Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older
Por:
Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW and ZOE-50/70 study group
Publicada:
1 ago 2019
Ahead of Print:
27 jun 2018
Resumen:
Background: To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life.
Methods: The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined.
Results: The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset.
Conclusions: Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss.
Filiaciones:
Curran D:
GSK, Wavre, Belgium
Oostvogels L:
GSK, Wavre, Belgium
Heineman T:
GSK, King of Prussia, Pennsylvania, USA
Current affiliation: Genocea Biosciences, Cambridge, Massachusetts, USA
Matthews S:
Freelance, GSK, Wavre, Belgium
McElhaney J:
Health Sciences North Research Institute, Sudbury, Ontario, Canada
McNeil S:
Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada
:
FISABIO-Public Health, Valencia, Spain
Lal H:
GSK, King of Prussia, Pennsylvania, USA
Current affiliation: Pfizer Vaccine Inc, Collegeville, Philadelphia, Pennsylvania, USA
Andrews C:
Diagnostics Research Group, San Antonio, Texas, USA
Athan E:
Department of Infectious Disease, Barwon Health, Deakin University, Geelong, Victoria, Australia
Berglund J:
Department of Medical Radiation Physics, Karolinska University Hospital, Stockholm, Sweden
Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden
Campora L:
GSK, Wavre, Belgium
de Looze F:
AusTrials Pty Ltd, Sherwood, QLD, Australia and School of Medicine, University of Queensland, Brisbane, QLD, Australia
Korhonen T:
Tampere Vaccine Research Clinic, Tampere, Finland
Leung E:
United Christian Hospital, Hong Kong
Levin M:
Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
Volpi A:
University of Rome Tor Vergata, Rome, Italy
Johnson RW:
University of Bristol, Bristol, United Kingdom
hybrid, Green Published
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