COVID-19 Vaccine Effectiveness in Albanian Health Workers

Covid19 Clinical Trial

— COVEAL  

Official title:

Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Albania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04811391
• Other study ID #: COV-VE-0001
• Status: Recruiting
• Start date: February 19, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: March 2021
• Source: Institute of Public Health, Albania
• Contact: Iria Preza, MPH
• Phone: +355 699672570
• Email: iria.preza[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Albania	Durres Regional Hospital	Durrës
Albania	Fier Regional Hospital	Fier
Albania	Tirana University Hospital " Mother Theresa"	Tirana

Sponsors (5)

Lead Sponsor	Collaborator
Institute of Public Health, Albania	Centers for Disease Control and Prevention, EPICONCEPT, Southeast Europe Center for Infectious Diseases Surveillance and Control, World Health Organization

Country where clinical trial is conducted

Albania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Vaccine effectiveness by age	The enrollment questionnaire includes age of each participant. Data will be stratified by age at the time of analysis.	12 months
Secondary	Vaccine effectiveness by co-morbidities	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.	12 months