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

COVID-19 Clinical Trial

— COVICO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05667597
• Other study ID #: P2022/474
• Secondary ID: 2022-002531-56
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Sciensano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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).

Locations

Country	Name	City	State
Belgium	Sciensano	Brussels

Sponsors (5)

Lead Sponsor	Collaborator
Maria Goossens	Erasme University Hospital, Institute of Tropical Medicine, Mensura EDPB, Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Goossens ME, Neven KY, Pannus P, Barbezange C, Thomas I, Gucht SV, Dierick K, Schmickler MN, Verbrugghe M, Loon NV, Arien KK, Marchant A, Goriely S, Desombere I. The prior infection with SARS-CoV-2 study (PICOV) in nursing home residents and staff - study — View Citation

Kemlin D, Lemy A, Pannus P, Desombere I, Gemander N, Goossens ME, Marchant A, Le Moine A. Hybrid immunity to SARS-CoV-2 in kidney transplant recipients and hemodialysis patients. Am J Transplant. 2022 Mar;22(3):994-995. doi: 10.1111/ajt.16853. Epub 2021 O — View Citation

Pannus P, Depickere S, Kemlin D, Houben S, Neven KY, Heyndrickx L, Michiels J, Willems E, De Craeye S, Francotte A, Chaumont F, Olislagers V, Waegemans A, Verbrugghe M, Schmickler MN, Van Gucht S, Dierick K, Marchant A, Desombere I, Arien KK, Goossens ME. — View Citation

Pannus P, Neven KY, De Craeye S, Heyndrickx L, Vande Kerckhove S, Georges D, Michiels J, Francotte A, Van Den Bulcke M, Zrein M, Van Gucht S, Schmickler MN, Verbrugghe M, Matagne A, Thomas I, Dierick K, Weiner JA, Ackerman ME, Goriely S, Goossens ME, Arie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of SARS-CoV-2 binding and neutralizing antibodies	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	Maturation of specific antibody affinity to SARS-CoV-2	change in SARS-CoV-2 specific antibody affinity maturation	Three times a year, during two years
Secondary	Levels of mucosal antibodies to SARS-CoV-2	change of the mucosal antibodies to SARS-CoV-2	Three times a year, during two years
Secondary	Frequencies of T and B cell to SARS-CoV-2	change of SARS-CoV-2 specific cellular immunity	Three times a year, during two years
Secondary	Levels of non-neutralizing functions of antibodies to SARS-CoV-2	change of levels the non-neutralizing functions of antibodies	Three times a year, during two years