]>
IRCT20150303021315N28 IRCT 2022-02-02 Shahid Beheshti university of medical sciences Urology and Nephrology Research Center SpikoGen® vaccine as booster dose in kidney transplant patients A single armed, open label, clinical trial to evaluate the immunogenicity of SpikoGen® vaccine as booster dose (Spike protein, produced by CinnaGen company) in kidney transplant patients being fully vaccinated with Sinopharm vaccine 2022-02-04 anticipated 100 Complete https://irct.ir/trial/61472 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. N/A Covid-19. 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Shiva Samavat
Between 8th Neyestan and 9th Boostan St, Pasdaran Ave.
Tehran Iran (Islamic Republic of) 1666650003 +98 21 2259 0607 shsamavat @gmail.com Shahid Beheshti University of Medical Sciences scientific Mohsen Nafar
9th Boostan Alley, Pasdaran St.
Tehran Iran (Islamic Republic of) 1666650003 +98 21 2259 0607 mohsen.nafar.sbmu@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 U07.1 COVID-19, virus identified Prevention 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 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. 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. Shahid Beheshti university of medical sciences Urology and Nephrology Research Center Approved 2022-01-22 Ethics Committee of Urology and Nephrology Research Center-Shahid Beheshti university of medical sci N0.103, 9th Boostan, Pasdaran Ave. Tehran Tehran Iran (Islamic Republic of)