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IRCT20150303021315N24 IRCT 2021-08-03 CinnaGen Company Evaluation of efficacy and safety of SpikoGen® vaccine on adults to prevent COVID-19 disease A phase III, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen®) produced by CinnaGen Co. (Two doses of 25µg with dosing interval of 21 days) 2021-08-04 anticipated 16876 Complete https://irct.ir/trial/57559 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible patients will be assigned to treatment using a stratified randomization by R-CRAN-version 4.0.1. Randomization will be stratified according to two factors: Age (Below the age of 40– equal or above the age of 40 - below 50) 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). Moreover, the described code is followed by study unique identification code consisting of first three letters of the generic name of the investigational product, i.e. VAC and five numbers (corresponding to the randomization number), e.g. ABCD001VAC-00001. 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 or blind breaking, 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 on days 0 and 21. Intervention 2: Control group: Injecting one dose of 1 ml placebo containing normal saline (0.9% NaCl solution) in non-dominant arm on days 0 and 21. 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 Ethical Concerns
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) 19569-44413 +98 21 2712 3000 tabarsi@nritld.ac.ir Shahid Beheshti University of medical Sciences Iran (Islamic Republic of) Men or women 50 > age ≥ 18 Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations and tests Healthy adults or adults with stable medical conditions Women eligible to participate in the study who are not pregnant or breastfeeding 18 years 50 years Both Subjects with active infection with SARS-COV-2 signs at the screening visit Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or during the visit Subjects with any progressive or severe neurological disorder, including dementia, stroke, seizures, or a history of Guillain-Barre syndrome High-risk subjects who are prioritized for the national vaccination program, those are treated with immunosuppressive drugs or cytotoxic drugs, or systemic corticosteroids at doses ≥ 10 mg daily of prednisolone or equivalent doses of other corticosteroids more than 14 days Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study 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 Subjects who have been vaccinated with other vaccines against the SARS-CoV-2 virus Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit 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 Subjects who have donated ≥450 ml of blood or blood products 28 days prior to the screening visit Subjects who are given the priority of vaccination within 2 months after participating in the study, according to the national immunization program Subjects with ESRD Subjects with dawn syndrome Subjects with BMI ≥ 40 Subjects with cystic fibrosis, COPD, PAH Subjects with uncontrolled asthma Subjects with uncontrolled hypertension Subjects with uncontrolled diabetes Mellitus 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 on days 0 and 21 Control group: Injecting one dose of 1 ml placebo containing normal saline (0.9% NaCl solution) in non-dominant arm on days 0 and 21 Evaluation of COVID-19 incidence. Timepoint: 14 days after the second dose. Method of measurement: Participants must have at least two of the following systemic symptoms: fever (38 ° C), chills, myalgia, headache, sore throat, nausea, vomiting, diarrhea, nasal discharge, new olfactory disorder, "or" the participant must have experienced at least one of the following respiratory signs and symptoms: cough, shortness of breath, clinical or radiographic evidence of pneumonia "and" at least one positive PCR test for SARS-CoV-2. Evaluation of severe COVID-19 incidence. Timepoint: 14 days after the second dose. Method of measurement: If the patient has any of the following symptoms, is classified as severe type of COVID-19: respiratory rate ≥30 per minute. Heart rate ≥125 per minute. Oxygen saturation ≤93% in ambient air. Respiratory failure or acute respiratory distress syndrome (ARDS) or (requires high-flow oxygen or non-invasive or mechanical ventilation or ECMO) Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg) or the need for vasopressors). Acute renal, hepatic or neurological dysfunction. Hospitalization in the intensive care unit or death. Occurrence of solicited adverse events. Timepoint: Up to 7 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system. Occurrence of unsolicited adverse events. Timepoint: Up to 28 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system. Occurrence of serious adverse events and suspected unexpected serious adverse events. Timepoint: within 6 months after the second dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system. CinnaGen Company Approved 2021-07-28 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. Tehran Tehran Iran (Islamic Republic of)