Status:
COMPLETED
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
Lead Sponsor:
Cinnagen
Collaborating Sponsors:
Shahid Beheshti University of Medical Sciences
Vaxine Pty Ltd
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05285384
Start Date
February 4 2022
End Date
March 30 2022
Last Update
August 31 2023
Active Locations (1)
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1
Shaheed Labbafinezhad Hospital
Tehran, Iran