NCT05667597

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

July 4, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

3.8 years

First QC Date

July 4, 2022

Last Update Submit

June 5, 2025

Conditions

SARS CoV 2 InfectionCOVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Maturation of specific antibody affinity to SARS-CoV-2

    Three times a year, during two years

  • Levels of mucosal antibodies to SARS-CoV-2

    Three times a year, during two years

  • Frequencies of T and B cell to SARS-CoV-2

    Three times a year, during two years

  • Levels of non-neutralizing functions of antibodies to SARS-CoV-2

    Three times a year, during two years

Study Arms (4)

Residents and staff from nursing homes from the previous PICOV-VAC study

EXPERIMENTAL
Diagnostic Test: Humoral immunity

Healthy adults from the previous REDU-VAC study

EXPERIMENTAL
Diagnostic Test: Humoral immunity

Kidney transplant and dialysis patients from the previous NEPHRO-VAC study

EXPERIMENTAL
Diagnostic Test: Humoral immunity

Lung transplant patients from the previous LUNG-VAC study

EXPERIMENTAL
Diagnostic Test: Humoral immunity

Interventions

Humoral immunityDIAGNOSTIC_TEST

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).

Healthy adults from the previous REDU-VAC studyKidney transplant and dialysis patients from the previous NEPHRO-VAC studyLung transplant patients from the previous LUNG-VAC studyResidents and staff from nursing homes from the previous PICOV-VAC study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sciensano

Brussels, 1050, Belgium

Location

Related 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 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.

    PMID: 34763723RESULT

  • 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.

    PMID: 34864935RESULT

  • 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.

    PMID: 34554629RESULT

  • 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.

    PMID: 36962838RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Immunity, Humoral

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adaptive ImmunityImmunityImmune System Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: the intervention is the blood sampling
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinator observational trial unit

Study Record Dates

First Submitted

July 4, 2022

First Posted

December 28, 2022

Study Start

January 23, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF

Locations

BE(1)