SpikoGen® vaccine as booster dose in kidney transplant patients
- Conditions
- Covid-19.COVID-19, virus identifiedU07.1
- Registration Number
- IRCT20150303021315N28
- Lead Sponsor
- Shahid Beheshti university of medical sciences Urology and Nephrology Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Men and women older than 18
Patients with history of kidney transplantation who vaccinated with two doses Sinopharm vaccine after transplantation
Women who are not pregnant or breast-feeding
People who have been transplanted for more than 6 months
Subjects with active infection with signs of SARS-COV-2 at screening visit
History of covid-19 based on a previous positive PCR
Treatment of active Cytomegalovirus (CMV) infection
History of receiving rituximab during the past 6 months
History of receiving IVIg during the past 6 months
Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs
Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial
History of transplant rejection during the past 30 days
Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of seroconversion of antibody against spike protein. Timepoint: One month after booster dose. Method of measurement: ELISA and statistical analysis.;Evaluation of seroconversion of neutralizing antibodies. Timepoint: One month after booster dose. Method of measurement: ELISA and statistical analysis.
- Secondary Outcome Measures
Name Time Method