COVID-19 Vaccine Effectiveness in Albanian Health Workers
COVEAL
Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Albania
1 other identifier
observational
1,500
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2021
CompletedFirst Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedMarch 26, 2021
March 1, 2021
1.2 years
March 19, 2021
March 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
COVID-19 vaccine effectiveness
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.
12 months
COVID-19 PCR confirmation
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.
12 months
Secondary Outcomes (2)
Vaccine effectiveness by age
12 months
Vaccine effectiveness by co-morbidities
12 months
Study Arms (2)
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
Interventions
Observation of individuals who receive the COVID-19 vaccine (2 doses of PfizerBioNtech COVID-19 vaccine).
Eligibility Criteria
The study population will be composed of health workers in the above hospitals, eligible for vaccination, with no contraindication to receive COVID-19 vaccine. Health Workers include all categories of staff working in the hospitals, including clinical and non-clinical/administrative staff and staff with direct patient interaction and those without direct patient interaction.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Public Health, Albanialead
- World Health Organizationcollaborator
- Centers for Disease Control and Preventioncollaborator
- Southeast Europe Center for Infectious Diseases Surveillance and Controlcollaborator
- EPICONCEPTcollaborator
Study Sites (3)
Durres Regional Hospital
Durrës, Albania
Fier Regional Hospital
Fier, Albania
Tirana University Hospital " Mother Theresa"
Tirana, 1015, Albania
Related Publications (2)
Finci I, Rojas Castro MY, Hasibra I, Sulo J, Fico A, Daja R, Vasili A, Kota M, Preza I, Muhlemann B, Drosten C, Pebody R, Lafond KE, Kissling E, Katz MA, Bino S. Primary Series and Booster Coronavirus Disease 2019 Vaccine Effectiveness in a Cohort of Healthcare Workers in Albania During a BA.1 and BA.2 Variant Period, January-May 2022. Open Forum Infect Dis. 2023 Oct 12;10(10):ofad479. doi: 10.1093/ofid/ofad479. eCollection 2023 Oct.
PMID: 37885795DERIVEDSridhar S, Fico A, Preza I, Hatibi I, Sulo J, Kissling E, Daja R, Ibrahim R, Lemos D, Rubin-Smith J, Schmid A, Vasili A, Valenciano M, Jorgensen P, Pebody R, Lafond KE, Katz MA, Bino S. COVID-19 vaccine effectiveness among healthcare workers in Albania (COVE-AL): protocol for a prospective cohort study and cohort baseline data. BMJ Open. 2022 Mar 23;12(3):e057741. doi: 10.1136/bmjopen-2021-057741.
PMID: 35321895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Bino, MD, PHD
Institute of Public Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 23, 2021
Study Start
February 19, 2021
Primary Completion
May 20, 2022
Study Completion
May 20, 2022
Last Updated
March 26, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share