Clinical Trials Logo

Clinical Trial Summary

In January 2021, the vaccination campaign against coronavirus disease 2019 (COVID-19) started in Belgium. The vaccination campaign was conducted in several phases, with the first phase targeting priority groups starting in January 2021. The second phase began in June 2021 with the invitation of everyone aged 18 years and older before extending access to 12 years and older from summer 2021. Children aged 5-11 were also invited for vaccination from December 2021 onwards. The presence of a social gradient in COVID-19 infections and subsequent outcomes has been clearly demonstrated. Individuals from lower socioeconomic groups, for example with lower income, lower education level or unemployed are more likely to be infected by the SARS-CoV-2 and to develop severe complications after the infection such as hospitalization, ICU admission or death. Certain sociodemographic characteristics such as male gender, older age, living in crowded households, or belonging to ethnic/racial minorities are also associated with a higher risk of COVID-19 infection and severe outcomes. In addition to disparities in infection, hospitalization and mortality, some studies have also documented a lower COVID-19 vaccination coverage among people from disadvantaged socioeconomic groups during COVID-19 pandemic. Despite widespread vaccine promotion efforts and the fact that Belgium has the 7th highest full vaccine coverage in the European Union (89% of people over 18 years old had completed their primary course of vaccination on 08 April 2022), concerns regarding vaccine equity remain. Vaccine uptake depends on a range of factors, including the socio-cultural environment, pre-existing health needs and individual choice. Identifying differences in vaccination between population groups is crucial to assess the effectiveness of the vaccination strategy in Belgium and its relationship to the further spread of COVID-19. Our objective is to identify whether vaccination coverage has been equitable across Belgium and, if not, which groups of individuals are less likely to be covered by the COVID-19 vaccine, with respect to their sociodemographic (SD) and socioeconomic (SE) characteristics. This study therefore aims to highlight SD and SE disparities in the uptake of the first dose of COVID-19 vaccine in Belgium among people of 18 years and over.


Clinical Trial Description

1. Study design and data sources In this retrospective cohort study, we investigated SE and SD disparities in the uptake of the first COVID-19 vaccine dose using data from the LINK-VACC project. This project was launched by Sciensano, the institute legally responsible for the surveillance of infectious diseases in Belgium (Royal Decree of 21/03/2018), to perform the post-authorization surveillance of COVID-19 vaccines in Belgium. To that aim, selected variables from multiple existing national health and social sector registries were linked at an individual level using the unique Belgian social security number. The databases were linked within a pseudonymised environment hosted by Healthdata.be of Sciensano. For the present study, four databases were used : - Vaccinnet+, the Belgian vaccine registry, which contains information on all COVID-19 vaccine doses administrated in Belgium. It includes demographical data of the vaccinated person (sex, age, postal code of residence), as well as data on the vaccinator (type (person or organization) and postal code) and on the administrated vaccine (brand of the vaccine, lot number, date of administration, date of registration). - The COVID-19 Healthdata database containing data from COVID-19 laboratory tests performed in Belgium (data of sampling and test result). - The STATBEL database provided by the Belgian Statistical Institute which contains variables related to socioeconomic and sociodemographic characteristics. - The Common Base Registry for HealthCare Actor (CoBRHA) allowing the identification (by profession and specialty) of people who have been licensed to practice a healthcare profession in Belgium. 2. Cohort definition The population of interest includes all individuals of 18 years and older tested for COVID-19 at least once in Belgium until the 31st of August 2021 (which is the date of linkage between STATBEL, Vaccinnet+ and the COVID-19 Healthdata database) for whom SD and SE information from STATBEL database was available. The cohort is built from Vaccinnet+ and the COVID-19 Healthdata database which includes all doses of vaccines administered and PCR and rapid antigenic tests performed in Belgium, respectively. As of 31 August 2021, 10 475 908 individuals had been tested and/or vaccinated at least once in Belgium according to Vaccinnet+ and the COVID-19 Healthdata database. On January 1, 2021, the official Belgian population included 11 521 238 inhabitants, demonstrating a high coverage of the total Belgian population by these two data sources (90.92%). The relevant SE and SD variables were then included after linking with STATBEL database based on the individual national identification number. The data source available from STATBEL contains SE and SD information for 10 309 300/10 475 908 individuals registered at least once either in Vaccinnet+ from 28 December 2020 to 31 August 2021 or in the COVID-19 Healthdata database before 31 August 2021, corresponding to a linkage rate of 98.41%. Information on the healthcare license available in CoBRHA were then added. After these linkages, we excluded people who were deregistered, migrated and deceased based on their status in the national registry. We also excluded people whose age, region or gender were unknown. In order to be able to compare vaccination rate according to each SE and SD indicators, we included only individuals tested before 31 August 2021 since it is the date of linkage between Vaccinnet+, COVID-19 Healthdata database and STATBEL. Finally, we excluded individuals under 18 years of age as they were considered as a group in their own right in the vaccination strategy by being vaccinated the latest in a separate phase of the vaccination campaign. Our final cohort for this study is therefore composed of 5 341 584 individuals of 18 years and over tested in Belgium until the 31st of August 2021. 3. Outcome Our outcome variable, provided by Vaccinnet+, is the uptake of the first dose of COVID-19 vaccine until the 31st of August 2021. We considered that, at this date, all individuals over 18 years of age had received an invitation to be vaccinated with the first dose and had the opportunity to receive this dose of vaccine in Belgium. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05373420
Study type Observational
Source Sciensano
Contact
Status Completed
Phase
Start date December 28, 2020
Completion date August 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Active, not recruiting NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05191394 - IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES. N/A
Active, not recruiting NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Active, not recruiting NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Enrolling by invitation NCT05089305 - Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection Phase 2
Recruiting NCT04528901 - Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Recruiting NCT04357990 - Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 N/A
Active, not recruiting NCT04527471 - Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05047445 - A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection Phase 1
Recruiting NCT05041907 - Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Phase 2
Active, not recruiting NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Not yet recruiting NCT04990466 - Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. Phase 2/Phase 3
Recruiting NCT05323799 - The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)