COVID-19 Vaccine Effectiveness in Albanian Health Workers

NCT ID: NCT04811391

Last Updated: 2021-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-19

Study Completion Date

2022-05-20

Brief Summary

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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

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

COVID-19 vaccine

Intervention Type BIOLOGICAL

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

Unvaccinated participants

Have not received any doses of any form of COVID-19 vaccine

No interventions assigned to this group

Interventions

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COVID-19 vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Southeast Europe Center for Infectious Diseases Surveillance and Control

UNKNOWN

Sponsor Role collaborator

EPICONCEPT

UNKNOWN

Sponsor Role collaborator

Institute of Public Health, Albania

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvia Bino, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Institute of Public Health

Locations

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Durres Regional Hospital

Durrës, , Albania

Site Status RECRUITING

Fier Regional Hospital

Fier, , Albania

Site Status RECRUITING

Tirana University Hospital " Mother Theresa"

Tirana, , Albania

Site Status RECRUITING

Countries

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Albania

Central Contacts

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Iria Preza, MPH

Role: CONTACT

+355 699672570

Facility Contacts

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Iria Preza, MPH

Role: primary

+355 699672570

Iria Preza, MPH

Role: primary

+355 699672570

Iria Preza, MPH

Role: primary

+355 699672570

References

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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.

Reference Type DERIVED
PMID: 37885795 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35321895 (View on PubMed)

Other Identifiers

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COV-VE-0001

Identifier Type: -

Identifier Source: org_study_id

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