COVID-19 Vaccines Safety Tracking (CoVaST)

COVID19 Vaccine Clinical Trial

Official title:

COVID-19 Vaccines Safety Tracking: Global Consortium Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834869
• Other study ID #: CoVaST
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2021
• Source: Masaryk University
• Contact: Miloslav Klugar, PhD
• Phone: +420549495676
• Email: klugar[@]med.muni.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Reaction to Vaccine
• COVID-19
• COVID19 Vaccine

Intervention

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

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Croatia	University of Split	Split
Czechia	Masaryk University	Brno
Estonia	University of Tartu	Tartu
Ethiopia	Jimma University	Jimma
Germany	Justus-Liebig University Giessen	Giessen
Ghana	University of Ghana	Accra
Mexico	Sinaloa's Pediatric Hospital	Culiacán
Poland	Medical University of Silesia	Katowice
Portugal	Nursing School of Coimbra	Coimbra
Russian Federation	Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences	Irkutsk
Serbia	University of Belgrade	Belgrade
Slovenia	University of Ljubljana	Ljubljana
United States	American College of Physicians	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk University

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Czechia,  Estonia,  Ethiopia,  Germany,  Ghana,  Mexico,  Poland,  Portugal,  Russian Federation,  Serbia,  Slovenia, 

References & Publications (1)

Riad A, Pokorná A, Attia S, Klugarová J, Košcík 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). pii: 1428. doi: 10.3390/jcm10071428. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Side Effects	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
Primary	Systemic Side Effects	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	Unrecognized Side Effects	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