المؤلفون: Oostvogels, Lidia, Heineman, Thomas C., Johnson, Robert W., Levin, Myron J., McElhaney, Janet E., Van den Steen, Peter, Zahaf, Toufik, Dagnew, Alemnew F., Chlibek, Roman, Diez-Domingo, Javier, Gorfinkel, Iris S., Herve, Caroline, Hwang, Shinn-Jang, Ikematsu, Hideyuki, Kalema, George, Lal, Himal, McNeil, Shelly A., Mrkvan, Tomas, Pauksens, Karlis, Smetana, Jan, Watanabe, Daisuke, Weckx, Lily Yin, Cunningham, Anthony L., Ahonen, Anitta, Athan, Eugene, Berglund, Johan, Choi, Won Suk, de Looze, Ferdinandus J., Desole, Maria Giuseppina, Esen, Meral, Geeraerts, Brecht, Ghesquiere, Wayne, Rombo, Lars, Volpi, Antonio

المصدر: Human Vaccines & Immunotherapeutics. 15(12):2865-2872

مصطلحات موضوعية: Varicella-zoster virus, adjuvanted recombinant zoster vaccine, vaccine efficacy, vaccine safety, underlying chronic disease, comorbidity

الوصف: In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ). Adults aged >= 50 or >= 70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment. At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported >= 1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant. As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.

وصف الملف: electronic

الوصول الحر: https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-409460Test
https://doi.org/10.1080/21645515.2019.1627818Test
https://uu.diva-portal.org/smash/get/diva2:1425701/FULLTEXT01.pdfTest

المؤلفون: Lopez-Fauqued, Marta, Campora, Laura, Delannois, Frederique, El Idrissi, Mohamed, Oostvogels, Lidia, De Looze, Ferdinandus J., Diez-Domingo, Javier, Heineman, Thomas C., Lal, Himal, McElhaney, Janet E., McNeil, Shelly A., Yeo, Wilfred, Tavares-Da-Silva, Fernanda, Ahonen, Anitta, Avelino-Silva, Thiago Junquera, Fernando Barba-Gomez, Jose, Berglund, Johan, Brotons Cuixart, Carlos, Caso, Covadonga, Chlibek, Roman, Choi, Won Suk, Cunningham, Anthony L., Desole, Maria Guiseppina, Eizenberg, Peter, Esen, Meral, Espie, Emmanuelle, Gervais, Pierre, Ghesquiere, Wayne, Godeaux, Olivier, Gorfinkel, Iris, Hui, David Shu Cheong, Hwang, Shinn-Jang, Korhonen, Tiina, Kovac, Martina, Ledent, Edouard, Leung, Edward, Levin, Myron J., Narejos Perez, Silvia, Neto, Jose Luiz, Pauksen, Karlis, Poder, Airi, Rodriguez de la Pinta, Maria Luisa, Rombo, Lars, Schwarz, Tino F., Smetana, Jan, Staniscia, Tommaso, Tinoco, Juan Carlos, Toma, Azhar, Vastiau, Ilse, Vesikari, Timo, Volpi, Antonio, Watanabe, Daisuke, Weckx, Lily Yin, Zahaf, Toufik

المصدر: Vaccine. 37(18):2482-2493

مصطلحات موضوعية: Varicella-zoster virus, Vaccine, Safety, Reactogenicity

الوصف: 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.

وصف الملف: electronic

الوصول الحر: https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-387212Test
https://doi.org/10.1016/j.vaccine.2019.03.043Test
https://uu.diva-portal.org/smash/get/diva2:1330190/FULLTEXT01.pdfTest

المؤلفون: Volpi, Antonio

الوصول الحر: https://www.europeana.eu/item/9200369/webclient_DeliveryManager_pid_13878962_custom_att_2_simple_viewer?utm_source=api&utm_medium=api&utm_campaign=YuvuWBeCaTest

المؤلفون: Volpi, Antonio I

الوصول الحر: http://europeana.eu/portal/record/9200332/BibliographicResource_3000095372629.htmlTest

