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Marta López-Fauqued Laura Campora Frédérique Delannois Mohamed El Idrissi Lidia Oostvogels Ferdinandus J. De Looze Javier Diez-Domingo Thomas C. Heineman Himal Lal Janet E. McElhaney Shelly A. McNeil Wilfred Yeo Fernanda Tavares-Da-Silva 《Vaccine》2019,37(18):2482-2493
Background
The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.Methods
Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30?days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12?months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.Results
Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.Conclusions
No safety concerns arose, supporting the favorable benefit-risk profile of RZV. 相似文献2.
C Eder P Proksch V Wray R W van Soest E Ferdinandus L A Pattisina S Sudarsono 《Journal of natural products》1999,62(9):1295-1297
Two new dimeric bromopyrrole alkaloids, nakamuric acid (1) and its corresponding methyl ester (2), have been isolated from the Indopacific sponge Agelas nakamurai along with the known metabolites sceptrin (3), debromosceptrin (4), and ageliferin (5). Their structures were identified by analysis of spectral data. All compounds inhibited the growth of several Gram-positive and Gram-negative bacteria in the agar plate diffusion assay. 相似文献
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The developmental pattern of in vitro intracellular accumulation (IA) was studied in the small intestine of the offspring of females fed a 27% protein diet (normal) (NPD animals) and the offspring of females fed an 8% protein diet (low) (LPD animals). At 2 days of age, the IA of L-leucine (Leu) and D-galactose (Gal) was significantly reduced in the intestines of the LPD animals as compared to the NPD animals at initial velocities (75% and 81%) and under steady state conditions (82% and 84%). The IA of both compounds in the intestines of the LPD animals increased relative to the NPD animals until at weaning the IA of Leu and Gal under steady state conditions was significantly greater in the LPD animals (139% and 133%). After weaning, the IA of Leu was statistically increased (137%) and the IA of Gal was the same in the LPD animals as compared to the NPD animals at initial velocities. The variations in the developmental patterns of the IA of Leu and Gal in the intestines of LPD animals as compared to NPD animals appear to be related to animal age, which may reflect an improved caloric intake at weaning. 相似文献
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Ferdinandus Justin Violet John Sandhu Shahneen Hicks Rodney J. Ravi Kumar Aravind S. Iravani Amir Kong Grace Akhurst Tim Thang Sue Ping Murphy Declan G. Williams Scott Hofman Michael S. 《European journal of nuclear medicine and molecular imaging》2020,47(10):2322-2327
European Journal of Nuclear Medicine and Molecular Imaging - We analysed quantitative biomarkers derived from both baseline whole-body imaging and blood serum to identify prognostic markers in... 相似文献
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Ferdinandus J. Oertel M. Eichenauer D. A. Meissner J. Engert A. Borchmann P. 《Der Onkologe》2022,28(10):889-900
Die Onkologie - Sowohl gemäß der Positronenemissionstomographie (PET-)adaptierte Protokolle als auch neue Substanzen haben in den letzten Jahren Einzug in die Erstlinientherapie des... 相似文献
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Kryss T. McKenna Leigh R. Tooth David B. King Michele J. Clark Peter K. O'Rourke Margaret A. Steinberg Ferdinandus J. de Looze 《Australasian journal on ageing》2003,22(1):15-19
Objectives: To determine GPs' reported use of written education materials with older patients and older patients' reported receipt of these materials. To determine GPs' and older patients' perceptions of written materials. Method: Using self‐report questionnaires, two populations were surveyed; a randomised sample of SO GPs (29 males and 21 females) practising in Brisbane's southern suburbs and a convenience sample of 188 older community‐dwelling people (aged over 64 years). Results: All GPs reported using written materials with patients, although 28% had not given any to the last 10 patients. This increased to 46% when patients were older. Twenty percent of patients wanted more written information from their GP, while some GPs believed that older patients preferred verbal information and gave out written information only when they perceived patient interest. All GPs reported giving written materials at the time of consultation and over two‐thirds discussed the content with patients. Just over 50% of patients reported receiving written information from GPs in the last six months and only half of these again discussed it directly with their GP. Overall, patients were more positive than GPs about the value of written education materials. Conclusions: Older patients' desire for written information may be better met if they are more assertive in requesting this of GPs and GPs may better serve their patients' needs if they make written information more readily available to them. Better access to materials and more financial incentives to give them out might also increase GPs' use of written materials. 相似文献