Overview
Sponsor-declared trial summary
Healthy persons and immunocompromised patients (nursing home residents, dialysis patients and kidney- and lung transplant patients) from age 18 till age 105
To assess the level of binding and neutralizing antibodies against the epidemiologically predominant SARS-CoV-2 variant of concern (VOC) three times a year
Key facts
- Sponsor
- Sciensano
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Decision date (initial)
- 2024-11-25
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518098-33-01
- EudraCT number
- 2022-002531-56
- ClinicalTrials.gov
- NCT05667597
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To assess the level of binding and neutralizing antibodies against the epidemiologically predominant SARS-CoV-2 variant of concern (VOC) three times a year
Secondary objectives 1
- 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 and MedDRA coding
Healthy persons and immunocompromised patients (nursing home residents, dialysis patients and kidney- and lung transplant patients) from age 18 till age 105
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518098-33-00 | LONGITUDINAL FOLLOW-UP OF SARS-COV-2 IMMUNITY IN IMMUNOCOMPROMISED POPULATIONS IN BELGIUM (COVICO) A non-commercial multicenter academic prospective cohort study during 2023-2026 | Sciensano |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Having participated in the previously organized PICOV-VAC, REDUVAC, Lung-VAC or Nephro-VAC cohorts
Exclusion criteria 2
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess the level of binding and neutralizing antibodies against the epidemiologically predominant SARS-CoV-2 variant of concern (VOC) three times a year
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Comirnaty JN.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
PRD11459645 · Product
- Active substance
- Bretovameran
- Substance synonyms
- 5'-capped mRNA encoding SARS-CoV-2, Omicron variant JN.1, spike protein
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 30 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/028
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
PRD10813392 · Product
- Active substance
- Raxtozinameran
- Substance synonyms
- 5'-capped mRNA encoding SARS-CoV-2, Omicron variant XBB.1.5, Spike protein, pre-fusion stabilised (K981P and V982P)
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 30 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/020
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sciensano
- Sponsor organisation
- Sciensano
- Address
- Juliette Wytsmanstraat 14
- City
- Elsene
- Postcode
- 1050
- Country
- Belgium
Scientific contact point
- Organisation
- Sciensano
- Contact name
- Scientific collaborator
Public contact point
- Organisation
- Sciensano
- Contact name
- Scientific collaborator
Locations
1 EU/EEA country · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 360 | 14 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518098-33-01 | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | L1_addendum ICF Dutch version | 1.2 |
| Recruitment arrangements (for publication) | L1_addendum ICF FR version | 1.2 |
| Subject information and informed consent form (for publication) | L1_addendum ICF Dutch version | 1 |
| Subject information and informed consent form (for publication) | L1_addendum ICF FR version | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Dutch version | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF FR version | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Comirnaty Omicron JN1 30 micrograms | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Comirnaty Omicron XB1 5 30 micrograms | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2024-518098-33-01 | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-18 | Belgium | Acceptable 2024-11-25
|
2024-11-25 |