COVID-19 Vaccine Effectiveness in Albanian Health Workers

Institute of Public Health, Albania1,500 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Covid19

Interventions

COVID-19 vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Durres Regional Hospital

Durrës, Albania

RECRUITING

Fier Regional Hospital

Fier, Albania

RECRUITING

Tirana University Hospital " Mother Theresa"

Tirana, Albania

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

COVID-19 PCR confirmation

Time frame: 12 months

Secondary Outcomes

Vaccine effectiveness by age

The enrollment questionnaire includes age of each participant. Data will be stratified by age at the time of analysis.

Time frame: 12 months

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.

Time frame: 12 months

Central Contacts

Iria Preza, MPH

CONTACT

+355 699672570 iria.preza@gmail.com

Data from ClinicalTrials.gov

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