This trial aims to measure the humoral and adaptive immune response in patients with cancer diagnosis undergoing mRNA vaccination against SARS-CoV-2 and assess its efficacy in preventing COVID-19.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
152
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Institut Jules Bordet
Anderlecht, Belgium
CHU UCL Namur Sainte-Elisabeth
Namur, Belgium
Humoral immune response against SARS-CoV-2 after the last dose of a mRNA anti-SARS-CoV-2 vaccine (Baseline assessment)
Rate of humoral immune response against SARS-CoV-2 between 3 and 12 months after the last dose (before ICF signature) of a mRNA anti-SARS-CoV-2 vaccine (baseline assessment)
Time frame: 3 to 12 months after the last dose
Humoral immune response against SARS-COV-2
Duration of humoral immune response against SARS-COV-2 based on the final study assessment, namely at 6 months (+ /- 4 weeks) after the baseline assessment or at 6 months (+ 4 weeks/- 8 weeks) after the first booster dose after ICF signature, if a booster dose of the vaccine is administered during the study per local / national health policy guidelines.
Time frame: at 6 months (+/- 4 weeks) after the baseline assessment or at 6 months (+ 4 weeks/- 8 weeks) after the first booster after ICF signature, if a booster dose of the vaccine is administered during the study per local / national health policy guidelines.
Humoral immune response against SARS-COV-2 by cohort
Rate of humoral immune response against SARS-COV-2 by cohort
Time frame: 3 to 12 months after the last dose before ICF signature; and 6 months (+/- 4 wks) after baseline assessment or 6 months (+ 4 wks/-8 wks) after the first booster after ICF signature if a booster dose is administered during the study
Rate of asymptomatic subjects with SARS-CoV-2 positive test during the study
Rate of asymptomatic subjects with SARS-CoV-2 positive test, confirmed COVID-19 or severe COVID-19 infection with onset at least 14 days after the last dose before ICF signature in subjects who had been without serologic or virological evidence of SARS-CoV-2 infection up to 14 days after the last dose before ICF signature.
Time frame: Retrospectively collected at each visit: at baseline assessment, pre-boosting (within 2 wks before 1st booster dose after ICF signature), post-boosting (2 wks after this booster); and 6 months after this booster OR after baseline assessment if no booster
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Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Safety of booster dose(s) of mRNA anti-SARS-CoV-2 vaccine received after ICF signature
Frequency, duration and severity of adverse reactions reported according to NCI Common Terminology Criteria for Adverse Events signature (CTCAE) Version 5.0, if booster dose(s) of the vaccine are administered during the study per local / national health policy guidelines.
Time frame: During the 30 days following the administration of the booster received during the study period (if any)