COVID-19 Vaccines Safety Tracking (CoVaST)

Overview

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.

Full Title of Study: “COVID-19 Vaccines Safety Tracking: Global Consortium Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • Pfizer-BioNTech COVID-19 Vaccine
    • Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)
  • Moderna COVID-19 Vaccine
    • Recently vaccinated individuals by Moderna COVID-19 Vaccine
  • AstraZeneca-Oxford University COVID-19 Vaccine
    • Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria)
  • CoronaVac
    • Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine)
  • Sinopharm
    • Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine)
  • Sputnik V
    • Recently vaccinated individuals by Sputnik V COVID-19 Vaccine
  • Janssen
    • Recently vaccinated individuals by Janssen COVID-19 Vaccine
  • CureVac
    • Recently vaccinated individuals by CureVac COVID-19 Vaccine
  • Novavax
    • Recently vaccinated individuals by Novavax COVID-19 Vaccine
  • Covaxin
    • Recently vaccinated individuals by Covaxin COVID-19 Vaccine

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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 Measures

  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Masaryk University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Miloslav Klugar, PhD, +420549495676, klugar@med.muni.cz

References

Riad A, Pokorná A, Attia S, Klugarová J, Koščík 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.

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