SARS CoV 2 InfectionCOVICONCT05667597
Sars-COV-2 (COVID-19) Immunity in immunoCOmpromised Populations
A study testing Humoral immunity in people with SARS CoV 2 Infection and COVID-19, run by Maria Goossens at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, COVID-19
- What is being tested?
- Humoral immunity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- SARS CoV 2 Infection, COVID-19
- Being tested
- Humoral immunity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Residents and staff from nursing homes from the previous PICOV-VAC study | Experimental | Not described Receives: Diagnostic Test: Humoral immunity |
| Healthy adults from the previous REDU-VAC study | Experimental | Not described Receives: Diagnostic Test: Humoral immunity |
| Kidney transplant and dialysis patients from the previous NEPHRO-VAC study | Experimental | Not described Receives: Diagnostic Test: Humoral immunity |
| Lung transplant patients from the previous LUNG-VAC study | Experimental | Not described Receives: Diagnostic Test: Humoral immunity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three times a year, during two years
Secondary outcomes (4)
Maturation of specific antibody affinity to SARS-CoV-2
change in SARS-CoV-2 specific antibody affinity maturation
Measured: Three times a year, during two years
Levels of mucosal antibodies to SARS-CoV-2
change of the mucosal antibodies to SARS-CoV-2
Measured: Three times a year, during two years
Frequencies of T and B cell to SARS-CoV-2
change of SARS-CoV-2 specific cellular immunity
Measured: Three times a year, during two years
Levels of non-neutralizing functions of antibodies to SARS-CoV-2
change of levels the non-neutralizing functions of antibodies
Measured: Three times a year, during two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start23 Jan 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- the intervention is the blood sampling
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Goossens
- Sponsor type
- Other government
- Collaborators
- Université Libre de Bruxelles, Institute of Tropical Medicine, Mensura EDPB, Erasme University Hospital
- Responsible party
- Sponsor-investigator, Maria Goossens, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667597
- Sponsor's protocol ID
- P2022/474
- Other IDs
- 2022-002531-56
- Acronym
- COVICO
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is part of the BelCoVac consortium. The memorandum of understanding describes the conditions of data sharing.
Publications
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.
PubMed 34763723Pannus 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.
PubMed 34864935Kemlin 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.
PubMed 34554629Pannus 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.
PubMed 36962838
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05667597
- Acronym / sponsor ID
- COVICO / P2022/474
- Conditions
- SARS CoV 2 Infection, COVID-19
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Maria GoossensOther government
- Collaborators
- Université Libre de Bruxelles, Institute of Tropical Medicine, Mensura EDPB, Erasme University Hospital
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- the intervention is the blood sampling
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humoral immunitydetermine 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). | Diagnostic test | Healthy adults from the previous REDU-VAC study, Kidney transplant and dialysis patients from the previous NEPHRO-VAC study, Lung transplant patients from the previous LUNG-VAC study, Residents and staff from nursing homes from the previous PICOV-VAC study |
Primary outcome
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)
4 secondary outcomes
Maturation of specific antibody affinity to SARS-CoV-2
Time frame: Three times a year, during two years
Levels of mucosal antibodies to SARS-CoV-2
Time frame: 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
Levels of non-neutralizing functions of antibodies to SARS-CoV-2
Time frame: Three times a year, during two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Results publication: PubMed 34763723Goossens 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.
- Results publication: PubMed 34864935Pannus 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.
- Results publication: PubMed 34554629Kemlin 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.
- Results publication: PubMed 36962838Pannus 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.
- Individual participant dataSharing planned: Yes. This study is part of the BelCoVac consortium. The memorandum of understanding describes the conditions of data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humoral immunity in people with SARS CoV 2 Infection and COVID-19, run by Maria Goossens at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of SARS-CoV-2 binding and neutralizing antibodies (time frame: Three times a year, during two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05667597, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.