Cargando…

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects

Background: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. Methods: A multi-country, three-phase...

Descripción completa

Detalles Bibliográficos
Autores principales: Riad, Abanoub, Schünemann, Holger, Attia, Sameh, Peričić, Tina Poklepović, Žuljević, Marija Franka, Jürisson, Mikk, Kalda, Ruth, Lang, Katrin, Morankar, Sudhakar, Yesuf, Elias Ali, Mekhemar, Mohamed, Danso-Appiah, Anthony, Sofi-Mahmudi, Ahmad, Pérez-Gaxiola, Giordano, Dziedzic, Arkadiusz, Apóstolo, João, Cardoso, Daniela, Marc, Janja, Moreno-Casbas, Mayte, Wiysonge, Charles Shey, Qaseem, Amir, Gryschek, Anna, Tadić, Ivana, Hussain, Salman, Khan, Mohammed Ahmed, Klugarova, Jitka, Pokorna, Andrea, Koščík, Michal, Klugar, Miloslav
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8345554/
https://www.ncbi.nlm.nih.gov/pubmed/34360156
http://dx.doi.org/10.3390/ijerph18157859
_version_ 1783734656716242944
author Riad, Abanoub
Schünemann, Holger
Attia, Sameh
Peričić, Tina Poklepović
Žuljević, Marija Franka
Jürisson, Mikk
Kalda, Ruth
Lang, Katrin
Morankar, Sudhakar
Yesuf, Elias Ali
Mekhemar, Mohamed
Danso-Appiah, Anthony
Sofi-Mahmudi, Ahmad
Pérez-Gaxiola, Giordano
Dziedzic, Arkadiusz
Apóstolo, João
Cardoso, Daniela
Marc, Janja
Moreno-Casbas, Mayte
Wiysonge, Charles Shey
Qaseem, Amir
Gryschek, Anna
Tadić, Ivana
Hussain, Salman
Khan, Mohammed Ahmed
Klugarova, Jitka
Pokorna, Andrea
Koščík, Michal
Klugar, Miloslav
author_facet Riad, Abanoub
Schünemann, Holger
Attia, Sameh
Peričić, Tina Poklepović
Žuljević, Marija Franka
Jürisson, Mikk
Kalda, Ruth
Lang, Katrin
Morankar, Sudhakar
Yesuf, Elias Ali
Mekhemar, Mohamed
Danso-Appiah, Anthony
Sofi-Mahmudi, Ahmad
Pérez-Gaxiola, Giordano
Dziedzic, Arkadiusz
Apóstolo, João
Cardoso, Daniela
Marc, Janja
Moreno-Casbas, Mayte
Wiysonge, Charles Shey
Qaseem, Amir
Gryschek, Anna
Tadić, Ivana
Hussain, Salman
Khan, Mohammed Ahmed
Klugarova, Jitka
Pokorna, Andrea
Koščík, Michal
Klugar, Miloslav
author_sort Riad, Abanoub
collection PubMed
description Background: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. Methods: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses’ side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. Conclusions: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.
format Online
Article
Text
id pubmed-8345554
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-83455542021-08-07 COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects Riad, Abanoub Schünemann, Holger Attia, Sameh Peričić, Tina Poklepović Žuljević, Marija Franka Jürisson, Mikk Kalda, Ruth Lang, Katrin Morankar, Sudhakar Yesuf, Elias Ali Mekhemar, Mohamed Danso-Appiah, Anthony Sofi-Mahmudi, Ahmad Pérez-Gaxiola, Giordano Dziedzic, Arkadiusz Apóstolo, João Cardoso, Daniela Marc, Janja Moreno-Casbas, Mayte Wiysonge, Charles Shey Qaseem, Amir Gryschek, Anna Tadić, Ivana Hussain, Salman Khan, Mohammed Ahmed Klugarova, Jitka Pokorna, Andrea Koščík, Michal Klugar, Miloslav Int J Environ Res Public Health Study Protocol Background: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. Methods: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses’ side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. Conclusions: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines. MDPI 2021-07-25 /pmc/articles/PMC8345554/ /pubmed/34360156 http://dx.doi.org/10.3390/ijerph18157859 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Riad, Abanoub
Schünemann, Holger
Attia, Sameh
Peričić, Tina Poklepović
Žuljević, Marija Franka
Jürisson, Mikk
Kalda, Ruth
Lang, Katrin
Morankar, Sudhakar
Yesuf, Elias Ali
Mekhemar, Mohamed
Danso-Appiah, Anthony
Sofi-Mahmudi, Ahmad
Pérez-Gaxiola, Giordano
Dziedzic, Arkadiusz
Apóstolo, João
Cardoso, Daniela
Marc, Janja
Moreno-Casbas, Mayte
Wiysonge, Charles Shey
Qaseem, Amir
Gryschek, Anna
Tadić, Ivana
Hussain, Salman
Khan, Mohammed Ahmed
Klugarova, Jitka
Pokorna, Andrea
Koščík, Michal
Klugar, Miloslav
COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects
title COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects
title_full COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects
title_fullStr COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects
title_full_unstemmed COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects
title_short COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects
title_sort covid-19 vaccines safety tracking (covast): protocol of a multi-center prospective cohort study for active surveillance of covid-19 vaccines’ side effects
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8345554/
https://www.ncbi.nlm.nih.gov/pubmed/34360156
http://dx.doi.org/10.3390/ijerph18157859
work_keys_str_mv AT riadabanoub covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT schunemannholger covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT attiasameh covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT pericictinapoklepovic covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT zuljevicmarijafranka covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT jurissonmikk covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT kaldaruth covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT langkatrin covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT morankarsudhakar covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT yesufeliasali covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT mekhemarmohamed covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT dansoappiahanthony covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT sofimahmudiahmad covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT perezgaxiolagiordano covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT dziedzicarkadiusz covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT apostolojoao covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT cardosodaniela covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT marcjanja covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT morenocasbasmayte covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT wiysongecharlesshey covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT qaseemamir covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT gryschekanna covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT tadicivana covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT hussainsalman covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT khanmohammedahmed covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT klugarovajitka covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT pokornaandrea covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT koscikmichal covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects
AT klugarmiloslav covid19vaccinessafetytrackingcovastprotocolofamulticenterprospectivecohortstudyforactivesurveillanceofcovid19vaccinessideeffects