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. 2022 Mar 23;12(3):e057741.
doi: 10.1136/bmjopen-2021-057741.

COVID-19 vaccine effectiveness among healthcare workers in Albania (COVE-AL): protocol for a prospective cohort study and cohort baseline data

Shela Sridhar  1 , Albana Fico  2 , Iria Preza  2 , Iris Hatibi  2 , Jonilda Sulo  3 , Esther Kissling  4 , Rovena Daja  2 , Rawi Ibrahim  5 , Diogo Lemos  5 , Julia Rubin-Smith  6 , Alexis Schmid  6 , Adela Vasili  2 , Marta Valenciano  7 , Pernille Jorgensen  5 , Richard Pebody  5 , Kathryn E Lafond  8 , Mark A Katz  5 , Silvia Bino  9
Affiliations

COVID-19 vaccine effectiveness among healthcare workers in Albania (COVE-AL): protocol for a prospective cohort study and cohort baseline data

Shela Sridhar et al. BMJ Open. .

Abstract

Introduction: Critical questions remain about COVID-19 vaccine effectiveness (VE) in real-world settings, particularly in middle-income countries. We describe a study protocol to evaluate COVID-19 VE in preventing laboratory-confirmed SARS-CoV-2 infection in health workers (HWs) in Albania, an upper-middle-income country.

Methods and analysis: In this 12-month prospective cohort study, we enrolled HWs at three hospitals in Albania. HWs are vaccinated through the routine COVID-19 vaccine campaign. Participants completed a baseline survey about demographics, clinical comorbidities, and infection risk behaviours. Baseline serology samples were also collected and tested against the SARS-CoV-2 spike protein, and respiratory swabs were collected and tested for SARS-CoV-2 by RT-PCR. Participants complete weekly symptom questionnaires and symptomatic participants have a respiratory swab collected, which is tested for SARS-CoV-2. At 3, 6, 9 months and 12 months of the study, serology will be collected and tested for antibodies against the SARS-CoV-2 nucleocapsid protein and spike protein. VE will be estimated using a piecewise proportional hazards model (VE=1-HR).

Baseline data: From February to May 2021, 1504 HWs were enrolled. The median age was 44 (range: 22-71) and 78% were female. At enrolment, 72% of participants were seropositive for SARS-CoV-2. 56% of participants were vaccinated with one dose, of whom 98% received their first shot within 4 days of enrolment. All HWs received the Pfizer BNT162b2 mRNA COVID-19 vaccine.

Ethics and dissemination: The study protocol and procedures were reviewed and approved by the WHO Ethical Review Board, reference number CERC.0097A, and the Albanian Institute of Public Health Ethical Review Board, reference number 156. All participants have provided written informed consent to participate in this study. The primary results of this study will be published in a peer-reviewed journal at the time of completion.

Trial registration number: NCT04811391.

Keywords: COVID-19; infection control; public health.

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Conflict of interest statement

Competing interests: None declared.

References

    1. Dagan N, Barda N, Kepten E, et al. . BNT162b2 mRNA Covid-19 vaccine in a nationwide mass vaccination setting. N Engl J Med Overseas Ed 2021;384:1412–23. 10.1056/NEJMoa2101765 - DOI - PMC - PubMed
    1. Patel MM, Jackson ML, Ferdinands J. Postlicensure evaluation of COVID-19 vaccines. JAMA 2020;324:1939. 10.1001/jama.2020.19328 - DOI - PubMed
    1. Grenham A, Villafana T. Vaccine development and trials in low and lower-middle income countries: key issues, advances and future opportunities. Hum Vaccin Immunother 2017;13:2192–9. 10.1080/21645515.2017.1356495 - DOI - PMC - PubMed
    1. Hall VJ, Foulkes S, Charlett A, et al. . SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN). The Lancet 2021;397:1459–69. 10.1016/S0140-6736(21)00675-9 - DOI - PMC - PubMed
    1. Benenson S, Oster Y, Cohen MJ, et al. . BNT162b2 mRNA Covid-19 vaccine effectiveness among health care workers. N Engl J Med 2021;384:1775–7. 10.1056/NEJMc2101951 - DOI - PMC - PubMed

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