| Trial registration number
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EUCTR2021-000300-38-BE |
Full text link
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000300-38/BE
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First author
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Antwerp University Hospital - data manager
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Contact
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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lise.verbruggen@uza.be
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Registration date
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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2021-01-25
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Recruitment status
Last imported at : Jan. 9, 2025, 8:07 a.m.
Source : EU Clinical Trials Register
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Completed
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Study design
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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nonRCT
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Allocation
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Non-randomized
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Design
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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single-center
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Study aim
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Prevention
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Inclusion criteria
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Age of 18 years or older
Patients should meet one of the cohort criteria
Life expectancy > 12 months
Ability to provide informed consent
ADDENDUM extra booster shot
Former participant of the B-VOICE study
Vaccinated with priming and boosting BNT162b2 vaccine
Ability to provide informed consent
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Exclusion criteria
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
|
Women who are pregnant or breastfeeding
Immune deficiency not related to cancer or cancer treatment
Systemic treatment with immune suppressive medication, including chronic steroid use of >10 mg prednisone or equivalent
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Number of arms
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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1
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Funding
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Antwerp University Hospital
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Inclusion age min
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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100
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Countries
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Belgium
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Type of patients
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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High risk patients
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Severity scale
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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N/A
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Total sample size
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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200
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primary outcome
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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neutralizing antibody titers against the SARS-CoV-2 spike protein and nucleocapsid protein on day 28 after second vaccination in patients receiving active cancer treatment.
ADDENDUM extra booster shot
The first co-primary endpoint is the difference in SARS-CoV-2 IgG levels, before and 28 days after
administration of a third dose of the COVID-19 mRNA BNT162b2 vaccine upon previous receipt of 2 doses
of this vaccine.
The second co-primary endpoint is the difference in SARS-CoV-2 IgG levels, before and 28 days after
administration of a fourth dose of the COVID-19 mRNA BNT162b2 vaccine upon previous receipt of 3 doses
of this vaccine.
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Notes
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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nan
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Phase
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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