| Trial registration number
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NCT04936997 |
Full text link
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04936997
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First author
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov
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Daniel Pennington, BS
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Contact
Last imported at : Dec. 10, 2021, 12:30 a.m.
Source : ClinicalTrials.gov
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danielpennington@arizona.edu
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Registration date
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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2021-06-23
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Recruitment status
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Single group assignment
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Masking
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
patients must have active solid tumor malignancy diagnosis
on active chemotherapy
received two prior sars-cov2 pfizer vaccines
age ≥ 18 years
ability to understand and the willingness to sign a written informed consent
agree to comply with study procedures
subjects previously enrolled under the main study
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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history of hiv or organ/bone marrow transplant
actively receiving immunotherapy
on active, chronic immunosuppression (>10 mg daily dose of prednisone equivalent)
currently incarcerated or residence of another state
speaks a language other than english.
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Number of arms
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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1
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Funding
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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University of Arizona
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Inclusion age min
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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20
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primary outcome
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Immune response
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Notes
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Phase 1
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Arms
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "3rd dose (2nd booster)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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