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Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina

Sponsor
Institute for Public Health of the Federation of Bosnia and Herzegovina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05124535
Collaborator
World Health Organization (Other)
1,152
Enrollment
1
Location
1.4
Anticipated Duration (Months)
796.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is the second cross-sectional study conducted in the region. In the first cross sectional study, conducted in the winter of 2020, we aimed to estimate the seroprevalence of SARS-CoV-2 IgG antibodies among blood donors in Sarajevo Canton. We also assessed immune durability among seropositive participants after 6 months. In total, of 1015 blood donors aged 18-65 years in Sarajevo Canton between 2 November and 3 December 2020 were recruited and population-weighted seroprevalence in Sarajevo Canton was 19.2% (95% CI: 16.7-21.6%). The aim of this second cross-sectional study is to measure the seroprevalence SARS-CoV-2 antibodies and assess antibody kinetics in the blood donor population after 12 months.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1152 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina
    Anticipated Study Start Date :
    Nov 17, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Persons aged 18-29
    Persons aged 30-39
    Persons aged 40-65

    Outcome Measures

    Primary Outcome Measures

    1. Seroprevalence of SARS-CoV-2 IgG antibodies [November 2021-December 2021]

      Crude seroprevalence among blood donors will be adjusted to age and sex distribution in cantonal population and to test sensitivity and specificity using Bayesian statistical modeling.

    Secondary Outcome Measures

    1. Assess factors associated with seropositivity. [November 2021-December 2021]

      Chi-squared test will be conducted on categorical variables.

    2. Assess antibody response across types of immunity. [November 2021-December 2021]

      Among those with positive anti-S antibodies, geometric mean titers will be compared across participants with natural immunity, vaccine-induced immunity, and hybrid of natural and vaccine-induced immunity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All individuals identified for recruitment into the investigation, resident of Canton Sarajevo between 18-65 years, irrespective of prior COVID-19 infection.
    Exclusion Criteria:
    • Refusal to give informed consent or to attend follow-up appointments; currently experiencing COVID-19 symptoms or in the last 14 days; and close contact with a confirmed case of COVID-19 within 14 days prior to donation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina Sarajevo Bosnia and Herzegovina 71000

    Sponsors and Collaborators

    • Institute for Public Health of the Federation of Bosnia and Herzegovina
    • World Health Organization

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute for Public Health of the Federation of Bosnia and Herzegovina
    ClinicalTrials.gov Identifier:
    NCT05124535
    Other Study ID Numbers:
    • 001
    First Posted:
    Nov 18, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Nov 18, 2021