Clinical trial NCT04811391: COVID-19 Vaccine Effectiveness in Albanian Health Workers
Official title: Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Albania
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: vaccine effectiveness
health care worker
Albania
Lead sponsor: Institute of Public Health, Albania
Sponsor class: OTHER_GOV
Collaborators: name: World Health Organization
name: Centers for Disease Control and Prevention
name: Southeast Europe Center for Infectious Diseases Surveillance and Control
name: EPICONCEPT
First posted: 2021-03-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: COVID-19 vaccine effectiveness
timeFrame: 12 months
measure: COVID-19 PCR confirmation
timeFrame: 12 months
Secondary outcomes:
measure: Vaccine effectiveness by age
timeFrame: 12 months
measure: Vaccine effectiveness by co-morbidities
timeFrame: 12 months
Other outcomes:
Locations:
city: Durrës
country: Albania
facility: Durres Regional Hospital
city: Fier
country: Albania
facility: Fier Regional Hospital
city: Tirana
country: Albania
facility: Tirana University Hospital " Mother Theresa"
Study officials:
affiliation: Institute of Public Health
name: Silvia Bino, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.