127. Efficacy, Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine in Adults Aged 60 Years and Older: Results from the ZOE-50 and ZOE-70 Efficacy Studies
Session: Oral Abstract Session: Newer and Older Vaccines in Older Adults
Thursday, October 27, 2016: 10:45 AM
Room: 388-390

Background: The recombinant herpes zoster (HZ) subunit vaccine candidate (HZ/su) had >90% efficacy (VE) against HZ in older adults in two phase 3 clinical trials (ZOE-50, ZOE-70 [NCT01165177, NCT01165229]). Here we report HZ/su VE against HZ and postherpetic neuralgia (PHN), immunogenicity and safety data in adults ≥60 years of age (YOA) from these studies (VE ≥60 YOA [ZOE-50], immunogenicity/safety 69–69 YOA [ZOE-50], immunogenicity/safety ≥70 YOA [pooled ZOE-50/70]).

Methods: Subjects were randomized 1:1 to receive 2 intramuscular doses of HZ/su vaccine (containing 50 µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) or placebo (saline solution) 2 months (M) apart. We report VE in reducing HZ and PHN compared to placebo, humoral immune responses (assessed by anti-gE ELISA prior to vaccination and 1, 12, 24 and 36M post-dose 2 [subset of subjects]) and safety (solicited [diary card subset of subjects] and unsolicited adverse events [AEs] collected for 7 and 30 days after each dose, respectively; medically attended AEs [MAEs] for 6M after dose 2; fatal events, serious AEs [SAEs] related to vaccination/study participation and potential immune-mediated diseases [pIMDs] until study end [all subjects]).

Results: 4490 subjects 60–69 YOA (HZ/su: 2244; control: 2246), 8122 ≥60 YOA (4053; 4069) (ZOE-50) and 17531 ≥70 YOA (8758; 8773) (pooled ZOE-50/70) were vaccinated. VE against HZ in ZOE-50 was 97.6% (95% confidence interval: 92.7–99.6) in adults ≥60 YOA. VE in 60–69 YOA was 97.4% (ZOE-50) and in ≥70 YOA, 91.3% (pooled ZOE-50/70). VE against PHN was 100.0% (55.2–100.0) in adults ≥60 YOA (ZOE-50) and 88.8% in ≥70 YOA (pooled ZOE-50/70) (Table 1). Highest vaccine response rates and geometric mean concentrations of anti-gE antibodies in the HZ/su group were observed 1M post-dose 2. Immune responses persisted for 36M post-vaccination (Figure 1). HZ/su vaccine was more reactogenic than placebo, but reactions were mostly mild or moderate and transient (Figure 2). SAEs, fatal cases and pIMDs were equally distributed between HZ/su group and placebo.

Conclusion: In adults ≥60 YOA, HZ/su vaccine is efficacious against HZ and PHN, highly immunogenic and has a clinically acceptable safety profile.

Funding: GlaxoSmithKline Biologicals SA


Janet E. Mcelhaney, MD1, Himal Lal, MD2, Anthony L. Cunningham, MB BS MD3, Myron Levin, MD, FIDSA4, Roman Chlibek, MD, PhD5, Javier Diez-Domingo, MD, PhD6, Eugene Athan, MBBS, FRACP, MPH7, Johan Berglund, MD8, H. Jackson Downey, MD9, Wayne Ghesquière, MD10, Olivier Godeaux, MD MPH2,11, Iris Gorfinkel, MD12, Shinn-Jang Hwang, MD13, Tiina Korhonen, MD14, Shelly Mcneil, MD, FRCPC, FIDSA15, Karlis Pauksens, MD, PhD16, Joan Puig-Barberà, MD6, Thiago J. Avelino-Silva, MD17, Timo Vesikari, MD, PhD18, Antonio Volpi, MD19, Daisuke Watanabe, MD, PhD20, Wilfred Yeo, MB ChB MD21, Laura Campora, MD22, Carline Vanden Abeele, MSc22, Lidia Oostvogels, MD22 and Thomas C. Heineman, MD, PhD2, (1)Health Sciences North Research Institute, Sudbury, ON, Canada, (2)GSK Vaccines, King of Prussia, PA, (3)Westmead Millennium Institute for Medical Research, Westmead, Australia, (4)Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, (5)University of Defence, Hradec Kralove, Czech Republic, (6)Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain, (7)Infectious Diseases, Barwon Health, Deakin University, Geelong, Australia, (8)Blekinge Institute of Technology and Blekinge Center for Competence, Karlskrona, Sweden, (9)Jacksonville Center for Clinical Research, Jacksonville, FL, (10)Section of Infectious Diseases, University of British Colombia, Victoria, BC, Canada, (11)Jansen Infectious Diseases and Vaccines, Leiden, Netherlands, (12)PrimeHealth Clinical Research Organization, Toronto, ON, Canada, (13)Taipei Veterans General Hospital; National Yang Ming University School of Medicine, Taipei, Taiwan, (14)University of Tampere, Tampere, Finland, (15)Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada, (16)Uppsala University Hospital, Uppsala, Sweden, (17)Division of Geriatrics, University of Sao Paulo Medical School, Sao Paulo, Brazil, (18)Vaccine Research Center, University of Tampere, Tampere, Finland, (19)Università di Roma Tor Vergata, Rome, Italy, (20)Aichi Medical University, Nagakute, Japan, (21)School of Medicine, University of Wollongong, Wollongong, Australia, (22)GSK Vaccines, Wavre, Belgium

Disclosures:

J. E. Mcelhaney, GSK group of companies: Scientific Advisor and Site PI for clinical trial , Institution received payments for enrollment in clinical trial and Speaker honorarium

H. Lal, GSK group of companies: Employee and Shareholder , Salary and stock

A. L. Cunningham, GSK group of companies: Board Member , My Institution received honorarium for an international advisory board meeting

M. Levin, GSK group of companies: Investigator and Scientific Advisor , Consulting fee and Grant recipient
Merck, Sharp & Dohme: Intellectual Property and Scientific Advisor , Consulting fee and patent royalty

R. Chlibek, GSK group of companies: Investigator , Research support

J. Diez-Domingo, SPMSD: Grant Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research grant and Speaker honorarium

E. Athan, None

J. Berglund, None

H. J. Downey, GSK group of companies, Pfizer, Protein Science: Investigator , Grant recipient

W. Ghesquière, None

O. Godeaux, GSK group of companies: Former Employee , Salary

I. Gorfinkel, GSK group of companies: Research Contractor , Research grant and Research support

S. J. Hwang, None

T. Korhonen, University of Tampere, Finland: Employee and Investigator , Salary

S. Mcneil, GSK group of companies: Grant Investigator , Collaborative Research Agreement , Grant recipient , Research grant and Research support
Pfizer: Grant Investigator , Collaborative Research Agreement , Grant recipient , Research grant and Research support

K. Pauksens, Akademiska sjukhuset, Uppsala University Hospital: Investigator , The institution received compensation to perform clinical trial

J. Puig-Barberà, None

T. J. Avelino-Silva, GSK group of companies: Investigator , Research support

T. Vesikari, University of Tampere: Investigator and Scientific Advisor , Research support

A. Volpi, SanofiPasteur MSD Italy: Scientific Advisor , Salary

D. Watanabe, GSK group of companies: Consultant , Consulting fee

W. Yeo, University of Wollongong: Employee and Investigator , Research support and Salary

L. Campora, GSK group of companies: Employee , Salary

C. Vanden Abeele, GSK group of companies: Employee , Salary

L. Oostvogels, GSK group of companies: Employee , Salary

T. C. Heineman, GSK group of companies: Employee and Shareholder , Salary

Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.