COVID-19 Vaccines Safety Tracking (CoVaST)

April 5, 2022 updated by: Masaryk University

COVID-19 Vaccines Safety Tracking: Global Consortium Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In Phase A, a pragmatic approach will track each target group according to the governmental plan; in most countries, it went from HCW to OA to ST. The sample of Phase B will be pre-identified based on the outcome of Phase A. If ≥ 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest to join Phase B, no additional recruitment will be required. If < 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest in Phase B, additional recruitment will be carried out targeting healthcare workers who will receive booster doses. In case of the emergence of special side effects after booster doses, additional recruitment of healthcare workers will be required.

Description

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 informed consent independently.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pfizer-BioNTech COVID-19 Vaccine
Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)
Biological: BNT162b2
Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
Moderna COVID-19 Vaccine
Recently vaccinated individuals by Moderna COVID-19 Vaccine
Biological: mRNA-1273
Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
AstraZeneca-Oxford University COVID-19 Vaccine
Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria)
Biological: AZD1222
Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
CoronaVac
Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine)
Biological: CoronaVac
Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
Sinopharm
Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine)
Biological: Sinopharm
Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
Sputnik V
Recently vaccinated individuals by Sputnik V COVID-19 Vaccine
Biological: Gam-COVID-Vac
Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
Janssen
Recently vaccinated individuals by Janssen COVID-19 Vaccine
Biological: JNJ-78436735
Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
CureVac
Recently vaccinated individuals by CureVac COVID-19 Vaccine
Biological: CVnCoV
Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
Novavax
Recently vaccinated individuals by Novavax COVID-19 Vaccine
Biological: NVX-CoV2373
Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
Covaxin
Recently vaccinated individuals by Covaxin COVID-19 Vaccine
Biological: BBV152
Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
CanSino
Recently vaccinated individuals by CanSino COVID-19 Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Side Effects
Time Frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)
0-30 days after the COVID-19 vaccine shot
Systemic Side Effects
Time Frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)
0-30 days after the COVID-19 vaccine shot

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unrecognized Side Effects
Time Frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of oral and dermatologic side effects (e.g. oral paresthesia, oral ulcers, dysgeusia, skin rash, acne, urticaria, etc)
0-30 days after the COVID-19 vaccine shot

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoVaST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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