2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients
Session: Poster Abstract Session: Vaccines for Herpes Zoster Virus
Saturday, October 6, 2018
Room: S Poster Hall

Background: Herpes zoster (HZ) and its complications can have a substantial impact on patients’ quality of life (QoL), particularly in immunocompromised patients. The vaccine efficacy (VE) of an adjuvanted recombinant zoster vaccine (RZV) was studied in a randomized, placebo-controlled, phase 3 study in adult hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). The VE in preventing HZ cases was 68.2% (95% CI: 55.6%–77.5%). Herein we report the impact of the vaccine on patients’ quality of life (QoL) associated with HZ episodes.

Methods: HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1–2 months apart and followed for the occurrence of HZ. QoL parameters were measured by the Short-Form health survey (SF-36) and Euro-Quality of Life - 5 Dimension (EQ-5D) at baseline, 1 month and 1 year post-dose 2, as well as during suspected HZ episodes in conjunction with the Zoster Brief Pain Inventory (ZBPI). For confirmed HZ cases, QoL scores were compared between the vaccine and placebo groups. The RZV impact in reducing the ZBPI Burden of Illness and Burden of Interference scores was estimated in patients in the modified total vaccinated cohort (mTVC). The 2 scores were 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 patients who did not have a confirmed HZ episode.

Results: Both the ZBPI maximum Worst Pain and Average Pain scores were significantly lower in the vaccine than placebo group (Table 1), suggesting less burden in breakthrough HZ cases following RZV. Consequently, the HZ Burden of Illness and Burden of Interference VE estimates were higher than the HZ VE estimate. RZV showed statistically significantly better QoL scores than placebo one week following rash-onset among patients with confirmed HZ i.e. SF-36 bodily pain, social functioning, role emotional, mental health and mental component scores, and the EQ-5D Utility Score.

Conclusion: In addition to reducing the risk of HZ and HZ complications, RZV significantly reduces the impact of HZ on patient’s QoL in those who develop breakthrough disease.

Funding: GlaxoSmithKline Biologicals SA

Desmond Curran, PhD1, Achilles Anagnostopoulos, MD2, Ibrahim Barista, MD3, Adriana Bastidas, PhD1, Pranatharthi Chandrasekar, MD4, Michael Dickinson, MBBS FRACP FRCPA DMED SCI5, Inmaculada Heras, PhD6, Mohamed El Idrissi, MSc7, Sean Matthews, MSc8, Samuel Milliken, MBBS FRACP FRCPA9, Jorge Monserrat Coll, MD10, Maria Belen Navarro Matilla, MA, MBBS11, Lidia Oostvogels, MD12, Dimas Quiel, MD13, Scott Rowley, MD14, Waleed Sabry, MD MSc Doctorate in Hematology15, Dominik Selleslag, MD16, Jeff Szer, MB BS FRACP17, Koen Theunissen, MD18, Zeynep Arzu Yegin, Assoc. Prof.19, Su-Peng Yeh, MD20, Jo-Anne Young, MD21, Francesco Zaja, MD22 and Beata Piatkowska-Jakubas On Behalf Of The Zoe-Hsct Study Group, MD PhD Assoc Prof23, (1)GSK, Wavre, Belgium, (2)George Papanikolaou Hospital, Thessaloniki, Greece, (3)Hacettepe University Medical Faculty, Ankara, Turkey, (4)Infectious Diseases, Wayne State University, Detroit, MI, (5)Peter MacCallum Cancer Centre, Melbourne, Australia, (6)Hospital General Universitario J.M. Morales Meseguer, Murcia, Spain, (7)GSK, Rixensart, Belgium, (8)Freelance c/o GSK, Wavre, Belgium, (9)St Vincent’s Hospital, Sydney, Australia, (10)Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain, (11)Hospital Universitario Puerta de Hierro, Madrid, Spain, (12)CureVac AG, Tübingen, Germany, (13)Complejo Hospitalario Dr. Arnulfo Arias Madrid, Panama, Panama, (14)Hackensack University Medical Center, Hackensack, NJ, (15)Saskatoon Cancer Center, Saskatoon, SK, Canada, (16)A.Z. Sint-Jan, Brugge, Belgium, (17)Royal Melbourne Hospital, Melbourne, Australia, (18)Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, Belgium, (19)Gazi University School of Medicine, Ankara, Turkey, (20)China Medical University Hospital, Taichung, Taiwan, (21)University of Minnesota, Minneapolis, MN, (22)Azienda Ospedaliero Universitaria S. Maria Misericordia, Udine, Italy, (23)Jagiellonian University Medical College, Cracow, Poland

Disclosures:

D. Curran, GlaxoSmithKline: Employee , GSK Shares and Salary .

A. Anagnostopoulos, None

I. Barista, None

A. Bastidas, GSK: Employee , Salary .

P. Chandrasekar, None

M. Dickinson, None

I. Heras, None

M. El Idrissi, GSK: Employee and Shareholder , Salary .

S. Matthews, GSK group of companies: Consultant , Consulting fee .

S. Milliken, None

J. Monserrat Coll, None

M. B. Navarro Matilla, None

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

D. Quiel, None

S. Rowley, None

W. Sabry, None

D. Selleslag, None

J. Szer, None

K. Theunissen, None

Z. A. Yegin, None

S. P. Yeh, None

J. A. Young, GSK: Investigator , The University of Minnesota is reimbursed for contract costs associated with conducting clinical trials of vaccine. I receive no personal financial benefit. .

F. Zaja, None

B. Piatkowska-Jakubas On Behalf Of The Zoe-Hsct Study Group, None

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