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

• Conditions: Seroprevalence; Antibody; COVID-19

• Registration Number: NCT05124535
• Lead Sponsor: Institute for Public Health of the Federation of Bosnia and Herzegovina

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study Start: 2021-11-17
• Study First Posted: 2021-11-18
• Last Update Posted: 2021-11-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1152

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assess factors associated with seropositivity.	November 2021-December 2021	Chi-squared test will be conducted on categorical variables.
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.

Trial Locations

Locations (1)

Institute for Transfusion Medicine of the Federation of Bosnia and Herzegovina; 🇧🇦 Sarajevo, Bosnia and Herzegovina