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

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ClinicalTrials.gov Identifier: NCT05075538
Recruitment Status : Not yet recruiting
First Posted : October 12, 2021
Last Update Posted : November 15, 2021
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Jules Bordet Institute

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 disease Intervention/treatment Phase
Cancer Biological: Spikevax Biological: Comirnaty Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2024

Intervention Details:
  • Biological: Spikevax
    Third dose as per national guidelines
  • Biological: Comirnaty
    Third dose as per national guidelines


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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075538


Contacts
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Contact: Evandro DE AZAMBUJA, MD PhD +3225413662 evandro.azambuja@bordet.be
Contact: Tabatha Delsaute +3225413662 tabatha.delsaute@bordet.be

Locations
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Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Contact: Angela Loizidou, MD       angela.loizidou@bordet.be   
Principal Investigator: Angela Loizidou, MD         
Sponsors and Collaborators
Jules Bordet Institute
Roche Pharma AG
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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT05075538    
Other Study ID Numbers: IJB-COVID-001
2021-003710-39 ( EudraCT Number )
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: October 2021

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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:
immunity
mRNA
vaccination
SARS-CoV-2
COVID-19
COVID19
Spikevax
Comirnaty
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases