- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04745377
Responses to COVID-19 Vaccination in Patients With Cancer (ReCOVer)
Mapping the Responses to COVID-19 Vaccination in Patients With Cancer - the ReCOVer Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is well recognised that patients with cancer are at an increased risk of severe COVID-19 disease and should be at high prioritisation for vaccination against SARS-CoV-2. In Greece the vaccination of healthcare workers has been initiated in January 2021, elderly citizens as well and for cancer patients of all ages will be initiated early February 2021. There are very little available data on the efficacy of immunisation with vaccines overall in cancer patients, with most existing data involving the influenza vaccine. The covid-19 vaccine trials have not included cancer patients, therefore, the efficacy and duration of immunity in patients with cancer are still unknown. Those patients are often immunocompromised due to their disease or the side-effects of their treatment.
Based on the above this study was designed to prospectively record and monitor patients with cancer after covid-19 vaccination. The study will record and measure clinical outcomes, such as possible infection from covid-19 despite vaccination, severity and mortality, but also possible side effects post vaccination. Within the study serological responses (IgG antibody titers) will also be monitored in three timepoints (prior to vaccination, one month and three months after completion of the two doses of vaccination). Potential factors that affect immunity, will be recorded, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Attica
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Athens, Attica, Greece, 18547
- Metropolitan Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination.
Also a group of healthy volunteers from the hospital personnel that have been vaccinated within the National Program of Vaccination and signed informed consent for 3 measurements of antibody titers in serum, at the timepoints described aboved.
Description
Inclusion Criteria:
- Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination
- patients must sign informed consent for their data monitoring and also for serum antibody titers to covid-19 vaccination measured in three timepoints, prior to 1st dose and 1 and 3 months post completion of two doses
Exclusion Criteria:
- patients with haematological malignancies are excluded
- patients with prior diagnosis of cancer and now on follow-up without active disease are excluded
- patients on adjuvant hormonal therapy are excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control Group
Healthy volunteers from hospital personnel vaccinated for covid-19, who sign informed consent for recording of outcomes and monitor of antibody titers in 3 timepoints
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IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus
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Cancer patients
Cancer patients with solid tumours, with active disease and/or undergoing active systemic treatment, who will be vaccinated for covid-19
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IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcome post vaccination
Time Frame: 12 months
|
The primary outcome is the rate of COVID-19 infections post vaccination in cancer patients compared to individuals without cancer, measured as confirmed COVID-19 infections by positive PCR COVID-tests (in asymptomatic or symptomatic cases within a period of up to 12 months post vaccination)
|
12 months
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Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 1 month after completion of vaccination
Time Frame: 1 month
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This primary outcome includes the antibody based immune response to COVID-19 vaccination measured 1 month after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA
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1 month
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Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 3 months after completion of vaccination
Time Frame: 3 months
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This outcome involves the persistence of antibody response to COVID-19 vaccination measured 3 months after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA
|
3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerance assessment - AEs; Incidence and severity of Adverse Events post vaccination
Time Frame: 12 months
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Incidence and severity of AEs post vaccination, with incidence and nature of AEs reported after each vaccination dose and up to 12 months post vaccination.
The number of participants with adverse events and the severity of adverse events will be recorded as assessed by CTCAE v4.0.
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12 months
|
Correlation of factors that might affect immune response in patients with cancer compared to individuals without cancer
Time Frame: 12 months
|
Correlation of factors (such as level of White Blood Count and Neutrophil Count prior to vaccination, type of cancer, type of cancer treatment, age and comorbidities) to the level of antibody response mounted post vaccination in patients with cancer.
Age-adjusted comparisons with the group of individuals without cancer.
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12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE_42C/21 ReCOVer study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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