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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05075538
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : August 31, 2022
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
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Spikevax
    Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
  • Biological: Comirnaty
    Booster dose, if a booster dose is administered during the study per local / national health policy 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/ - 8 weeks) after the last dose ]
    Rate of humoral immune response against SARS-CoV-2 at 6 months (+ 4 weeks/ - 8 weeks) after the last dose (before ICF signature) of a mRNA anti-SARS-CoV-2 vaccine (baseline assessment)


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/- 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. ]
    Duration of humoral immune response against SARS-COV-2 based on the final study assessment, namely at 6 months (+ /- 4 weeks) after the baseline assessment or at 6 months (+ 4 weeks/- 8 weeks) after the first booster dose after ICF signature, if a booster dose of the vaccine is administered during the study per local / national health policy guidelines.

  2. Humoral immune response against SARS-COV-2 by cohort [ Time Frame: 6 months (+ 4 wks/- 8 wks) 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 ]
    Rate of humoral immune response against SARS-COV-2 by cohort

  3. Rate of asymptomatic subjects with SARS-CoV-2 positive test during the study [ Time Frame: 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 ]
    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 last dose before ICF signature in subjects who had been without serologic or virological evidence of SARS-CoV-2 infection up to 14 days after the last dose before ICF signature.

  4. Safety of booster dose(s) of mRNA anti-SARS-CoV-2 vaccine received after ICF signature [ Time Frame: During the 30 days following the administration of the booster received during the study period (if any) ]
    Frequency, duration and severity of adverse reactions reported according to NCI Common Terminology Criteria for Adverse Events signature (CTCAE) Version 5.0, if booster dose(s) of the vaccine are administered during the study per local / national health policy guidelines.


Other Outcome Measures:
  1. Rate of humoral immune response against SARS-COV-2 before and after the last dose [ Time Frame: within 2 weeks before the first booster after ICF signature, at 2 weeks +/- 3 days after the first booster after ICF signature) if a booster dose is administered during the study per local/national health policy guidelines ]
    Rate of humoral immune response against SARS-COV-2 at pre- (within 2 weeks before the first booster after ICF signature) and post-boosting (at 2 weeks +/- 3 days after the first booster after ICF signature) if a booster dose is administered during the study 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 wks/- 8wks) after the last dose before ICF signature; AND ii) in case of booster before ICF signature, 2 wks before the first booster, 2 wks after this booster, 6 months after this booster OR iii) 6 months after baseline assessment ]
    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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  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 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.
  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 within the last 6 months (maximum until 6 months and 4 weeks) prior to baseline assessment.
  6. Urine/serum pregnancy test negative for all female subjects of childbearing potential within 7 days prior to subject enrolment.
  7. Signed Informed Consent form (ICF) obtained prior to any study related procedure and obtained within 8 weeks prior to the baseline assessment
  8. 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:

  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 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 from protocol version 3.0 and subsequent versions.
  10. Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform.
  11. Subject with a known or suspected history of severe adverse reactions associated with a vaccine and/or with severe allergic reaction to vaccine components or anaphylaxis in the past.
  12. Subjects who planned to receive any other licensed vaccines for other indications within 28 days prior to the first booster dose after ICF signature or who are planning to receive any other vaccine up to 14 days after the first booster dose of the mRNA anti-SARS-CoV-2 vaccine after ICF signature (28 days for live attenuated vaccines). For influenza vaccination, a shorter interval or simultaneous administration is acceptable.
  13. Subjects who have planned to receive a booster dose after ICF signature but before the baseline assessment

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 Recruiting
Anderlecht, Belgium, 1070
Contact: Angela Loizidou, MD       angela.loizidou@bordet.be   
Contact: Vanessa Coubeaux    +32494246635    vanessa.coubeaux@bordet.be   
Principal Investigator: Angela Loizidou, MD         
CHU UCL Namur Sainte-Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Donatienne Taylor, MD       donatienne.taylor@chuuclnamur.uclouvain.be   
Contact: Monique Gilsoul    +3281720548    monique.gilsoul@chuuclnamur.uclouvain.be   
Principal Investigator: Donatienne Taylor, 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: August 31, 2022
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