I-SPARC: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2

Sponsor
Jules Bordet Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05075538
Collaborator
Roche Pharma AG (Industry)
525
Enrollment
1
Location
27
Anticipated Duration (Months)
19.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Spikevax
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
525 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Humoral immune response against SARS-CoV-2 after the second dose of a mRNA anti-SARS-CoV-2 vaccine (Baseline assessment) [6 months (+/- 4 weeks) after the second dose]

    Rate of humoral immune response against SARS-CoV-2 at 6 months (+/- 4 weeks) after the second dose of a mRNA anti-SARS-CoV-2 vaccine.

Secondary Outcome Measures

  1. Humoral immune response against SARS-COV-2 [at 6 months (+/- 4 weeks) after the baseline assessment or at 6 months (+/- 4 weeks) after the boost with the third dose if administered until 12 months (+/- 4 weeks) after the second dose per local / national health policy guidelines.]

    Rate of humoral immune response against SARS-COV-2 at 6 months (+/- 4 weeks) after the baseline assessment or at 6 months (+/- 4 weeks) after the boost with the 3rd dose if administered until 12 months (+/- 4 weeks) after the 2nd dose per local / national health policy guidelines.

  2. Rate of humoral immune response against SARS-COV-2, by underlying malignant disease [6 months (+/- 4 weeks) after the 2nd dose; and 6 months (+/- 4 weeks) after baseline assessment or 6 months (+/- 4 weeks) after the boost with the 3rd dose if administered until 12 months (+/- 4 weeks) after the 2nd dose per local / national health po]

    Rate of humoral immune response against SARS-COV-2, by underlying malignant disease

  3. Rate of humoral immune response against SARS-COV-2 by cohort [6 months (+/- 4 weeks) after the 2nd dose; and 6 months (+/- 4 weeks) after baseline assessment or 6 months (+/- 4 weeks) after the boost with the 3rd dose if administered until 12 months (+/- 4 weeks) after the 2nd dose per local / national health po]

    Rate of humoral immune response against SARS-COV-2 by cohort

  4. Rate of asymptomatic subjects with SARS-CoV-2 positive test during the study [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 2nd dose in subjects who had been without serologic or virological evidence of SARS-CoV-2 infection up to 14 days after the 2nd dose.

Other Outcome Measures

  1. Rate of humoral immune response against SARS-COV-2 before and after the third dose [within 2 weeks before 3rd dose and at 2 weeks after 3rd dose (+/- 3 days), if administered by until 12 months (+/- 4 weeks) after the 2nd dose per local/national health policy guidelines.]

    Rate of humoral immune response against SARS-COV-2 at pre- (within 2 weeks before 3rd dose) and post-boosting (at 2 weeks after 3rd dose, +/- 3 days) with the 3rd dose, if administered by until 12 months (+/- 4 weeks) after the 2nd dose per local/national health policy guidelines.

  2. Changes in the levels of circulating cytokines/chemokines and the balance or differentiation/activation status of lymphocyte subpopulations and their association with anti-SARS-CoV-2 antibodies [i) 6 months (+/- 4 weeks) after the 2nd dose; and ii) if a 3rd dose of the vaccine is administered until 12 months (+/- 4 weeks) after the 2nd dose per local / national health policy guidelines; at pre- (within 2 weeks before 3rd dose), post-boosting (at]

    Changes in the levels of circulating cytokines/chemokines and the balance or differentiation/activation status of lymphocyte subpopulations and their association with anti-SARS-CoV-2 antibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥ 18 years old

  • ECOG performance status ≤ 2

  • Must have histologically or cytologically confirmed cancer diagnosis (invasive solid tumour or haematological malignancy)

  • currently undergoing active systemic cancer treatment (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in non-metastatic setting or in metastatic setting (1st line therapy at the time of 1st dose of the anti-SARS-CoV-2 mRNA vaccine)

  • or currently undergoing follow-up after confirmed cancer complete remission without active cancer treatment for the last 12 months

  • Life expectancy > 6 months

  • Received 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.

  • Urine 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-2.

  • Subjects with a known history of HIV infection.

  • COVID-19 infection in the last 28 days before receiving first dose of vaccination against SARS-CoV-2 and up 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.

  • Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform.

  • Known prior severe hypersensitivity to anti-SARS-CoV-2 mRNA vaccines or any component in its formulations.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Institut Jules BordetBrusselsBelgium1000

Sponsors and Collaborators

  • Jules Bordet Institute
  • Roche Pharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT05075538
Other Study ID Numbers:
  • IJB-COVID-001
  • 2021-003710-39
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jules Bordet Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021