CancerREAL-VNCT05033158
The Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population.
A study testing Blood sampling in people with Cancer, run by University Hospital, Antwerp at 8 sites in Belgium.
Trial summary
This study investigates the immune response in the cancer population in Belgium being vaccinated with an approved vaccine types being authorized for use in Belgium. This question needs to be answered to make sure that this vulnerable population is properly protected against possible SARS-CoV-2 infection and that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood sampling
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 8 sitesBelgium
- Study dates
- 1 Apr 2021to 13 Jun 2023
- Phase
- Interventional
- 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 of 18 years or older
- Oncological or hematological malignancy or history of it
- Life expectancy > 3 months
- Ability to provide informed consent
Who cannot join
- Women who are pregnant or breastfeeding
- Immune deficiency not related to cancer or cancer treatment
- Allergy (multiple); to be determined by physician
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
AZ Klina
Brasschaat
AZ Sint Jan
Bruges
UZ Brussel
Brussels
University Hospital Antwerp
Edegem, Antwerp
AZ Sint Lucas
Ghent
UZ Gent
Ghent
AZ Groeninge
Kortrijk
AZ Nikolaas
Sint-Niklaas
About this study
Official title: Investigation to Reveal the Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population: COVID-19 Protection and Vaccine Safety (REAL-V)
This study investigates the immune response in the cancer population in Belgium being vaccinated with an approved vaccine types being authorized for use in Belgium. This question needs to be answered to make sure that this vulnerable population is properly protected against possible SARS-CoV-2 infection and that vaccine administration is safe.
Read the detailed description
Rationale: Patients with cancer have an increased risk of adverse outcome of COVID-19 and should be at high prioritisation for vaccination against SARS-CoV-2. The COVID-19 vaccine trials have not included cancer patients as such, the efficacy and duration of immunity in patients with cancer are still unknown. Keeping in mind that cancer patients are often immunocompromised, the immune response upon vaccination needs further investigation.
The REAL-V is a prospective, multicenter cohort study. The humoral immunity response based on anti-SARS-CoV-2 IgG antibodies upon COVID-19 vaccination will be investigated in blood samples taken 4 months, 6 months and 12 months after (first) vaccine administration. Potential factors that affect immunity, will be recorded, such as type and stage of cancer, anti-cancer treatment, concomitant medication,..To investigate the safety of different COVID-19 vaccines, incidence and severity of systemic adverse events will be reported using an App based system answering questionnaires about specific vaccine related complaints.
- Conditions
- Cancer
- Being tested
- Blood sampling
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling before and after COVID-19 vaccination
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Other | Level of antibodies against SARS-CoV-2 will be measured in these patients Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response
The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies 4 months after (first) vaccine administration. Antibody titers to the full Spike, S1, S2, RBD (receptor binding domain) and N (nucleocapsid) protein of SARS-CoV-2 will be measured quantitatively. For this measurement a multiplex SARS-CoV-2 immunoassay will be used.
Measured: 4 months
Secondary outcomes (4)
Duration of the immune response
To study the evolution and duration of the immune response after vaccination: using serological assays to analyze anti-RBD IgG titers 6 months after (first) vaccine administration.
Measured: 6 months
Neutralizing capacity
To analyze the titer of neutralizing antibodies both 4 and 6 months after (first) vaccine administration
Measured: 6 months
Efficacy of the immune response
This will be assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARSCoV-2 infection within a time-frame of 12 months after the start of the study.
Measured: 12 months
Vaccine safety
Safety will be reported in terms of incidence and severity of systemic adverse events (AEs) during a continuous App based reporting system or using a questionnaire 3 days after vaccine administration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2022
- Study completion13 Jun 2023
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.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- KomOpTegenKanker (non-profit organization)
- Responsible party
- Sponsor
- Investigators
- Marc Peeters, Prof. MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033158
- Sponsor's protocol ID
- 001752
- Acronym
- REAL-V
- Status last verified
- Jun 2023
- First submitted
- 2 Apr 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation to Reveal the Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population: COVID-19 Protection and Vaccine Safety (REAL-V)
- ClinicalTrials.gov ID
- NCT05033158
- Acronym / sponsor ID
- REAL-V / 001752
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- KomOpTegenKanker (non-profit organization)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 2 Sep 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 study investigates the immune response in the cancer population in Belgium being vaccinated with an approved vaccine types being authorized for use in Belgium. This question needs to be answered to make sure that this vulnerable population is properly protected against possible SARS-CoV-2 infection and that vaccine administration is safe.
Detailed description
Rationale: Patients with cancer have an increased risk of adverse outcome of COVID-19 and should be at high prioritisation for vaccination against SARS-CoV-2. The COVID-19 vaccine trials have not included cancer patients as such, the efficacy and duration of immunity in patients with cancer are still unknown. Keeping in mind that cancer patients are often immunocompromised, the immune response upon vaccination needs further investigation.
The REAL-V is a prospective, multicenter cohort study. The humoral immunity response based on anti-SARS-CoV-2 IgG antibodies upon COVID-19 vaccination will be investigated in blood samples taken 4 months, 6 months and 12 months after (first) vaccine administration. Potential factors that affect immunity, will be recorded, such as type and stage of cancer, anti-cancer treatment, concomitant medication,..To investigate the safety of different COVID-19 vaccines, incidence and severity of systemic adverse events will be reported using an App based system answering questionnaires about specific vaccine related complaints.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Other | Other: Blood samplingLevel of antibodies against SARS-CoV-2 will be measured in these patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years or older
- Oncological or hematological malignancy or history of it
- Life expectancy > 3 months
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding
- Immune deficiency not related to cancer or cancer treatment
- Allergy (multiple); to be determined by physician
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 |
|---|---|---|
| Blood samplingBlood sampling before and after COVID-19 vaccination | Other | Cancer patients |
Primary outcome
Immune response
Time frame: 4 months
The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies 4 months after (first) vaccine administration. Antibody titers to the full Spike, S1, S2, RBD (receptor binding domain) and N (nucleocapsid) protein of SARS-CoV-2 will be measured quantitatively. For this measurement a multiplex SARS-CoV-2 immunoassay will be used.
4 secondary outcomes
Duration of the immune response
Time frame: 6 months
Neutralizing capacity
Time frame: 6 months
Efficacy of the immune response
Time frame: 12 months
Vaccine safety
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Marc Peeters, Prof. MD principal investigator
University Hospital, Antwerp
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Cancer, run by University Hospital, Antwerp at 8 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immune response (time frame: 4 months). 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 15 Jun 2023.