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IRCT20201202049567N1 IRCT 2020-12-15 Shifa Pharmed Industrial Co. Phase 1 clinical trial of an inactivated COVID-19 vaccine (Shifa-Pharmed) in healthy individuals A double-blinded, randomized, placebo-controlled Phase I Clinical trial to evaluate the safety and immunogenicity of COVID-19 inactivated vaccine (Shif-Pharmed) in a healthy population 2020-12-21 anticipated 56 Complete https://irct.ir/trial/52701 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: The Data and Safety Monitoring Board (DSMB) oversees the safety of participants throughout the study. The committee consists of seven independent members (including infectious disease specialist, immunologist, virologist, epidemiologist, vaccinologist, etc.).The DSMB is held at intervals of 7 days after the recruitment of first 3, 7, 14, 21 volunteers and then 14 days after the enrolment of 35th and 28 days after the 56th participant. The safety profile of the candidates is reviewed individually and the result of the committee is submitted to the regulatory body. The progress of the trial to next stage occurs only with the DSMB approval and the national regulatory authorities, Randomization description: A two-stage individual permuted block randomization is planned for the study. At the first stage, 14 participants randomly receive a low dose of 3 micrograms (12 candidates) or placebo (2 volunteers). For this purpose, two random block sequences with size 7 are produced, including 6 vaccines and one placebo code. After getting approval for the safety of the low-dose vaccine, in the second stage, 42 volunteers are randomly assigned to the intervention group of 3 micrograms (12 participants), 5 micrograms (24 participants), and the placebo (6 participants). For this purpose, 6 blocks with size 7 (2 people in the group of 3 micrograms, 4 people in the group of 5 micrograms, one person in the placebo group) will be generated. All random allocation processes will be performed by an interactive web response system (IWRS), Blinding description: Every dose of vaccine is packaged separately and has a unique identification number. Vials and boxes of vaccine and placebo have a similar shape and packaging that results in blinding for participants, investigators, and outcome assessors. 1 COVID-19 disease. Intervention 1: Intervention group 1: 3 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and 14, which is received intramuscularly (deltoid muscle). Intervention 2: Intervention group 2: 5 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and14, which is received intramuscularly (deltoid muscle). Intervention 3: Control group: The placebo group will receive only aluminum hydroxide adjuvant in the form of deltoid intramuscular injection on days 0 and 14. Placebo is similar to the active vaccine in shape and volume. 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 It will be decided based on the regulatory considerations.
public Mohammadreza Hosseinpour
Soha St., Shifa St.,Mapna Blv
Kordan Iran (Islamic Republic of) 1417993337 +98 21 9109 0245 mr.hosseinpour@shifapharmed.com Shifa Pharmed Industrial Co. scientific Minoo Mohraz
AIDS research center, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417993337 +98 21 6658 1583 minoomohraz@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Aged 18 to 50 years Healthy general condition according to medical history and initial medical examinations Willing and able to cooperate throughout the study period according to the study protocol Being able to fully understand the study processes and understand the explanations of the facilitators correctly Being able to understand the contents of the informed consent form and sign it before entering the study Allowing researchers access to medical records, test results if hospitalized due to suspicion, or approval of COVID-19 A negative pregnancy test at screening or vaccination (women only) Using effective methods of contraception during the study (male and female) Volunteers who agree not to donate blood, blood products, or bone marrow from the start of the vaccine until three months after receiving the last dose 18 years 50 years Both Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline. COVID-19 positive antibody History of SARS-CoV-2 infection History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days People in the home quarantine period due to Covid (suspicion of exposure or suspicious symptoms) Fever (axillary temperature greater than 37 ° C) Dry cough, extreme tiredness, nasal congestion, runny nose, sore throat, muscle aches, diarrhea, dyspnea, and shortness of breath during the 14 days prior to vaccination Abnormality in biochemistry, blood and urine laboratory tests History of severe allergy or allergic reactions to Inactivated vaccine components Personal or family history of seizure, epilepsy, encephalopathy or mental disorders Congenital malformations History of neurologic disorders or seizure or Guillain-Barre syndrome (excluding childhood febrile seizure) Growth disorders Any Genetic disorder History or signs of malnutrition Hepatorenal diseases Uncontrolled hypertension Diabetes complications BMI > 40 Any malignancy Acute diseases or an exacerbation of a chronic disease in the last 7 days Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases Thyroid disease or history of thyroidectomy Splenectomy or history of any organ removal History of coagulopathy Receiving Anti-TB treatment Positive HBSAg Positive HIV test Positive HCV antibody Receiving immunomodulators or immunosuppressors at least 14 days in the past 3 months Receiving live vaccine in one month or other vaccines in 14 days before inoculation History of drug or alcohol abuse Receiving immunoglobulins or blood products in 3 months before inoculation Receiving any other investigational drug in 6 months before inoculation Planning to receive any vaccination in on month after inoculation History of severe mental disorders affecting the participation in the study Pregnant or lactating women or those who intend to become pregnant during the study period Having a high-risk job of being exposed to the SARS-CoV-2 virus or having a high risk of exposure according to the investigator evaluation Any other condition that makes a person inappropriate for participation based on the investigator opinion U07.1 COVID-19, virus identified Prevention Prevention Placebo Intervention group 1: 3 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and 14, which is received intramuscularly (deltoid muscle). Intervention group 2: 5 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and14, which is received intramuscularly (deltoid muscle). Control group: The placebo group will receive only aluminum hydroxide adjuvant in the form of deltoid intramuscular injection on days 0 and 14. Placebo is similar to the active vaccine in shape and volume. Any immediate reaction after inoculation. Timepoint: 0-30 minute after inoculation. Method of measurement: Close observation. Percentage of local reactions (pain, redness, swelling, ....in injection site). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Percentage of systemic events (fever, headache, chills, vomiting, diarrhea, fatigues, muscle pain, joint pain, ....). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Incidence of any adverse event (AE). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Incidence of any serious adverse event (SAE). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Any adverse events (AEs or SAEs). Timepoint: From Days 7 to 28 after inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Percentage of seroconversion occurrence. Timepoint: Days 0, 7 , 14, 21, 28, 90, 180, 360. Method of measurement: At least a 4-fold increase in antibody titer (IgG and IgM) above baseline : ELISA assay. Antibody- IgG and IgM titer (The geometric mean titer of antibody). Timepoint: Days 0, 7 , 14, 21, 28 and 90, 180, 360 (follow up period). Method of measurement: ELISA. Neutralizing antibody activity. Timepoint: Days 0, 7 , 14, 21, 28 and 90, 180, 360 (follow up period). Method of measurement: ELISA. Lymphocytes subset count (Including CD3+, 4+, 8+, NK cell, B cell, ...). Timepoint: Days 0, 14 and 28 after inoculation. Method of measurement: Flow Cytometry. Cytokine assay (including IL 1, 2,4,5,6,8,10,12,17A,17F,21IFN- gamma, TNF - alpha). Timepoint: Days 0, 14 and 28 after inoculation. Method of measurement: ELISA. The severity of SARS-COV-2 infection (if present). Timepoint: Any time after inoculation: days 0 to 28. Method of measurement: Clinical grading. Shifa Pharmed Industrial Co. Approved 2020-12-02 National research ethics committee 13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake ghods Tehran Tehran Iran (Islamic Republic of)