Clareo Health | Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cinnagen
With
Shahid Beheshti University of Medical Sciences
Vaxine Pty Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
