Search

Your search keyword '"Chiara Sacripanti"' showing total 4 results
Start Over Author "Chiara Sacripanti"
4 results on '"Chiara Sacripanti"'

1. Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the 'ilmiovaccinoCOVID19 collaborating group'

Author

Nicoletta Luxi, Chiara Bellitto, Francesco Ciccimarra, Emiliano Cappello, Luca L’Abbate, Marco Bonaso, Chiara Ajolfi, Paolo Baldo, Roberto Bonaiuti, Claudio Costantino, Giovambattista De Sarro, Cristina Di Mauro, Giuseppina Fava, Marina Ferri, Alberto Firenze, Fabiana Furci, Luca Gallelli, Luca Leonardi, Giovanna Negri, Fabio Pieraccini, Elisabetta Poluzzi, Chiara Sacripanti, Elisa Sangiorgi, Ester Sapigni, Ilenia Senesi, Roberto Tessari, Luigia Trabace, Alfredo Vannacci, Francesca Venturini, Francesco Vitale, Donatella Zodda, Marco Tuccori, and Gianluca Trifirò

Subjects
active surveillance, vaccine safety, COVID-19, special cohorts, passive surveillance, Therapeutics. Pharmacology, RM1-950
Abstract

Introduction: In 2021, the European Medicines Agency supported the “Covid Vaccine Monitor (CVM),” an active surveillance project spanning 13 European countries aimed at monitoring the safety of COVID-19 vaccines in general and special populations (i.e., pregnant/breastfeeding women, children/adolescents, immunocompromised people, and people with a history of allergies or previous SARS-CoV-2 infection). Italy participated in this project as a large multidisciplinary network called the “ilmiovaccinoCOVID19 collaborating group.”Methods: The study aimed to describe the experience of the Italian network “ilmiovaccinoCOVID19 collaborating group” in the CVM context from June 2021 to February 2023. Comprising about 30 partners, the network aimed to facilitate vaccinee recruitment. Participants completed baseline and follow-up questionnaires within 48 h from vaccination over a 6-month period. Analyses focused on those who completed both the baseline and the first follow-up questionnaire (Q1), exploring temporal trends, vaccination campaign correlation, and loss to follow-up. Characteristics of recruited vaccinees and vaccinee-reported adverse drug reactions (ADRs) were compared with passive surveillance data in Italy.Results: From June 2021 to November 2022, 22,384,663 first doses and 38,207,452 booster doses of COVID-19 vaccines were administered in Italy. Simultaneously, the study enrolled 1,229 and 2,707 participants for the first and booster doses, respectively. Of these, 829 and 1,879 vaccinees, respectively, completed both baseline and at least Q1 and were included in the analyses, with a significant proportion of them (57.8%/34.3%) belonging to special cohorts. Most vaccinees included in the analyses were women. Comirnaty® (69%) and Spikevax® (29%) were the most frequently administered vaccines. ADR rates following Comirnaty® and Spikevax® were higher after the second dose, particularly following Spikevax®. Serious ADRs were infrequent. Differences were observed in ADR characteristics between CVM and Italian passive surveillance.Conclusion: This study confirmed the favorable safety profile of COVID-19 vaccines, with findings consistent with pivotal clinical trials of COVID-19 vaccines, although different proportions of serious ADRs compared to spontaneous reporting were observed. Continuous evaluation through cohort event monitoring studies provides real-time insights crucial for regulatory responses. Strengthening infrastructure and implementing early monitoring strategies are essential to enhance vaccine safety assessment and prepare for future pandemics.

Published
2024
Full Text
View/download PDF

2. Combined Central and Peripheral Demyelination with Anti-Neurofascin155 IgG Following COVID-19 Vaccination

Author

Eleonora Matteo, Michele Romoli, Calogero Calabrò, Laura Piccolo, Tiziana Lazzarotto, Manuela Suserea, Sara Contardi, Silvia Stagni, Liliana Gabrielli, Stefano Forlivesi, Mirna Bassi, Morena Borsari, Chiara Sacripanti, Elena Merli, Federica Naldi, Keivan M. Kaveh, Annamaria Borghi, Elisabetta Magni, Luigi Simonetti, Carlo Descovich, Elisa Vegezzi, Matteo Gastaldi, Andrea Zini, and Matteo E, Romoli M, Calabrò C, Piccolo L, Lazzarotto T, Suserea M, Contardi S, Stagni S, Gabrielli L, Forlivesi S, Bassi M, Borsari M, Sacripanti C, Merli E, Naldi F, Kaveh KM, Borghi A, Magni E, Simonetti L, Descovich C, Vegezzi E, Gastaldi M, Zini A.

