COVID-19 Vaccines Safety Tracking (CoVaST)

Recruiting

• Conditions: Adverse Reaction to Vaccine; COVID19 Vaccine
• Interventions: Biological: Sinopharm; Biological: CVnCoV; Biological: BNT162b2; Biological: CoronaVac; Biological: mRNA-1273; Biological: AZD1222; Biological: Gam-COVID-Vac; Biological: JNJ-78436735; Biological: NVX-CoV2373; Biological: BBV152

• Registration Number: NCT04834869
• Lead Sponsor: Masaryk University

Brief 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.

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Status Verified: 2021-10
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30000

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sinopharm	Sinopharm	Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine)
CureVac	CVnCoV	Recently vaccinated individuals by CureVac COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine	BNT162b2	Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)
CoronaVac	CoronaVac	Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine)
Moderna COVID-19 Vaccine	mRNA-1273	Recently vaccinated individuals by Moderna COVID-19 Vaccine
AstraZeneca-Oxford University COVID-19 Vaccine	AZD1222	Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria)
Sputnik V	Gam-COVID-Vac	Recently vaccinated individuals by Sputnik V COVID-19 Vaccine
Janssen	JNJ-78436735	Recently vaccinated individuals by Janssen COVID-19 Vaccine
Novavax	NVX-CoV2373	Recently vaccinated individuals by Novavax COVID-19 Vaccine
Covaxin	BBV152	Recently vaccinated individuals by Covaxin COVID-19 Vaccine

Primary Outcome Measures

Name	Time	Method
Local Side Effects	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)
Systemic Side Effects	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)

Secondary Outcome Measures

Name	Time	Method
Unrecognized Side Effects	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)

Trial Locations

Locations (14)

University of Ljubljana; 🇸🇮 Ljubljana, Slovenia

American College of Physicians; 🇺🇸 Philadelphia, Pennsylvania, United States

Masaryk University; 🇨🇿 Brno, Czechia

Justus-Liebig University Giessen; 🇩🇪 Giessen, Germany

Nursing School of Coimbra; 🇵🇹 Coimbra, Portugal

Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences; 🇷🇺 Irkutsk, Russian Federation

University of Belgrade; 🇷🇸 Belgrade, Serbia

University of Tartu; 🇪🇪 Tartu, Estonia

Jimma University; 🇪🇹 Jimma, Ethiopia

University of Ghana; 🇬🇭 Accra, Ghana

Sinaloa's Pediatric Hospital; 🇲🇽 Culiacán, Mexico

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

University of Split; 🇭🇷 Split, Croatia

Medical University of Silesia; 🇵🇱 Katowice, Poland