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

INSTITUT JULES BORDET0 sites440 target enrollmentOctober 7, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 7, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

INSTITUT JULES BORDET

•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 the last dose (before ICF signature) of the anti\-SARS\-CoV\-2 mRNA vaccine (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in
•\-non\-metastatic/curative setting or
•\-metastatic/palliative setting
•or undergoing follow\-up after confirmed cancer complete remission without active cancer treatment for the last 12 months at the time of the last dose (before ICF signature) of the anti\-SARS\-CoV\-2 mRNA vaccine.
•4\)Life expectancy \> 6 months
•5\)Subjects who received at least 2 doses of mRNA platform vaccination against SARS\-CoV\-2 as per local guidelines, with the last dose being given between 3 and 12 months prior to baseline assessment.
•6\)Urine/serum pregnancy test negative for all female subjects of childbearing potential within 7 days prior to subject enrolment.

•1\)Known pregnant and/or lactating women.
•2\)Subject with a known 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 the last dose of vaccination against SARS\-CoV\-2 received before ICF signature.
•5\)Subjects with a known history of HIV infection.
•6\)COVID\-19 infection in the last 28 days prior 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. Exclusion criterion number 9 is only applicable for previous versions of the protocol and is not applicable for protocol version 3\.0 and subsequent versions.
•10\)Subject that received any dose of non\-mRNA anti\-SARS\-CoV\-2 vaccine platform.