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| Column | Value |
|---|---|
| Trial registration number | NCT05048940 |
|
Full text link
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 3, 2023, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : March 3, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
2021-09-17 |
|
Recruitment status
Last imported at : March 3, 2023, noon Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: patients who underwent solid organ transplantation prior to revaccination against covid-19. patients who have received the full covid-19 vaccination regimen with spikevax (moderna) vaccine, with a minimum of 8 weeks having elapsed from the second dose to the time of trial initiation. age > 18 years. all participants must have previously agreed to participate in the study by signing the informed consent form. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
having suffered sars-cov-2 infection at any time prior to inclusion in the study. subjects without solid organ transplantation or with a different solid organ (e.g. pancreas transplantation) and without any type of immunosuppression (immunocompetent non-transplanted) from the general population. age < 18 years temperature of at least 38°c in the 24 hours prior to immunization or other clinically relevant acute symptomatology. clinical manifestations compatible with covid-19 infection at the time of evaccination. known allergy or history of anaphylaxis or other serious adverse events to the administration of vaccines or their excipients. any other condition that contraindicates vaccination against sarscov2, including pregnancy. having presented graft rejection in the 15 days prior to the start of the study. any condition or situation that may interfere with the ability to maintain adherence to study procedures and visits. |
|
Number of arms
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Instituto de Investigación Marqués de Valdecilla |
|
Inclusion age min
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Spain |
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Type of patients
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 3, 2023, noon Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Changes in the production of anti-S1-RBD IgG antibodies. |
|
Notes
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Heterologous third dose;1;8 weeks after complete Spikevax (Moderna) regimen", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous third dose;1;8 weeks after complete Spikevax (Moderna) regimen", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |