Vaccination against cOvid-19 In CancER patients under active treatment in Belgium

Phase 1

Active, not recruiting

• Conditions: Therapeutic area: Body processes [G] - Immune system processes [G12]; Onco-hematological patients

• Registration Number: EUCTR2021-000300-38-BE
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-25
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified