COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2

Jules Bordet Institute2 sites in 1 country152 target enrollmentDecember 1, 2021

ConditionsCancer

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cancer
Sponsor: Jules Bordet Institute
Enrollment: 152
Locations: 2
Primary Endpoint: Humoral immune response against SARS-CoV-2 after the last dose of a mRNA anti-SARS-CoV-2 vaccine (Baseline assessment)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2021

End Date

January 8, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jules Bordet Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old
•ECOG performance status ≤ 2
•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 in 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.
•Life expectancy \> 6 months
•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.
•Urine/serum pregnancy test negative for all female subjects of childbearing potential within 7 days prior to subject enrolment.
•Signed Informed Consent form (ICF) obtained prior to any study related procedure
•Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.

Exclusion Criteria

•Known pregnant and/or lactating women.
•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.
•Subjects with active diagnosis of acute leukaemia.
•Subjects treated with bone marrow transplant \< 90 days before received vaccination against SARS-CoV-
•Subjects with a known history of HIV infection.
•COVID-19 infection in the last 28 days prior to subject enrolment.
•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.
•Subjects who, for any reason, did not receive the 2nd dose of the anti-SARS-CoV-2 mRNA vaccine.
•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 from protocol version 3.0 and subsequent versions.
•Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform.

Outcomes

Primary Outcomes

Humoral immune response against SARS-CoV-2 after the last dose of a mRNA anti-SARS-CoV-2 vaccine (Baseline assessment)

Time Frame: 3 to 12 months after the last dose

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)

Secondary Outcomes

Humoral immune response against SARS-COV-2(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(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)
Safety of booster dose(s) of mRNA anti-SARS-CoV-2 vaccine received after ICF signature(During the 30 days following the administration of the booster received during the study period (if any))
Rate of asymptomatic subjects with SARS-CoV-2 positive test during the study(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)