CancerPhase 4I-SPARCNCT05075538
COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2
A Phase 4 study testing Spikevax, Comirnaty and Spikevax bivalent Original/Omicron BA.1 in people with Cancer, run by Jules Bordet Institute at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Spikevax, Comirnaty and Spikevax bivalent Original/Omicron BA.1
- How many people
- 152 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Dec 2021to 8 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 prior to subject enrolment.
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- 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.
- 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.
- 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.
- Subjects who have planned to receive a booster dose after ICF signature but before the baseline assessment
- Subjects who received COVID-19 pre-exposure prophylactic monoclonal antibodies or who have been treated with anti-SARS-CoV-2 monoclonal antibodies or COVID-19 convalescent plasma during the last 6 months before ICF signature.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Institut Jules Bordet
Anderlecht, 1070
CHU UCL Namur Sainte-Elisabeth
Namur, 5000
About this study
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.
- Conditions
- Cancer
- Being tested
- Spikevax, Comirnaty, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Comirnaty Original/Omicron BA.1
- Keywords
- immunity, mRNA, vaccination, SARS-CoV-2, COVID-19, COVID19, Spikevax, Comirnaty, Omicron
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpikevaxBiological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
ComirnatyBiological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Spikevax bivalent Original/Omicron BA.1Biological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Spikevax bivalent Original/Omicron BA.4-5Biological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Comirnaty Original/Omicron BA.1Biological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Comirnaty Original/Omicron BA.4-5Biological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Comirnaty Omicron XBB.1.5Biological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
Spikevax Omicron XBB.1.5Biological
Booster dose, if a booster dose is administered during the study per local / national health policy guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immune response against SARS-CoV-2 after the last dose of a mRNA anti-SARS-CoV-2 vaccine (Baseline assessment)
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)
Measured: 3 to 12 months after the last dose
Secondary outcomes (4)
Humoral immune response against SARS-COV-2
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.
Measured: 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
Rate of humoral immune response against SARS-COV-2 by cohort
Measured: 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
Rate of asymptomatic subjects with SARS-CoV-2 positive test 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 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.
Measured: 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
Safety of booster dose(s) of mRNA anti-SARS-CoV-2 vaccine received after ICF signature
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.
Measured: During the 30 days following the administration of the booster received during the study period (if any)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Dec 2021
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Why it stopped: The population as defined by the inclusion/exclusion criteria and the study logistics were leading to a poor recruitment over the past years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075538
- Sponsor's protocol ID
- IJB-COVID-001
- Other IDs
- 2021-003710-39
- Acronym
- I-SPARC
- Status last verified
- Feb 2023
- First submitted
- 7 Oct 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05075538
- Acronym / sponsor ID
- I-SPARC / IJB-COVID-001
- Conditions
- Cancer
- Keywords
- immunity, mRNA, vaccination, SARS-CoV-2, COVID-19, COVID19, Spikevax, Comirnaty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The population as defined by the inclusion/exclusion criteria and the study logistics were leading to a poor recruitment over the past years.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old
- ECOG performance status ≤ 2
- Subjects with histologically or cytologically confirmed cancer diagnosis (invasive solid tumour or haematological malignancy)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpikevaxBooster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
| ComirnatyBooster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
| Spikevax bivalent Original/Omicron BA.1Booster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
| Spikevax bivalent Original/Omicron BA.4-5Booster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
| Comirnaty Original/Omicron BA.1Booster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
| Comirnaty Original/Omicron BA.4-5Booster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
| Comirnaty Omicron XBB.1.5Booster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
| Spikevax Omicron XBB.1.5Booster dose, if a booster dose is administered during the study per local / national health policy guidelines. | Biological | – |
Primary outcome
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)
4 secondary outcomes
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.
Humoral immune response against SARS-COV-2 by cohort
Time frame: 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
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
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)
Results and safety
The study was stopped early (reason given: The population as defined by the inclusion/exclusion criteria and the study logistics were leading to a poor recruitment over the past years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spikevax, Comirnaty and Spikevax bivalent Original/Omicron BA.1 in people with Cancer, run by Jules Bordet Institute at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The population as defined by the inclusion/exclusion criteria and the study logistics were leading to a poor recruitment over the past years.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.