Subjects
CNS inflammation, Letters to the Editor: New Observation, Peripheral neuropathy, Neurology, Neuroimmunology, COVID-19, Neurology (clinical), General Medicine, Demyelination, central and peripheral nervous system, COVID-19, vaccination
Abstract

No abstract available

Published
2021

3. Disproportionality signal of progressive multifocal leukoencephalopathy: monoclonal antibodies versus other immunosuppressants

Author

Carlo Piccinni, Elisabetta Poluzzi, Chiara Sacripanti, Fabrizio De Ponti, Carlo Piccinni, Chiara Sacripanti, Elisabetta Poluzzi, and Fabrizio De Ponti

Subjects
Pathology, medicine.medical_specialty, DISPROPORTIONALITY, Epidemiology, medicine.drug_class, business.industry, Progressive multifocal leukoencephalopathy, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY, Monoclonal antibody, medicine.disease, Virology, MONOCLONAL ANTIBODY, Antibodies monoclonal, medicine, FDA ADVERSE EVENT REPORTING SYSTEM, Pharmacology (medical), business, ADVERSE EVENT
Abstract

In 2010, our analysis of spontaneous and published reports of Progressive Multifocal Leukoencephalopathy (PML) coming from different sources (FDA Adverse Event Reporting System–AERS, WHO VigiBase and MEDLINE) suggested a possible strong relationship between PML and Monoclonal Antibodies (MAbs), especially when used in autoimmune diseases. Recently, Schmedt and colleagues, by using the public version of FDA AERS, have performed the first disproportionality analysis for the possible association between PML and immunosuppressive drugs, and found disproportionality signals for several immunosuppressants, especially MAbs (e.g. natalizumab, efalizumab and rituximab). This study prompted us to refine our analysis by applying a similar disproportionality method, in order to confirm or reject our previous speculation. Therefore, we performed a step-by-step disproportionality analysis for PML in the FDA AERS database by checking disproportionality for: (i) immunosuppressants vs. other drugs; (ii) among immunosuppressants, MAbs vs. Non-MAbs and (iii) each MAb, separately.

Published
2013

4. Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological immunomodulating agents

Author

Ugo Moretti, Elisabetta Poluzzi, Nicola Montanaro, Carlo Piccinni, Anita Conforti, Chiara Sacripanti, Domenico Motola, Lara Magro, Piccinni C, Sacripanti C, Poluzzi E, Motola D, Magro L, Moretti U, Conforti A, Montanaro N., Department of Pharmacology, Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), Clinical Pharmacology Unit, and University of Verona (UNIVR)

Subjects
Male, Antibodies, Neoplasm, medicine.medical_treatment, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY, Progressive multifocal leukoencephalopathy, Adverse drug reaction, Reporting system, Database, Monoclonal antibody, Leukoencephalopathy, Antibodies, Monoclonal, Murine-Derived, 0302 clinical medicine, MONOCLONAL ANTIBODY, Pharmacology (medical), 030212 general & internal medicine, Alemtuzumab, REPORTING SYSTEM, ComputingMilieux_MISCELLANEOUS, media_common, Slow virus, Leukoencephalopathy, Progressive Multifocal, Antibodies, Monoclonal, Immunosuppression, General Medicine, 3. Good health, Biological Therapy, Female, Rituximab, Immunosuppressive Agents, medicine.drug, Drug, Anti-HIV Agents, DATABASE, media_common.quotation_subject, Antibodies, Monoclonal, Humanized, Autoimmune Diseases, Immunomodulation, 03 medical and health sciences, Product Surveillance, Postmarketing, medicine, Adverse Drug Reaction Reporting Systems, Humans, Immunologic Factors, Retrospective Studies, Pharmacology, Biological Products, Transplantation, business.industry, ADVERSE DRUG REACTION, medicine.disease, Lymphoproliferative Disorders, Immunology, business, 030217 neurology & neurosurgery
Abstract

AIM: The aim of the present study was to collect and compare cases of drug-induced PML in order to contribute to the debate about the role of the underlying diseases and/or drug immunosuppression in PML occurrence. METHODS: We searched for drug-induced PML cases in two international spontaneous adverse drug reaction (ADR) report databases, FDA-AERS and WHO-VigiBase. From MEDLINE, we retrieved case reports and case series containing the MESH term "leukoencephalopathy, progressive multifocal/chemically induced". In order to assess the PML-drug relationship, we analysed drug-reaction pairs in terms of the patients' underlying diseases and co-suspected drugs. RESULTS: Overall, 214 cases in FDA-AERS, 118 in WHO-VigiBase and 140 in MEDLINE were collected. Therapeutic groups more frequently involved in PML cases were monoclonal antibodies (MAbs), conventional immunosuppressive drugs and anti-HIV drugs. The most frequent underlying diseases were lymphoproliferative diseases (28%), autoimmune disorders (20%) and transplants (10%). MAbs were more often reported in cases where they were the only suspected drugs, whereas for the other therapeutic groups, concomitant drugs were reported. CONCLUSIONS: We found a strong relationship between PML and MAbs, especially when used in autoimmune diseases. PML is becoming a crucial issue of MAbs, since they can cause severe ADRs through the imbalance of the immune system. Based on these results, patients treated with MAbs should be carefully monitored for early signs and symptoms of PML.

Published
2010

Catalog

Books, media, physical & digital resources
See catalog results