COVID-19 Vaccines Safety Tracking (CoVaST)

Last updated: April 5, 2022
Sponsor: Masaryk University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04834869
CoVaST
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 30000
Study Start date:
April 01, 2021
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • McMaster University

    Hamilton, Ontario
    Canada

    Site Not Available

  • University of Split

    Split,
    Croatia

    Site Not Available

  • Masaryk University

    Brno,
    Czechia

    Active - Recruiting

  • University of Tartu

    Tartu,
    Estonia

    Site Not Available

  • Jimma University

    Jimma,
    Ethiopia

    Active - Recruiting

  • Justus-Liebig University Giessen

    Giessen,
    Germany

    Active - Recruiting

  • University of Ghana

    Accra,
    Ghana

    Site Not Available

  • National Institute for Medical Research Development (NIMAD)

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

  • Sinaloa's Pediatric Hospital

    Culiacán,
    Mexico

    Site Not Available

  • Sinaloa's Pediatric Hospital

    Sinaloa,
    Mexico

    Site Not Available

  • Medical University of Silesia

    Katowice,
    Poland

    Active - Recruiting

  • Nursing School of Coimbra

    Coimbra,
    Portugal

    Site Not Available

  • Carol Davila University

    Bucharest,
    Romania

    Site Not Available

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

    Irkutsk, 664033
    Russian Federation

    Active - Recruiting

  • University of Belgrade

    Belgrade, 11221
    Serbia

    Active - Recruiting

  • University of Ljubljana

    Ljubljana,
    Slovenia

    Site Not Available

  • Carlos III Health Institute

    Madrid,
    Spain

    Site Not Available

  • American College of Physicians

    Philadelphia, Pennsylvania 19106
    United States

    Site Not Available

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