912. Quality of Life impact of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine in adults≥50 years of age
Session: Oral Abstract Session: Vaccines, Vaccine Preventable Disease, and their Impact
Friday, October 28, 2016: 8:45 AM
Room: 275-277
Background:

Herpes zoster (HZ) and its complications can have a substantial impact on patients’ quality of life (QL). The ZOE 50 (NCT01165177) and ZOE 70 (NCT01165229) randomized, placebo-controlled phase-3 studies investigated the efficacy of a subunit vaccine (HZ/su), containing recombinant varicella-zoster virus glycoprotein E and the AS01B Adjuvant System, in adults aged ≥50 and ≥70 years, respectively. Here we report the impact of HZ/su on QL parameters associated with HZ episodes.

Methods:

Subjects received 2 doses of HZ/su or placebo intramuscularly 2 months apart. QL parameters were measured by standard instruments: The Short-Form health survey (SF-36) and Euro-Quality of Life - 5 Dimension (EQ-5D) were assessed at baseline, at months 14, 26 and 38, and also during suspected HZ episodes in conjunction with the Zoster Brief Pain Inventory (ZBPI). In confirmed HZ cases, QL scores were compared between the 2 groups. The vaccine efficacy in reducing the ZBPI Burden of Illness and ZBPI Burden of Interference scores were estimated in all subjects in the modified total vaccinated cohort (mTVC). The latter 2 scores are calculated from the area under the curve (Days 0 to 182) of the ZBPI Worst pain and ZBPI Activities of Daily Living scores, respectively, assuming a score of 0 for subjects who do not have a confirmed HZ episode. These results focus on the ZOE 50 study population and the ZOE 50 and 70 pre-specified combined study populations, which include subjects, aged ≥70 years (ZOE 70+).

Results:

The results from the analysis of the ZBPI questionnaire are presented in the table 1 below.

Table 1

ZOE 50

ZOE 70+

Statistic

HZ/su

Placebo

HZ/su

Placebo

mTVC Subjects

7304

7413

8250

8343

HZ Confirmed Cases

9

254

25

284

Maximum Worst Pain: Mean

5.5

6.7

5.7

7.0

Wilcoxon Test

P=0.1133

P=0.0316

Maximum Average Pain: Mean

3.9

5.5

4.5

5.6

Wilcoxon Test

P=0.0486

P=0.0431

 

Burden of Illness Efficacy

98.4%

92.1%

Burden of Interference Efficacy

99.1%

90.3%

HZ/su: Herpes zoster subunit vaccine; mTVC: modified total vaccinated cohort

 

Results from the SF-36 and EQ-5D questionnaires involving repeated measurements over time will also be presented.

Conclusion:

In addition to significantly reducing the risk of HZ, the vaccine also reduces the severity of HZ in those who develop breakthrough disease.

Desmond Curran, PhD1, Eugene Athan, MBBS, FRACP, MPH2, Javier Diez-Domingo, MD, PhD3, Wayne Ghesquiere, MD FRCPC4, Thomas C. Heineman, MD, PhD5, Himal Lal, MD6, Edward Leung, MD7, Myron Levin, MD, FIDSA8, Sean Matthews, MSc9, Janet E. Mcelhaney, MD10, Shelly a Mcneil, MD, FRCPC, FIDSA11, Lidia Oostvogels, MD9, Karlis Pauksens, MD, PhD12, Joan Puig-Barbérà, MD MPH PhD13, Antonio Volpi, MD14, Daisuke Watanabe, MD, PhD15, Wilfred Yeo, MB ChB MD16 and Robert W Johnson, MD17, (1)Health Economics, GSK Vaccines, Wavre, Belgium, (2)Infectious Diseases, Barwon Health, Deakin University, Geelong, Australia, (3)Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain, (4)Royal Jubilee Hospital and Victoria General Hospital, Victoria, BC, Canada, (5)GSK Vaccines, King of Prussia, PA, (6)Pfizer, Collegeville, PA, (7)Department of Medicine, United Christian Hospital, Kowloon, Hong Kong, (8)Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, (9)GSK Vaccines, Wavre, Belgium, (10)Health Sciences North Research Institute of Canada, Sudbury, ON, Canada, (11)Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada, (12)Uppsala University Hospital, Uppsala, Sweden, (13)Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain, (14)Università di Roma Tor Vergata, Rome, Italy, (15)Aichi Medical University, Nagakute, Japan, (16)School of Medicine, University of Wollongong, Wollongong, Australia, (17)University of Bristol, Bristol, United Kingdom

Disclosures:

D. Curran, GSK group of companies: Employee , Salary and stock equity

E. Athan, None

J. Diez-Domingo, Sanofi Pasteur MSD: Board Member and Grant Investigator , Consulting fee and Research grant
GSK group of companies: Board Member , Consulting fee

W. Ghesquiere, None

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

H. Lal, Pfizer: Employee , Salary
GSK group of companies: former employee , Salary

E. Leung, None

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

S. Matthews, GSK Vaccines: freelance , Consulting fee

J. E. Mcelhaney, GSK group of companies: Dr. McElhaney’s institution , compensation for travel and meeting attendance
Pfizer: Dr. McElhaney’s institution , compensation for travel and meeting attendance
Merck: Dr. McElhaney’s institution , compensation for travel and meeting attendance
Sanofi Pasteur: Dr. McElhaney’s institution , compensation for travel and meeting attendance

S. A. Mcneil, GSK: Grant Investigator , Research grant and Research support
Pfizer: Grant Investigator , Consulting fee , Research grant , Research support and Speaker honorarium
Merck: Consultant and Investigator , Consulting fee , Research support and Speaker honorarium

L. Oostvogels, GSK group of companies: Employee , Salary and stock equity

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

J. Puig-Barbérà, GSK group of companies: Grant Investigator , personal fees and Research grant
Novartis Vaccines: Grant Investigator , personal fees and Research grant

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

D. Watanabe, GSK group of companies: Grant Investigator and personal fees , Grant recipient
Maaruho: Grant Investigator and personal fees , consulting and lectures
Mochida: personal fees , lectures
Japan Vaccines: personal fees , consulting

W. Yeo, GSK group of companies: payments , payments

R. W. Johnson, GSK group of companies: Board Member and personal fees , Consulting fee and personal fees
SanofiPasteur MSD: Board Member and personal fees , lectures to medical societies
Merck Inc: Board Member and personal fees , educational video production

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.