المؤلفون: Benvenuto, Monica, Mattera, Rosanna, Sticca, Joshua Ismaele, Rossi, Piero, Cipriani, Chiara, Giganti, Maria Gabriella, Volpi, Antonio, Modesti, Andrea, Masuelli, Laura, Bei, Roberto

المساهمون: Benvenuto, Monica, Mattera, Rosanna, Sticca, Joshua Ismaele, Rossi, Piero, Cipriani, Chiara, Giganti, Maria Gabriella, Volpi, Antonio, Modesti, Andrea, Masuelli, Laura, Bei, Roberto

مصطلحات موضوعية: AT-101, BH3 mimetic, apoptosi, autophagy, malignant mesothelioma, polyphenol

الوصف: Malignant mesothelioma (MM) is a primary tumor arising from mesothelial cells. The survival of MM patients following traditional chemotherapy is poor, thus innovative treatments for MM are needed. (-)-gossypol (AT-101) is a BH3 mimetic compound which possesses anti-tumoral activity by targeting multiple signaling transduction pathways. Several clinical trials employing AT-101 have been performed and some of them are still ongoing. Accordingly, we investigated the in vitro effects of AT-101 on cell proliferation, cell cycle regulation, pro-survival signaling pathways, apoptosis and autophagy of human (MM-B1, H-Meso-1, and MM-F1) and mouse (#40a) MM cell lines. In addition, we explored the in vivo anti-tumor activities of AT-101 in a mouse model, in which the transplantation of MM cells induces ascites in the peritoneal space. AT-101 inhibited in vitro MM cells survival in a dose- and time-dependent manner and triggered autophagy, but the process was then blocked and was coincident with apoptosis activation. To confirm the effect of AT-101 in inducing the apoptosis of MM cells, MM cells were simultaneously treated with AT-101 and with the caspase inhibitor, Z-VAD-FMK. Z-VAD-FMK was able to significantly reduce the number of cells in the subG1 phase compared to the treatment with AT-101 alone. This result corroborates the induction of cell death by apoptosis following treatment with AT-101. Indeed, Western blotting results showed that AT-101 increases Bax/Bcl-2 ratio, modulates p53 expression, activates caspase 9 and the cleavage of PARP-1. In addition, the treatment with AT-101 was able to: (a) decrease the ErbB2 protein expression; (b) increase the EGFR protein expression; (c) affect the phosphorylation of ERK1/2, p38 and AKT; (d) stimulate JNK1/2 and c-jun phosphorylation. Our in vivo results showed that the intraperitoneal administration of AT-101 increased the median survival of C57BL/6 mice intraperitoneally transplanted with #40a cells and reduced the risk of developing tumors. Our findings may have ...

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/30459622; info:eu-repo/semantics/altIdentifier/wos/WOS:000449323300001; volume:9; firstpage:1; lastpage:13; numberofpages:13; journal:FRONTIERS IN PHARMACOLOGY; http://hdl.handle.net/11573/1274815Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85056289641

الإتاحة: https://doi.org/10.3389/fphar.2018.01269Test
http://hdl.handle.net/11573/1274815Test

المؤلفون: Zorzoli, Ermanno, Pica, Francesca, Masetti, Giulia, Franco, Elisabetta, Volpi, Antonio, Gabutti, Giovanni

المساهمون: Zorzoli, Ermanno, Pica, Francesca, Masetti, Giulia, Franco, Elisabetta, Volpi, Antonio, Gabutti, Giovanni

مصطلحات موضوعية: Elderly, Epidemiology, Frailty, Herpes zoster, Prevention, Treatment

