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IRCT20150303021315N26 IRCT 2021-12-12 CinnaGen Company Comparison of immunogenicity and safety of SpikoGen vaccine as booster dose A randomized, two-armed, Placebo controlled (5:1), Double-blind, parallel clinical trial to compare the immunogenicity and safety of SpikoGen® vaccine (an adjuvanted recombinant spike (S) protein produced by CinnaGen Co.) as a booster dose 2021-12-16 anticipated 300 Complete https://irct.ir/trial/60375 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible participants will be assigned to treatment using permuted block randomization by R-CRAN-version 4.0.1. After randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the first two letters of first name, first two letters of surname) and 3 numbers (center code), first three letters of the generic name of the investigational product, i.e. VAC and three numbers (corresponding to the order in which the participant enters the study), e.g. ABCD001VAC-001.Randomization numbers are determined sequentially. Each vaccine syringe has a unique code that differs from the rest of the vaccines. The CRO is responsible for preparing the unique codes. Therefore, only the CRO knows each code for the vaccine (manufactured by CinnaGen) or placebo (0.9% normal saline). In case of enrollment, each subject will be given a randomization code and will be assigned to one of the groups. During each visit, a vaccine with a specific code will be given to the subject. The CRO will monitor how subjects are assigned to the treatment groups, Blinding description: The vaccine and the placebo have the same research label and are suitable for the vaccine boxes and syringes. The contents of the labels are based on EMA regulation. The SpikoGen® vaccine or placebo are packaged in the same way. Unique codes are printed on the vaccine and placebo labels, and each vaccine is linked to the participant through this unique code Participants and medical staff are not aware of the vaccine or placebo. The type of participants group and the type of vaccine they received will not be known for investigators and will be stored in opaque sealed envelopes at the center. Decoding under special circumstances, is the responsibility of the DSMB Committee. Decoding for a participant is done by the investigator of the center, when all of the possibilities in the occurrence of the event are evaluated and rejected. The vaccine or the placebo is recognized as the most important factor in the occurrence of an event or management of its complications which lead to special treatment for the participant and a decision that is not possible without decoding. 3 Covid-19. Intervention 1: 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. Intervention 2: Control group: Injecting one dose of 1 ml placebo containing normal saline (0.9% NaCl solution) in 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 Nassim Anjidani
No 42. Attar sq, Attar st, Valiasr st, Vanak sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 anjidani.n@orchidpharmed.com Orchid Pharmed scientific Payam Tabarsi
Masih Daneshvari Hospital, Darabad, Niavaran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 3000 tabarsi@nritld.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Men or women older than 18 years Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, and tests Individuals who received two doses of the SARS-CoV-2 vaccine with each platform within 4 to 9 months prior to the screening visit Healthy adults or adults with stable medical conditions 18 years no limit Both Subjects with active infection with SARS-COV-2 signs at the screening visit and 72 hours before the screening visit People with a history of Covid -19 after 2 doses of vaccination People with epilepsy or a history of febrile seizures People who are being treated with immunosuppressive drugs. Among the cytotoxic agents or systemic corticosteroids, for example, for cancer, autoimmune disease or organ transplants or require a specific medical prescription during the study period. Receiving cytotoxic and chemotherapy drugs at any dose will prevent people from entering the study People who have a history of severe allergic reactions (eg anaphylaxis) to any components of the vaccine being studied or other drugs Individuals who have received any other research product within 30 days prior to screening visit or intend to participate in another clinical study at the time of this study Individuals who received other authorized vaccines (such as Influenza vaccine or Gardasil) within 28 days prior to the screening visit in this study or intend to receive each vaccine up to 14 days after the second vaccination People who have a known bleeding disorder and who, according to the researcher, may have problems with the intramuscular injection Pregnant or breast-feeding women or women who plan to become pregnant up to 1 month after the booster dose People who have received or intend to receive any blood / plasma or immunoglobulin products during the 90 days prior to the screening visit People with special circumstances who, in the researcher's view, may increase the risk of participating in the study or interfering with the evaluation of the initial objectives of the study People who have donated more than or equal to 450 ml of blood or blood products in the 28 days before the screening visit U07.1 COVID-19, virus identified Prevention Placebo 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 Control group: Injecting one dose of 1 ml placebo containing normal saline (0.9% NaCl solution) in non-dominant arm Comparison of seroconversion for neutralizing antibodies in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA and statistical analysis. 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: Up to 14 days after booster dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system. Incidence of Serious Adverse Event and Suspected Unexpected Serious Adverse Reactions. Timepoint: during 6 months after booster dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system. Comparing GMC of antibodies against S protein. Timepoint: days 14,90,180. Method of measurement: ELISA test and statistical analysis. Comparing GMFR of antibodies against S protein. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis. Comparison of seroconversion of antibodies against S1 protein. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis. Comparison of seroconversion antibodies against RBD protein in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis. Comparison of GMC for Antibody against RBD protein in two groups. Timepoint: days 14,90,180. Method of measurement: ELISA test and statistical analysis. Comparison of GMFR for neutralizing antibodies against RBD in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis. Comparison of GMC for neutralizing antibodies against SARS-CoV-2 in two groups. Timepoint: days 14,90,180. Method of measurement: ELISA test and statistical analysis. Comparison of GMFR for neutralizing antibodies against SARS-CoV-2 in two groups. Timepoint: two weeks after booster dose. Method of measurement: ELISA test and statistical analysis. Evaluation of cellular immune response and Interferon Gamma release assay. Timepoint: days 0 and 14. Method of measurement: SARS-CoV-2 QuantiFERON Kit. CinnaGen Company Approved 2021-12-12 Iran National Committee for Ethics in Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran تهران Tehran Iran (Islamic Republic of)