Quality-of-Life Impact of an Investigational Subunit-Adjuvanted Herpes Zoster Vaccine in Adults ≥50 Years of Age
Bibliographic record
Abstract
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 below. Table 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. Disclosures. D. Curran, GSK group of companies: Employee, Salary and stock equity; J. Diez-Domingo, Sanofi Pasteur MSD: Board Member and Grant Investigator, Consulting fee and Research grant. GSK group of companies: Board Member, Consulting fee; T. C. Heineman, GSK group of companies: Employee, Salary and stock equity; H. Lal, Pfizer: Employee, Salary GSK group of companies: former employee, Salary; M. J. 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
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".