COVID-19 Vaccines Safety Tracking (CoVaST)

Официальное название

COVID-19 Vaccines Safety Tracking: Global Consortium Study

Обзор

This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.

Подробное описание

Introduction:

COVID-19 vaccines are the foremost asset to overcome the ongoing pandemic; therefore, mass vaccination has become a high priority for the world's governments. While vaccination strategies need to be accelerated to minimise daily fatalities and relieve the pandemic's economic burdens, vaccine hesitancy (VH) remains a serious challenge for these efforts. VH refers to "delay in acceptance or refusal of vaccines despite availability of vaccine services",; and it is an emerging public health challenge nourished by misinformation related to vaccines effectiveness and safety. Aversion to vaccines' potential side effects is the most frequent cause of VH among population groups. Therefore, a recent systematic review revealed that raising public awareness of vaccines' effectiveness and side effects is vital for improving vaccine uptake.

Public health systems globally experience a novel and unique challenge due to the variety of vaccines manufacturers and the high levels of public awareness about those manufacturers and their marketing strategies. This unprecedented situation is predicted to create what we can refer to as "vaccine selectivity, " increasing the pressure on our weakened health systems and economies and increasing vaccine hesitancy levels. Independent (non-sponsored) studies with rigorous methods can perfectly lead the pharmacovigilance efforts of COVID-19 vaccines globally. Given their independent nature and transparent design, these studies can play a key role in suppressing vaccine hesitancy levels by enhancing public confidence in vaccines.

Design

This project comprises two phases; a) a cross-sectional survey for the short-term side effects of COVID-19 vaccines; b) a prospective cohort study for the long-term safety of COVID-19 vaccines.

Phase A:

A validated self-administered questionnaire will be developed and delivered online to the target population groups (HCW, OA \& ST). The questionnaire will be inquiring about the short-term side effects that emerged within 30 days following the vaccine shot (either the first or the second dose). The side effects will be classified as local or systemic, and their onset, duration, and intensity will be self-assessed and self-reported by the respondents. This phase is proposed to take place until December 31st, 2021.

Phase B:

A validated self-administered questionnaire will be developed and delivered online to the volunteers who participated in Phase A and expressed their interest to report their long-term side effects. In this phase, the vaccine effectiveness and side effects will be evaluated after booster doses. Phase B will take place for five consecutive years starting from 2022.

Вмешательства

• Биопрепарат BNT162b2
  Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
• Биопрепарат mRNA-1273
  Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
• Биопрепарат AZD1222
  Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
• Биопрепарат CoronaVac
  Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
• Биопрепарат Sinopharm
  Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
• Биопрепарат Gam-COVID-Vac
  Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
• Биопрепарат JNJ-78436735
  Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
• Биопрепарат CVnCoV
  Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
• Биопрепарат NVX-CoV2373
  Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
• Биопрепарат BBV152
  Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)

Первичные конечные точки

• Local Side Effects [Срок оценки: 0-30 days after the COVID-19 vaccine shot]
• Systemic Side Effects [Срок оценки: 0-30 days after the COVID-19 vaccine shot]

Вторичные конечные точки (1)

• Unrecognized Side Effects [Срок оценки: 0-30 days after the COVID-19 vaccine shot]

Критерии участия

Критерии включения

• HCW, OA and ST who received COVID-19 vaccine.
• Participating subjects should be at least 18-year-old and able to give their informed consent independently.

Критерии исключения

• Non HCW, OA and ST who received the COVID-19.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• American College of Physicians — Philadelphia

Канада · 1 центр

• McMaster University — Hamilton

Хорватия · 1 центр

• University of Split — Split

Чехия · 1 центр

• Masaryk University — Brno

Эстония · 1 центр

• University of Tartu — Tartu

Ethiopia · 1 центр

• Jimma University — Jimma

Германия · 1 центр

• Justus-Liebig University Giessen — Giessen

Ghana · 1 центр

• University of Ghana — Accra

Мексика · 1 центр

• Sinaloa's Pediatric Hospital — Culiacán

Польша · 1 центр

• Medical University of Silesia — Katowice

Португалия · 1 центр

• Nursing School of Coimbra — Coimbra

Россия · 1 центр

• Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences — Irkutsk

Сербия · 1 центр

• University of Belgrade — Belgrade

Словения · 1 центр

• University of Ljubljana — Ljubljana

Публикации

• Riad A, Pokorna A, Attia S, Klugarova J, Koscik M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7):1428. doi: 10.3390/jcm10071428. PMID 33916020
• Riad A, Schunemann H, Attia S, Pericic TP, Zuljevic MF, Jurisson M, Kalda R, Lang K, Morankar S, Yesuf EA, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Perez-Gaxiola G, Dziedzic A, Apostolo J, Cardoso D, Marc J, Moreno-Casbas M, Wiysonge CS, Qaseem A, Gryschek A, Tadic I, Hussain S, Khan MA, Klugarova J, Pokorna A, Koscik M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi- PMID 34360156

Идентификаторы

NCT: NCT04834869 · CoVaST

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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