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| Column | Value |
|---|---|
| Trial registration number | NCT04969263 |
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Full text link
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
dose3@jh.edu |
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Registration date
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
2021-07-20 |
|
Recruitment status
Last imported at : March 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: individuals who meet all the following criteria are eligible for enrollment as study participants- able to understand and provide informed consent; recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment; received 2 doses of either the moderna covid-19 vaccine or pfizer-biontech covid-19 vaccine as specified in the respective food and drug administration emergency use authorization (fda euas), >30 days and <8 months prior to enrollment ; and, negative (antibody titer < 0.8u/ml) or low (antibodies detected at titer ≤ 50 u/ml) response to the vaccine at > 30 days from dose 2 of the moderna covid-19 vaccine or the pfizer biontech vaccine, using the roche elecsys® anti-receptor binding domain (rbd) assay. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
individuals who meet any of these criteria are not eligible for enrollment as study participants- recipient of any number of doses of any covid vaccine product other than the moderna covid-19 vaccine or the pfizer-biontech covid-19 vaccine; known history of severe allergic reaction to any component of either the moderna covid-19 vaccine or pfizer-biontech covid-19 vaccine; thrombotic events, myocarditis, or pericarditis temporally associated with prior dose of covid-19 vaccine; any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months; significant graft dysfunction; receipt of any cellular depleting agent (e.g. atg, rituximab, alemtuzumab, cyclophosphamide) within 12 months preceding enrollment; receiving systemic immunomodulatory medication(s) for any condition other than transplant; any untreated active infection, including bk viremia >10^4 copies; infection with human immunodeficiency virus (hiv); maintenance immunosuppressive regimen that includes belatacept or abatacept; recent (within one year) or ongoing treatment for malignancy; or any past or current medical problems, treatments, or findings which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the candidate's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study. |
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Number of arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Inclusion age min
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Oct. 6, 2021, 11:30 a.m. Source : ClinicalTrials.gov |
81 |
|
primary outcome
Last imported at : Jan. 24, 2024, midnight Source : ClinicalTrials.gov |
Antibody Response to Third Dose of mRNA COVID-19 Vaccine |
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Notes
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "100 \u03bcg;1;IM (third dose)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u03bcg;1;IM (third dose)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |