Sars-COV-2 (COVID-19) Immunity in immunoCOmpromised Populations (COVICO)

April 26, 2024 updated by: Maria Goossens

Longitudinal Follow-up of SARS-CoV-2 (COVID-19) Immunity in Immunocompromised Populations in Belgium (COVICO) in Nursing Home Residents and Staff During the Winter Season 2022-2023

The immune response of COVID-19 vaccination was monitored and studied in the context of the previously PICOV study (P2020/424), Nephro- VAC studies (P2020/284 and P2020/312) and Lung-VAC study (P2021/182). The constant emergence of new variants of concern (VOCs), which become increasingly better at escaping infection and vaccine induced immune responses, together with waning immunity over time, warrant additional vaccination rounds. This is especially true in immunocompromised populations.

In the current study, we want to continue monitoring SARS-CoV-2 specific immunity over the next two years, encompassing several future vaccination campaigns.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: In collaboration with several Belgian universities, hospitals and institutes, Sciensano, the Belgian Scientific Institute of Public Health, set up a consortium to facilitate and streamline the organization of COVID-19 vaccination studies primarily in immunocompromised populations. The immune response of COVID-19 vaccination was monitored and studied in the context of the previously PICOV study (P2020/424), Nephro- VAC studies (P2020/284 and P2020/312) and Lung-VAC study (P2021/182). The constant emergence of new variants of concern (VOCs), which become increasingly better at escaping infection and vaccine induced immune responses, together with waning immunity over time, warrant additional vaccination rounds. This is especially true in immunocompromised populations.

In the current study, we want to continue monitoring SARS-CoV-2 specific immunity over the next two years, encompassing several future vaccination campaigns.

Method: A non-commercial multicenter academic prospective cohort study will be conducted in immunocompromised populations and healthy adults for two years. These healthy people will be recruited from the previously organized PICOV-VAC study (members of nursing home staff) (EudraCT 2021-000401-24) and REDU-VAC study (EudraCT 2021-002088-23) while the immunocompromised participants will be recruited from the previously established PICOV-VAC, REDU-VAC, Lung-VAC and Nephro-VAC cohorts from which historic clinic and immunologic data is available. Participants will be sampled three times a year independently of the vaccinations which will be administered through regular channels not linked to the study itself.

Objectives: The main goal of this study is to measure levels of immunity in healthy adults and immunocompromised participants three times a year. The primary objective is to determine binding and neutralizing antibody levels against the epidemiologically predominant SARS- CoV-2 variants of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain). This will allow us to determine to which extent extra booster doses can or cannot induce more (binding) and/or better (neutralizing) antibodies to different variants as compared to peak responses achieved after previous vaccination doses and to study waning of these responses after winter periods.

Secondary objectives include studying the vaccine induced immunity in more detail. This includes the further characterization of the quality of the antibody response and the measurement of the cellular immune response, amongst others.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1050
        • Sciensano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a resident or member of staff in a nursing home and having participated in the previously organized PICOV-VAC study.
  • Being cognitively capable to give consent to participate in the study.
  • Being a healthy adults and having participated in the previous REDU-VAC study
  • Being a kidney transplant or dialysis patient and having participated in the previous NEPHRO-VAC study
  • Being a lung transplant patient and having participated in the previous LUNG-VAC study

Exclusion Criteria:

  • Having insufficient knowledge of the Dutch or French language..
  • Having a previous diagnosis of dementia and/or having a mini-mental state examination (MMSE) score < 18/30.
  • Having veins which are not accessible for simple peripheral blood puncture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Residents and staff from nursing homes from the previous PICOV-VAC study
Diagnostic test: Humoral immunity
determine binding and neutralizing antibody levels against the epidemiologically predominant SARS- CoV-2 variants of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain).
Experimental: Healthy adults from the previous REDU-VAC study
Diagnostic test: Humoral immunity
determine binding and neutralizing antibody levels against the epidemiologically predominant SARS- CoV-2 variants of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain).
Experimental: Kidney transplant and dialysis patients from the previous NEPHRO-VAC study
Diagnostic test: Humoral immunity
determine binding and neutralizing antibody levels against the epidemiologically predominant SARS- CoV-2 variants of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain).
Experimental: Lung transplant patients from the previous LUNG-VAC study
Diagnostic test: Humoral immunity
determine binding and neutralizing antibody levels against the epidemiologically predominant SARS- CoV-2 variants of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of SARS-CoV-2 binding and neutralizing antibodies
Time Frame: Three times a year, during two years
change in the concentration of binding and neutralizing antibodies against the epidemiologically predominant SARS-CoV-2 variant of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain)
Three times a year, during two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maturation of specific antibody affinity to SARS-CoV-2
Time Frame: Three times a year, during two years
change in SARS-CoV-2 specific antibody affinity maturation
Three times a year, during two years
Levels of mucosal antibodies to SARS-CoV-2
Time Frame: Three times a year, during two years
change of the mucosal antibodies to SARS-CoV-2
Three times a year, during two years
Frequencies of T and B cell to SARS-CoV-2
Time Frame: Three times a year, during two years
change of SARS-CoV-2 specific cellular immunity
Three times a year, during two years
Levels of non-neutralizing functions of antibodies to SARS-CoV-2
Time Frame: Three times a year, during two years
change of levels the non-neutralizing functions of antibodies
Three times a year, during two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Goossens

Collaborators

Institute of Tropical Medicine
Erasme University Hospital
Université Libre de Bruxelles
Mensura EDPB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2022/474
  • 2022-002531-56 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study is part of the BelCoVac consortium. The memorandum of understanding describes the conditions of data sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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