Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Centers for Disease Control and Prevention | FED |
| Southeast Europe Center for Infectious Diseases Surveillance and Control | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 vaccine | Biological | Observation of individuals who receive the COVID-19 vaccine (2 doses of PfizerBioNtech COVID-19 vaccine). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Vaccine effectiveness by co-morbidities |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iria Preza, MPH | Contact | +355 699672570 | iria.preza@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Bino, MD, PHD | Institute of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durres Regional Hospital | Recruiting | Durrës | Albania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37885795 | Derived | 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. | |
| 35321895 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| EPICONCEPT |
| UNKNOWN |
Not provided
Not provided
Not provided
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 |
| Fier Regional Hospital | Recruiting | Fier | Albania |
|
| Tirana University Hospital " Mother Theresa" | Recruiting | Tirana | 1015 | Albania |
|
| Derived |
| Sridhar 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |