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- Boutry, Céline, et al.
(author)
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The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster : Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70
- 2022
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In: Clinical Infectious Diseases. - : Oxford University Press. - 1058-4838 .- 1537-6591. ; 74:8, s. 1459-1467
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Journal article (peer-reviewed)abstract
- Efficacy against herpes zoster and immune responses to the adjuvanted recombinant zoster vaccine plateaued at high levels between 5.1 and 7.1 years (mean) post-vaccination, suggesting that its clinical benefit in older adults is sustained for at least 7 years post-vaccination. Background This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age >= 50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after >= 2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. Methods Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing >= 2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. Results Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. Conclusions Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination.
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| 2. |
- Munoz Fernandez, Shirley Steffany, et al.
(author)
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Applicability of the GLIM criteria for the diagnosis of malnutrition in older adults in the emergency ward : A pilot validation study
- 2021
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In: Clinical Nutrition. - : Elsevier. - 0261-5614 .- 1532-1983. ; 40:11, s. 5447-5456
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Journal article (peer-reviewed)abstract
- Background & aims: Acutely ill older adults are at higher risk of malnutrition. This study aimed to explore the applicability and accuracy of the GLIM criteria to diagnose malnutrition in acutely ill older adults in the emergency ward (EW).Methods: We performed a retrospective secondary analysis, of an ongoing cohort study, in 165 participants over 65 years of age admitted to the EW of a Brazilian university hospital. Nutrition assessment included anthropometry, the Simplified Nutritional Assessment Questionnaire (SNAQ), the Malnutrition Screening Tool (MST), and the Mini-Nutritional Assessment (MNA). We diagnosed malnutrition using GLIM criteria, defined by the parallel presence of at least one phenotypic [nonvolitional weight loss (WL), low BMI, low muscle mass (MM)] and one etiologic criterion [reduced food intake or assimilation (RFI), disease burden/inflammation]. We used the receiver operating characteristic (ROC) curves and Cox and logistic regression for data analyses.Results: GLIM criteria, following the MNA-SF screening, classified 50.3% of participants as malnourished, 29.1% of them in a severe stage. Validation of the diagnosis using MNA-FF as a reference showed good accuracy (AUC = 0.84), and moderate sensitivity (76%) and specificity (75.1%). All phenotypic criteria combined with RFI showed the best metrics. Malnutrition showed a trend for an increased risk of transference to intensive care unit (OR = 2.08, 95% CI 0.99, 4.35), and severe malnutrition for in-hospital mortality (HR = 4.23, 95% CI 1.2, 14.9).Conclusion: GLIM criteria, following MNA-SF screening, appear to be a feasible approach to diagnose malnutrition in acutely ill older adults in the EW. Nonvolitional WL combined with RFI or acute inflammation were the best components identified and are easily accessible, allowing their potential use in clinical practice.
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