Clinical trial • Phase IV • Immunology|Infectious Disease

raxtozinameran for SARS-CoV-2 infection / COVID-19 immunity

Phase IV trial of raxtozinameran for SARS-CoV-2 infection / COVID-19 immunity. None/Not specified-controlled. 360 participants.

Overview

Trial Therapeutic Area
Immunology|Infectious Disease
Trial Disease
SARS-CoV-2 infection / COVID-19 immunity
Trial Stage
Phase IV
Drug Modality
mRNA

Key dates

Initial CTIS Submission Date
18-11-2024
First CTIS Authorization Date
25-11-2024

Trial design

None/Not specified-controlled Phase IV trial across 14 sites in Belgium.

Comparator
None/Not specified
Target Sample Size
360

Eligibility

Recruits 360 isVulnerablePopulationSelected: false. Study population restricted to adults (from age 18 to 105). Informed consent documents (subject information and ICF) are provided (Dutch and French versions and addenda). No assent procedures or special consent for minors described..

Vulnerable Population
isVulnerablePopulationSelected: false. Study population restricted to adults (from age 18 to 105). Informed consent documents (subject information and ICF) are provided (Dutch and French versions and addenda). No assent procedures or special consent for minors described.

Inclusion criteria

  • {"criterion_text":"- Having participated in the previously organized PICOV-VAC, REDUVAC, Lung-VAC or Nephro-VAC cohorts"}

Exclusion criteria

  • {"criterion_text":"- Having a previous diagnosis of dementia and/or having a mini-mental state examination (MMSE) score < 18/30.\n- Having veins which are not accessible for simple peripheral blood puncture."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To assess the level of binding and neutralizing antibodies against the epidemiologically predominant SARS-CoV-2 variant of concern (VOC) three times a year","definition_or_measurement_approach":"Assessment of the level of binding and neutralizing antibodies against the epidemiologically predominant SARS-CoV-2 VOC measured three times a year."}

Secondary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Further characterization of antibody quality and measurement of cellular immune response as part of detailed immunological analyses (as stated)."}

Recruitment

Planned Sample Size
360
Recruitment Window Months
47
Consent Approach
Informed consent obtained from each participant using subject information and informed consent form documents. Dutch and French versions and addenda of the ICF are available. Participants are adults (18+); no assent procedures described.

Methods

  • Recruitment from previously organized cohorts: participants who participated in the PICOV-VAC, REDUVAC, Lung-VAC or Nephro-VAC cohorts (target audience: previous cohort participants; country: Belgium).

Geography

Total Number Of Sites
14
Total Number Of Participants
360

Belgium

Earliest CTIS Part Ii Submission Date
20-11-2024
Latest Decision Or Authorization Date
25-11-2024
Processing Time Days
5
Number Of Sites
14
Number Of Participants
360

Sites

Site Name
Hospital Erasme
Department Name
Pneumologie
Contact Person Name
Isabelle Etienne
Site Name
Hospital Erasme
Department Name
Nephrology
Contact Person Name
Alain Lemoine
Contact Person Email
alain.lemoine@hubruxelles.be
Site Name
Mensura EDPB - Gosselies
Department Name
Gosselies
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Sint Anna
Department Name
Sint Anna
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Sciensano
Department Name
Infectious diseases in humans
Contact Person Name
Maria Goosent
Contact Person Email
maria.goossens@sciensano.be
Site Name
Mensura EDPB - Hasselt
Department Name
Hasselt
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Zonnetij
Department Name
Zonnetij
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Betlehem
Department Name
Betlehem
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Brussel
Department Name
Brussel
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Damiaan
Department Name
Damiaan
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Residentie ter Kameren
Department Name
Residentie ter Kameren
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura - Zwijnaarde
Department Name
Zwijnaarde
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Antwerpen
Department Name
Antwerpen
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be
Site Name
Mensura EDPB - Zonnewende
Department Name
Zonnewende
Contact Person Name
Nele Van Loon
Contact Person Email
nele.vanloon@mensura.be

Sponsor

Primary sponsor

Full Name
Sciensano
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
Active Substance
raxtozinameran
Modality
mRNA
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/20/1528/020)
Starting Dose
30 µg
Dose Levels
30 µg
Maximum Dose
30 µg
Investigational Product Name
Comirnaty JN.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
Active Substance
bretovameran
Modality
mRNA
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/20/1528/028)
Starting Dose
30 µg
Dose Levels
30 µg
Maximum Dose
30 µg

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