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IRCT20171122037571N3 IRCT 2021-11-11 SHIFAPHARMED Industrial Group Co Phase Ⅰ/Ⅱ clinical trial of Shifa-Pharmed COVID-19 inactivated vaccine (CovIran-Barkat) among healthy adolescents aged 12 to 18 years. Comparison of the tolerability, safety, and immunogenicity of Shifa-Pharmed COVID-19 inactivated vaccine (CovIran) and Sinopharm vaccine in the healthy population aged 12 to 18 years: a double-blind, randomized, active-controlled, Phase I-II clinical trial. 2021-11-15 anticipated 500 Complete https://irct.ir/trial/59490 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Phase one: will be conducted in 2 stages: First stage: Initially, 10 participants who meet the criteria receive a dose of vaccine (two participants aged 17-18 years, two aged 15-16 years, three aged 13-14 and finally three aged 12 years old), and are followed up for any adverse events. Second stage: if no serious adverse event was detected within 48 hours, the rest of the participants (50 cases) will receive the CovIran vaccine (20 individuals) or Sinopharm vaccine (30 individuals). For this purpose, ten permuted block random with the size of 5 is produced, each including 2 vaccines and 3 placebo codes. Permuted block randomisation for 440 participants is planned by 110 random blocks of 4, each including 2 vaccines and 2 placebos via an online system (http://sealedenvelope.com), 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. 1-2 COVID-19 disease. Intervention 1: Intervention group: Intramuscular injection (deltoid muscle) of 0.5 ml Shifa-Pharmed inactivated vaccine (CovIran- Barkat) on days 0 and 28. Intervention 2: Control group: Intramuscular injection (deltoid muscle) of 0.5 ml Sinopharm vaccine on days 0 and 28. 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 Undecided - It is not yet known if there will be a plan to make this available
public Hasan Jalili
Soha St., Shifa St.,Mapna Blv
Kordan Iran (Islamic Republic of) 1417993337 +98 21 9109 0245 hjalili@ut.ac.ir SHIFAPHARMED Industrial Group 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 12 to 18 years According to the protocol, the volunteer and their legal guardian be able and willing to cooperate with the researchers throughout the study period. The volunteer and/or their legal guardian are able to fully understand the executive processes of the study and to understand the explanations of the facilitators correctly. The volunteer and/or their legal guardian are able to understand the contents of the informed consent form and sign the informed consent before interring in the study. The volunteer and/or their legal guardian allow the researchers to access medical records and test results if hospitalised for any reason including due to the suspected or confirmed COVID-19. Healthy general condition according to medical history and initial medical examinations. BMI of higher than 3rd percentile according to WHO standards for child growth at visit day (day 0). Volunteers and their legal guardians agree not to donate blood, blood products, or bone marrow from the time of vaccine inoculation until 3 months after receiving the last dose of the vaccine Women with fertility potential: Negative pregnancy test on the first day of injection (day zero) and day of the second injection (day 28). Furthermore, volunteers should use the effective contraception method 28 days before the first dose and continue to use it for at least three months after the second dose. 12 years 18 years Both Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline. Positive Neutralizing antibody or COVID-19 nucleocapsid antibody (N-protein) on the day of the screening visit. History of SARS-CoV-2 infection (documented rtPCR) History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days During the period of home quarantine due to Covid-19 (suspicion of exposure or suspicious symptoms). In the 14 days prior to vaccination, fever or presence of at least two symptoms from Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhoea, dyspnea, and shortness of breath Abnormality in biochemistry, blood and urine laboratory tests prior to vaccination(biochemistry including Na, K, BUN/Urea, creatinine, FBS, Liver function tests: AST, ALT, ALP, total bilirubin, CBC: leukocyte count, Hemoglobin, platelet, neutrophil. lymphocyte, urine analysis: protein, glucose and blood cells (Microscopic examination). History of severe allergy, urticaria or allergic reactions to COVID-19 Inactivated vaccine ingredients (allergic to Aluminium). Personal or family history of seizure, epilepsy, encephalopathy or mental disorders, Congenital malformations, History of neurologic disorders or seizure (excluding febrile seizure). Any genetic disorder. History or signs of malnutrition, history of growth disorders. Uncontrolled hypertension, any hepatic or renal disease, Diabetes mellitus, chronic pulmonary disease and asthma, chronic kidney disease, serious cardiovascular disorders such as congenital heart defects, arrhythmia, heart blocks, ..., any type of malignancy, thyroid disease, history of coagulation disorders. Any acute diseases or an exacerbation of a chronic disease in the last 7 days prior to study. Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases. Receive immunosuppressive drugs or corticosteroids in the last 6 months Splenectomy or history of any organ removal History of dermatological disorders that can cause local complications at the injection site. History of hereditary and acquired angioedema over the past year Receiving Anti-TB treatment Positive HBsAg/ Positive HCV antibody History of any substance abuse (including alcohol, opium, etc.) / Recent history of inhaled use of substances such as tobacco, cannabis, and etc 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 Receiving any other investigational COVID-19 vaccine Receiving immunoglobulins or blood products in 3 months before inoculation Receiving any other investigational drug in 6 months before inoculation and/or planning to receive any other vaccine in one month after inoculation Participation in any interventional clinical trial within 28 days prior to receiving the first dose or willingness to participate during the present study period History of severe mental disorders affecting the participation in the study Women with a positive pregnancy test (Beta HCG in a blood sample) or breastfeeding or those who intend to become pregnant during the study period. First-degree relatives of any member of the research team (including the study sponsor) Any other circumstances are other than the above-mentioned ones that the researcher deems inappropriate for a person participating in a clinical trial. These cases are recorded as the reason for not entering. U07.1 COVID-19, virus identified Prevention Prevention Intervention group: Intramuscular injection (deltoid muscle) of 0.5 ml Shifa-Pharmed inactivated vaccine (CovIran- Barkat) on days 0 and 28 Control group: Intramuscular injection (deltoid muscle) of 0.5 ml Sinopharm vaccine on days 0 and 28 Phase 1: Any immediate reaction after inoculation. Timepoint: 0-30 minutes after inoculation. Method of measurement: Close observation. Phase 1: 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. Phase 1: Percentage of systemic events (fever, headache, chills, nausea, vomiting, diarrhoea, fatigue, muscle pain, arthralgia, ....). 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. Phase 1: occurrence of any adverse event (serious or non-serious). 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. Phase 2: Percentage of seroconversion occurrence. Timepoint: Days 0, 7 , 28, 42, 90, 180, 360. Method of measurement: ELISA assay. Phase 2: Anti-Spike, Neutralizing Antibody, Anti-RBD titres (with GMT , GMI). Timepoint: Days 0, 7, 28, 42, 90, 180, 360. Method of measurement: ELISA assay. Phase 2: Lymphocytes subset count and cytokines for determining cellular immunity. Timepoint: Days 0, 28. Method of measurement: ELISA assay. Phase 1: occurrence of any Systemic events. Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 1: Any adverse events (serious or non-serious). Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 1: seroconversion occurrence. Timepoint: Days 0, 7 , 28, 42, 90, 180, 360. Method of measurement: ELISA assay. Phase 1: Lymphocytes subset count and cytokines for determining cellular immunity. Timepoint: Days 0, 28. Method of measurement: ELISA assay. Phase 1: Anti-Spike, Neutralizing antibody, Anti-RBD titres (with GMT, GMI). Timepoint: Days 0, 7 , 28, 42, 90, 180, 360. Method of measurement: ELISA assay. Phase 1: Occurrence and the severity of SARS-COV-2 infection. Timepoint: 180 days after last inoculation. Method of measurement: Comparing confirmed COVID-19 cases, severity status is categorised as non-severe, severe, and critical based on the WHO diagnosis scheme. Phase 2: Any immediate reaction after inoculation. Timepoint: 0-30 minutes after inoculation. Method of measurement: Close observation. Phase 2: Local reactions in injection site (pain, redness, swelling, ....). 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. Phase 2: Percentage of systemic reactions (fever, headache, chills, nausea, vomiting, diarrhea, fatigue, myalgia, arthralgia, ....). Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 2: Any adverse events (serious or non-serious). Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Phase 2: Occurrence and the severity of SARS-COV-2 infection. Timepoint: 180 days after last inoculation. Method of measurement: Comparing confirmed COVID-19 cases, severity status is categorised as non-severe, severe, and critical based on the WHO diagnosis scheme. SHIFAPHARMED Industrial Group Co Approved 2021-11-07 National research ethics committee 13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake ghods(qarb) Tehran Tehran Iran (Islamic Republic of)