الوصف: Population aging is a worldwide phenomenon with significant and manifold impacts on society. Advanced age correlates with the onset of frailty. In this vulnerable state, the immune response is weakened and a higher susceptibility to infectious diseases is observed. The present narrative review aims to cover the topic of herpes zoster (HZ) and its complications in frail populations. The lifetime risk of developing HZ is estimated at about 20-30%, and the risk increases with age. In older people, HZ can lead to the inability to recover the lifestyle, the interests, and the level of activity that existed before its development. Severity of the disease at presentation and depression are the major correlates of pain burden in patients with acute HZ and postherpetic neuralgia (PHN). The frail elderly need careful assessment prior to treatment initiation and could be affected to a greater extent by treatment-related adverse events. In light of the significant burden caused by HZ and its complications in the frail elderly, the adoption of a preventive strategy appears to be promising, particularly using vaccination in appropriate age- and risk-groups. Although very few vaccine studies consider explicitly the frail elderly as their study population, there is evidence that the live, attenuated vaccine induces significant immunological responses. An adjuvanted recombinant subunit vaccine has recently been approved in Canada, in the United States, in the European Union, and in Japan, and will likely provide additional opportunities for prevention.

وصف الملف: ELETTRONICO

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/29721782; info:eu-repo/semantics/altIdentifier/wos/WOS:000435713200001; volume:30; issue:7; firstpage:693; lastpage:702; numberofpages:10; journal:AGING CLINICAL AND EXPERIMENTAL RESEARCH; http://hdl.handle.net/11392/2391613Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85048823925; https://link.springer.com/article/10.1007/s40520-018-0956-3Test

الإتاحة: https://doi.org/10.1007/s40520-018-0956-3Test
http://hdl.handle.net/11392/2391613Test

المؤلفون: López Fauqued, Marta, Campora, Laura, Delannois, Frédérique, El Idrissi, Mohamed, Oostvogels, Lidia, De Looze, Ferdinandus, Diez-Domingo, Javier, Heineman, Thomas, Lal, Himal, McElhaney, Janet, McNeil, Shelly, Yeo, Wilfred, Tavares-Da-Silva, Fernanda, Ahonen, Anitta, Avelino-Silva, Thiago, Barba-Gomez, José Fernando, Berglund, Johan, Brotons, Carlos, Caso, Covadonga, Chlibek, Roman, Choi, Won Suk, Cunningham, Anthony, Desole, Maria Giuseppina, Eizenberg, Peter, Esen, Meral, Espié, Emmanuelle, Gervais, Pierre, Ghesquiere, Wayne, Godeaux, Olivier O., Gorfinkel, Iris, Hui, David Shu Cheong, Hwang, Shinnjang, Korhonen, Tiina, Kovac, Martina, Ledent, Edouard Y., Leung, Edward Man Fuk, Levin, Myron, Perez, Silvia Narejos, de Andrade Neto, José Luiz, Pauksens, Karlis, Poder, Airi, Rodriguez de la Pinta, Maria Luisa, Rombo, Lars, Schwarz, Tino Francis, Smetana, Jan, Staniscia, Tommaso, Tinoco-Fávila, Juan Carlos, Toma, Azhar, Vastiau, Ilse, Vesikari, Timo H., Volpi, Antonio, Watanabe, Daisuke, Weckx, Lily, Zahaf, Toufik, Universitat Autònoma de Barcelona

مصطلحات موضوعية: Reactogenicity, Safety, Vaccine, Varicella-zoster virus

الوصف: 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. 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. 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. No safety concerns arose, supporting the favorable benefit-risk profile of RZV.

وصف الملف: application/pdf

العلاقة: Vaccine; Vol. 37 Núm. 18 (24 2019), p. 2482-2493; https://ddd.uab.cat/record/285849Test; urn:10.1016/j.vaccine.2019.03.043; urn:oai:ddd.uab.cat:285849; urn:scopus_id:85063476515; urn:articleid:18732518v37n18p2482; urn:pmid:30935742

الإتاحة: https://ddd.uab.cat/record/285849Test

المؤلفون: Volpi, Antonio, Boccalini, Sara, Dari, Silvia, Clarke, Christopher, Curran, Desmond, Loiacono, Idalba, Pitrelli, Andrea, Puggina, Anna, Tosatto, Roberta, Van Oorschot, Desirée, Franco, Elisabetta

