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| Column | Value |
|---|---|
| Trial registration number | NCT05285384 |
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Full text link
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
shsamavat@gmail.com |
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Registration date
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
2022-03-17 |
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Recruitment status
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : March 20, 2022, 9:56 a.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 : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
inclusion criteria: male or female ≥18 years willing and able to comply with all study requirements, including scheduled visits, intervention, and laboratory tests kidney transplant recipients who had received two doses of sinopharm vaccine after transplantation females must not be pregnant or breastfeeding at least six months should have passed from the time of transplantation between 1 to 3 months should have passed from the second dose of sinopharm vaccine |
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Exclusion criteria
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
subjects with signs of active sars-cov-2 infection at the screening visit subjects with a history of sars-cov-2 infection based on a positive pcr test result after the second dose of the primary vaccination subjects with an active cmv infection that requires treatment subjects who have received rituximab within 6 months prior to the screening visit subjects who have received intravenous immune globulin (ivig) within 6 months prior to the screening visit subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products. subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study. subjects who have experienced transplant rejection within 30 days prior to the screening visit subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion. |
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Number of arms
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Cinnagen |
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Inclusion age min
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Iran;Islamic Republic of |
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Type of patients
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
100 |
|
primary outcome
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Percentage of participants with seroconversion for S1 binding IgG antibodies;Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies |
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Notes
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Booster", "treatment_id": 2301, "treatment_name": "Advax-sm adjuvant+sars-cov-2 spike (s) protein subunit vaccine", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}] |