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| Column | Value |
|---|---|
| Trial registration number | NCT04715438 |
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Full text link
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
2021-01-20 |
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Recruitment status
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
inclusion criteria: to be eligible to participate in this study, a subject must meet all of the following criteria: - age of 18 years or older - life expectancy > 12 months - ability to provide informed consent additional criteria for cohort a: • partner of a participating patient additional criteria for cohort b: - histological diagnosis of a solid malignancy - treatment with monotherapy immune checkpoint inhibitor (ici) against programmed death 1 (pd1) or its ligand pd-l1 (in curative or non-curative setting) - last ici administration within 3 months of vaccination additional criteria for cohort c: - histological diagnosis of a solid malignancy - treatment with cytotoxic chemotherapy (monotherapy and combination chemotherapy is allowed, as well as a combination with radiotherapy, in curative or non-curative setting) - last chemotherapy administration within 4 weeks of vaccination additional criteria for cohort d: - histological diagnosis of a solid malignancy - treatment with a pd1 or pd-l1 antibody in combination with cytotoxic chemotherapy (in curative or non-curative setting) - last chemotherapy administration within 4 weeks of vaccination - last ici administration within 3 months of vaccination |
|
Exclusion criteria
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
- confirmed sars-cov-2 infection (current or previous) - women who are pregnant or breastfeeding - active hematologic malignancy - any immune deficiency not related to cancer or cancer treatment (e.g. inherited immune deficiency or known infection with human immunodeficiency virus) - systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of vaccination. inhaled or topical steroids, and adrenal replacement steroids (> 10 mg daily prednisone equivalent) are permitted. in addition, standard of care with short course steroids to prevent nausea and allergic reactions from chemotherapy or iodinated ct contrast is allowed. additional criteria for cohort a: - current or previous diagnosis of a solid malignancy, unless treated with curative intent >5 years before enrolment and without signs of recurrence during proper follow-up - previous history of a hematologic malignancy additional criteria for cohort b: • treatment with cytotoxic chemotherapy within 4 weeks of vaccination additional criteria for cohort c: • treatment with an ici within 3 months of vaccination |
|
Number of arms
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
University Medical Center Groningen |
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Inclusion age min
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Netherlands |
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Type of patients
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
791 |
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primary outcome
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml |
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Notes
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Cohort A: Individuals without cancer", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort B: patients receiving immunotherapy", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort C: patients receiving chemotherapy", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort D: patients receiving chemo-immunotherapy", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |