Clinical trial NCT05667597: Sars-COV-2 (COVID-19) Immunity in immunoCOmpromised Populations
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: SARS CoV 2 Infection
COVID-19
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: Université Libre de Bruxelles
name: Institute of Tropical Medicine
name: Mensura EDPB
name: Erasme University Hospital
First posted: 2022-12-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the intervention is the blood sampling
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of SARS-CoV-2 binding and neutralizing antibodies
timeFrame: Three times a year, during two years
Secondary outcomes:
measure: Maturation of specific antibody affinity to SARS-CoV-2
timeFrame: Three times a year, during two years
measure: Levels of mucosal antibodies to SARS-CoV-2
timeFrame: Three times a year, during two years
measure: Frequencies of T and B cell to SARS-CoV-2
timeFrame: Three times a year, during two years
measure: Levels of non-neutralizing functions of antibodies to SARS-CoV-2
timeFrame: Three times a year, during two years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sciensano
Study officials:
References:
citation: 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 protocol description and presentation of preliminary findings on symptoms. Arch Public Health. 2021 Nov 11;79(1):195. doi: 10.1186/s13690-021-00715-z.
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, Arien KK, Desombere I, Marchant A. Poor Antibody Response to BioNTech/Pfizer Coronavirus Disease 2019 Vaccination in Severe Acute Respiratory Syndrome Coronavirus 2-Naive Residents of Nursing Homes. Clin Infect Dis. 2022 Aug 24;75(1):e695-e704. doi: 10.1093/cid/ciab998.
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 Oct 1. No abstract available.
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. Safety and immunogenicity of a reduced dose of the BNT162b2 mRNA COVID-19 vaccine (REDU-VAC): A single blind, randomized, non-inferiority trial. PLOS Glob Public Health. 2022 Dec 20;2(12):e0001308. doi: 10.1371/journal.pgph.0001308. eCollection 2022.