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COVID-19 Vaccines Safety Tracking (CoVaST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04834869
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Masaryk University

Study Description
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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.

Condition or disease Intervention/treatment
Adverse Reaction to Vaccine COVID19 Vaccine Biological: BNT162b2 Biological: mRNA-1273 Biological: AZD1222 Biological: CoronaVac Biological: Sinopharm Biological: Gam-COVID-Vac Biological: JNJ-78436735 Biological: CVnCoV Biological: NVX-CoV2373 Biological: BBV152

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 Design
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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: COVID-19 Vaccines Safety Tracking: Global Consortium Study
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834869


Contacts
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Contact: Miloslav Klugar, PhD +420549495676 klugar@med.muni.cz
Contact: Abanoub Riad, DDS +420549496572 abanoub.riad@med.muni.cz

Locations
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United States, Pennsylvania
American College of Physicians Not yet recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Amir Qassem, MD, PhD       aqaseem@acponline.org   
Canada, Ontario
McMaster University Not yet recruiting
Hamilton, Ontario, Canada
Contact: Holger Schünemann, MD, PhD       schuneh@mcmaster.ca   
Croatia
University of Split Not yet recruiting
Split, Croatia
Contact: Tina Poklepović Peričić, DDS, PhD       tinapoklepovic@gmail.com   
Contact: Marija Franka Žuljević, MD       marija.franka@gmail.com   
Czechia
Masaryk University Recruiting
Brno, Czechia
Contact: Miloslav Klugar, PhD       klugar@med.muni.cz   
Contact: Abanoub Riad, DDS       abanoub.riad@med.muni.cz   
Estonia
University of Tartu Not yet recruiting
Tartu, Estonia
Contact: Mikk Jürisson, MD, PhD       mikk.jurisson@ut.ee   
Contact: Ruth Klada, MD, PhD       ruth.kalda@ut.ee   
Sub-Investigator: Katrin Lang, MD, PhD         
Ethiopia
Jimma University Recruiting
Jimma, Ethiopia
Contact: Morankar Sudhakar, PhD       morankarsn@yahoo.com   
Contact: Elias Yesuf, MD, PhD       elias.yesuf@gmail.com   
Germany
Justus-Liebig University Giessen Recruiting
Giessen, Germany
Contact: Sameh Attia, DDS       Sameh.Attia@dentist.med.uni-giessen.de   
Ghana
University of Ghana Not yet recruiting
Accra, Ghana
Contact: Anthony Danso-Appiah, PhD       adanso-appiah@ug.edu.gh   
Mexico
Sinaloa's Pediatric Hospital Not yet recruiting
Culiacán, Mexico
Contact: Giordano Pérez-Gaxiola, MD, MSc       giordano@cochrane.mx   
Poland
Medical University of Silesia Recruiting
Katowice, Poland
Contact: Arkadiusz Dziedzic, DDS, PhD       adziedzic@sum.edu.pl   
Portugal
Nursing School of Coimbra Not yet recruiting
Coimbra, Portugal
Contact: João Apóstolo, PhD       apostolo@esenfc.pt   
Russian Federation
Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences Recruiting
Irkutsk, Russian Federation, 664033
Contact: Konstantin Apartsin, MD, PhD       director@isc.irk.ru   
Serbia
University of Belgrade Recruiting
Belgrade, Serbia, 11221
Contact: Ivana Tadić, PhD       ivana.tadic@pharmacy.bg.ac.rs   
Contact: Marina Odalović, PhD       marina.odalovic@pharmacy.bg.ac.rs   
Slovenia
University of Ljubljana Not yet recruiting
Ljubljana, Slovenia
Contact: Janja Marc, PharmD       janja.marc@ffa.uni-lj.si   
Sponsors and Collaborators
Masaryk University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Masaryk University
ClinicalTrials.gov Identifier: NCT04834869    
Other Study ID Numbers: CoVaST
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Masaryk University:
COVID-19
Vaccines
Safety
Side Effects
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases