COVID-19 Vaccine Effectiveness in Albanian Health Workers

Overview

The purpose of this study is to evaluate the effectiveness of the COVID-19 vaccine in hospital based HWs in Albania. This will answer critical questions about the real-world performance of COVID-19 vaccines in one of the key target groups for vaccination.

Full Title of Study: “Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Albania”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 20, 2022

Detailed Description

This protocol describes a prospective one-year cohort study of hospital-based health workers in Albania to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID -19 disease. The investigators will measure the effectiveness of COVID-19 vaccines against laboratory-confirmed SARS-CoV-2 infection in both symptomatic and asymptomatic hospital health workers. SARS-CoV-2 infection will be diagnosed using symptom questionnaires and PCR testing. Additionally, serology testing will be obtained over the course of one year, to identify asymptomatic infections.

Interventions

  • Biological: COVID-19 vaccine
    • Observation of individuals who receive the COVID-19 vaccine (2 doses of PfizerBioNtech COVID-19 vaccine).

Arms, Groups and Cohorts

  • Vaccinated participants
    • Participants who have received 2 doses of the pfizer Covid-19 vaccine or 1 or dose of the Astra Zeneca Covid-19 Vaccine
  • Unvaccinated participants
    • Have not received any doses of any form of COVID-19 vaccine

Clinical Trial Outcome Measures

Primary Measures

  • COVID-19 vaccine effectiveness
    • Time Frame: 12 months
    • Data will be collected using weekly symptom questionnaires, COVID-19 PCR confirmation for any symptomatic participant and quarterly serology assessment for all participants to identify N-protein presents to suggest new infection, rather than vaccine induced antibody response.
  • COVID-19 PCR confirmation
    • Time Frame: 12 months
    • Data will be collected using weekly symptom questionnaires, COVID-19 PCR confirmation for any symptomatic participant and quarterly serology assessment for all participants to identify N-protein presents to suggest new infection, rather than vaccine induced antibody response.

Secondary Measures

  • Vaccine effectiveness by age
    • Time Frame: 12 months
    • The enrollment questionnaire includes age of each participant. Data will be stratified by age at the time of analysis.
  • Vaccine effectiveness by co-morbidities
    • Time Frame: 12 months
    • The enrollment questionnaire will include specific co-morbidities, including (but not limited to) heart disease, autoimmune disease, chronic liver disease and chronic kidney disease. Data will be stratified by co-morbidity at the time of analysis.

Participating in This Clinical Trial

Inclusion Criteria

  • All Health Workers eligible to receive the COVID-19 vaccination according to the national guidelines of Institute of Public Health. – Health Workers working at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital. – Health Workers who have already been vaccinated against COVID-19 as part of the early COVID-19 vaccine rollout can be included, as long as information can be collected about the date and type of the vaccine that was administered. However, priority will be given to enrolling Health Workers who have received their COVID vaccine no more than 4 days prior to the day of enrolment in the study. Exclusion Criteria:

  • Health Workers who are not eligible for COVID-19 vaccination or have a contraindication to vaccination should not participate in the study. – Health Workers who do not work at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Institute of Public Health, Albania
  • Collaborator
    • World Health Organization
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Silvia Bino, MD, PHD, Principal Investigator, Institute of Public Health
  • Overall Contact(s)
    • Iria Preza, MPH, +355 699672570, iria.preza@gmail.com

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