COVID-19: Immune response in patients with cancer undergoing mRNA vaccination against SARS-CoV-2. I-SPARC study - I-SPARC

INSTITUT JULES BORDET0 sites525 target enrollmentJanuary 24, 2022

Overview

No summary available.

Registry

who.int

Start Date

January 24, 2022

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

INSTITUT JULES BORDET

•Subjects must meet all of the following criteria in order to be eligible for this study:
•1\) Age \= 18 years old
•2\) ECOG performance status \= 2
•3\) Subjects with histologically or cytologically confirmed cancer diagnosis (invasive solid tumour or haematological malignancy)
•undergoing active systemic cancer treatment at the time of 1st dose of the anti\-SARS\-CoV\-2 mRNA vaccine (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in
•\- non\-metastatic setting or
•\- metastatic setting (only 1st line therapy )
•or undergoing follow\-up after confirmed cancer complete remission without active cancer treatment for the last 12 months at the time of 1st dose of the anti\-SARS\-CoV\-2 mRNA vaccine
•4\) Life expectancy \> 6 months
•5\) Subjects who received the 2nd dose of mRNA platform vaccination against SARS\-CoV\-2 as per local guidelines within 6 months (maximum until 6 months and 3 weeks) prior to registration.

•Subjects meeting one of the following criteria are not eligible for this study:
•1\) Known pregnant and/or lactating women.
•2\) Subject with a significant medical, neuro\-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study.
•3\) Subjects with active diagnosis of acute leukaemia.
•4\) Subjects treated with bone marrow transplant \< 90 days before received vaccination against SARS\-CoV\-2\.
•5\) Subjects with a known history of HIV infection.
•6\) COVID\-19 infection in the last 28 days before receiving first dose of vaccination against SARS\-CoV\-2 and up to subject enrolment.
•7\) Subjects receiving prolonged and/or high doses of systemic immunosuppressive therapies including corticosteroids during the last 28 days before receiving first dose of vaccination against SARS\-CoV\-2 and up to subject enrolment.8\) Subjects who, for any reason, did not receive the 2nd dose of the anti\-SARS\-CoV\-2 mRNA vaccine.
•9\) Subjects that received the 3rd dose of anti\-SARS\-CoV\-2 mRNA vaccine prior to study entry.
•10\) Subject that received any dose of non\-mRNA anti\-SARS\-CoV\-2 vaccine platform.