MD FRCPC6, Shinn-Jang Hwang, MD7, Edward Leung, MD8, Myron Levin, MD, FIDSA9, Airi Poder, MD10, Joan Puig-Barbera, MD Ph.D.3, Jan Smetana, MD Ph.D.2, Timo Vesikari, MD, PhD11, Antonio Volpi, MD12, Olivier Godeaux, MD13, Toufik Zahaf, Ph.D.13, Himal Lal, MD14 and Thomas Heineman, MD, PhD14, (1)Westmead Millennium Institute for Medical Research, Westmead, Australia, (2)Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic, (3)Centre for Public Health Research, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain, (4)Infectious Diseases, Barwon Health, Deakin University, Geelong, Australia, (5)Instituto Dermatológico de Jalisco, Jalisco, Mexico, (6)Royal Jubilee Hospital and Victoria General Hospital, Victoria, BC, Canada, (7)Taipei Veterans General Hospital; National Yang Ming University School of Medicine, Taipei, Taiwan, (8)Department of Medicine, United Christian Hospital, Kowloon, Hong Kong, (9)Pediatrics & Medicine, University of Colorado Denver School of Medicine, Aurora, CO, (10)Tartu University Hospital, Tartu, Estonia, (11)Tampere Vaccine Research Centre, University of Tampere, Tampere, Finland, (12)Universitŕ di Roma Tor Vergata, Rome, Italy, (13)GSK Vaccines, Wavre, Belgium, (14)GSK Vaccines, King of Prussia, PA

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

E. Athan, None

J. F. Barba-Gomez, GSK Vaccines: Grant Investigator , Research grant

W. Ghesquiere, None

S. J. Hwang, GSK Vaccines: Grant Investigator , Research grant

E. Leung, None

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

A. Poder, None

J. Puig-Barbera, None

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

A. Volpi, None

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

Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.