المصدر: Human Vaccines & Immunotherapeutics ; volume 16, issue 2, page 327-334 ; ISSN 2164-5515 2164-554X

الإتاحة: https://doi.org/10.1080/21645515.2019.1657753Test

المؤلفون: Curra, Desmond, Oostvogel, Lidia, Heineman, Thomas, Matthews, Sean, McElhaney, Janet, McNeil, Shelly, Díez Domingo, Javier, Lal, Himal, Andrews, Charles, Athan, Eugene, Berglund, Johan, Campora, Laura, de Looze, Ferdinandus, Korhonen, Tiina, Leung, Edward, Levin, Myron, Volpi, Antonio, Johnson, Robert W.

مصطلحات موضوعية: Burden of illness, Burden of interference, Activities of daily living, 6310.11 Bienestar Social, 6310.09 Calidad de Vida, 2412.10 Vacunas

الوصف: 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. ; GlaxoSmithKline Biologicals SA was the funding source and was involved in all study (NCT01165177 and NCT01165229) activities and overall data management (collection, analysis, and interpretation). GlaxoSmithKline Biologicals SA also funded all costs associated with the development and the ...

العلاقة: http://hdl.handle.net/20.500.12466/3275Test; http://hdl.handle.net/20.500.12466/3271Test

الإتاحة: https://doi.org/20.500.12466/3271Test
https://doi.org/10.1093/gerona/gly150Test
https://hdl.handle.net/20.500.12466/3271Test

المؤلفون: Kovac, Martina, Lal, Himal, Cunningham, Anthony L., Levin, Myron J., Johnson, Robert W., Campora, Laura, Volpi, Antonio, Heineman, Thomas C.

المصدر: Kovac , M , Lal , H , Cunningham , A L , Levin , M J , Johnson , R W , Campora , L , Volpi , A , Heineman , T C 2018 , ' Complications of herpes zoster in immunocompetent older adults : Incidence in vaccine and placebo groups in two large phase 3 trials ' , Vaccine , vol. 36 , no. 12 , pp. 1537-1541 . https://doi.org/10.1016/j.vaccine.2018.02.029Test

مصطلحات موضوعية: Complications, Herpes zoster, Hospitalisation, Postherpetic neuralgia, Vaccine efficacy, Varicella-zoster virus

الوصف: Background: An adjuvanted herpes zoster (HZ) subunit vaccine, HZ/su, demonstrated high efficacy against HZ and postherpetic neuralgia (PHN) in two randomized, observer-blind, placebo-controlled trials in adults aged ≥50 and ≥70 years (ZOE-50 and ZOE-70, respectively). Methods: Data from ZOE-50 and ZOE-70 trials were analyzed to evaluate the efficacy of HZ/su against mortality, hospitalizations, and non-PHN complications of HZ including HZ-associated vasculitis, stroke, and disseminated, ophthalmic, neurologic, and visceral diseases. Results: In the pooled ZOE-50/ZOE-70 analysis, 1 of 32 HZ/su recipients (3.1%) and 16 of 477 placebo recipients (3.4%) with a confirmed HZ episode had complications other than PHN. Efficacy against HZ-related complications was 93.7% (95% confidence interval, 59.5–99.9%) in adults aged ≥50 years and 91.6% (43.3–99.8%) in adults ≥70 years. Five HZ-related hospitalizations, all in placebo recipients, and no HZ-related deaths were reported. Conclusions: HZ/su reduces the risk of HZ-associated complications in older adults (NCT01165177; NCT01165229).

وصف الملف: application/pdf

الإتاحة: https://doi.org/10.1016/j.vaccine.2018.02.029Test
https://hdl.handle.net/1983/ad82284d-658e-4472-b7bf-4086b87fa92dTest
https://research-information.bris.ac.uk/en/publications/ad82284d-658e-4472-b7bf-4086b87fa92dTest
https://research-information.bris.ac.uk/ws/files/159337621/1_s2.0_S0264410X18302032_main.pdfTest
http://www.scopus.com/inward/record.url?scp=85042100030&partnerID=8YFLogxKTest