Covid-19. COVID-19, virus identified
Conditions
Interventions
Intervention group: Injecting one dose of 1 ml solution of SpikoGen® vaccine containing recombinant SARS-CoV-2-S protein and Advax™ and CpG adjuvants in the non-dominant arm.
Sponsors
Shahid Beheshti university of medical sciences Urology and Nephrology Research Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Evaluation GMFR of antibodies against S protein. Timepoint: One month after booster dose. Method of measurement: ELISA test and statistical analysis.;Evaluation of GMFR for neutralizing antibodies. Timepoint: One month after booster dose. Method of measurement: ELISA test and statistical analysis.;Evaluation GMFR of antibody against S protein in subgroups with initial response and no initial response to Sinopharm vaccine. Timepoint: One month after booster dose. Method of measurement: ELISA test and statistical analysis.;Evaluation GMFR of neutralizing antibodies in subgroups with initial humoral response and no initial humoral response to Sinopharm vaccine. Timepoint: One month after booster dose. Method of measurement: ELISA test and statistical analysis.;Evaluation of seroconversion against S protein in subgroups with initial humoral response and no initial humoral response to Sinopharm vaccine. Timepoint: One month after booster dose. Method of measurement: ELISA test and statistical analysis.;Evaluation of seroconversion of neutralizing antibodies in subgroups with initial humoral response and no initial humoral response to Sinopharm vaccine. Timepoint: One month after booster dose. Method of measurement: ELISA test and statistical analysis.;Evaluation of cellular immune response. Timepoint: One month after booster dose. Method of measurement: SARS-CoV-2 QuantiFERON Kit.;Occurrence of solicited adverse events. Timepoint: Up to 7 days after booster dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Occurrence of unsolicited adverse events. Timepoint: One month after booster dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShiva Samavat
Shahid Beheshti University of Medical Sciences
Outcome results
None listed