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IRCT20201214049709N5 IRCT 2022-02-09 Razi Vaccine and Serum Research Institute Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy children and adolescents aged 5-17 years Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy children and adolescents aged 5-17 years; single group, open label study 2022-06-25 anticipated 420 Complete https://irct.ir/trial/61378 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. 1-2 SARS-CoV-2. Intervention group: Participants in the 12-17 years age group will receive two intramuscular doses of 10μg/200μl vaccine strengths on days 0 and 21, followed by an intranasal dose on day 51. Participants in the 5-11 years age group will receive half the dose of 12-17 years old's with the same administration schedule.. Yes - There is a plan to make this available What will be shared: De-identified IPD related to outcome will be shared. When: The access period will begin once the study is complete and the main results have been published in peer reviewed journals. To whom: The data that have been published in peer reviewed journals, will be available just for academic researchers. Conditions: The proposed study protocol should be submitted to RAZI vaccine and serum research institute and approved by its scientific and technical committee Where to obtain: After publishing the article, researchers can submit their request to Dr. Mohammad Hossein Fallah at the following email address (mhf2480@yahoo.com ) How to obtain: Data will be made available after consideration and approval by the relevant authorities from Razi Vaccine and Serum Research Institute. Comments:
public Mohammad Hossein Fallah Mehrabadi
Hesarak - Shahid Beheshti street- Karaj
Karaj Iran (Islamic Republic of) 3197619751 +98 26 3457 0038 mhf2480@yahoo.com Razi Vaccine and Serum Research Institute scientific Saeid Kalantari
Corner of Mansouri, Niayesh, Satarkhan Av, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6435 1000 kalantari.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Participants legal guardian should be able to read and write Age between 5-17 years Having good health based on clinical and laboratory criteria Negative RT-PCR test for COVID-19 Signed the informed consent form Not pregnant Negative beta HCG pregnancy test on screening and vaccination day Use of at least one effective method of contraception (condoms, oral contraceptive pills, intrauterine device, Norplant capsule) and willing to continue using it in female couples 5 years 17 years Both Any ongoing, symptomatic acute or chronic illness requiring continuous medical or surgical care on the day of vaccination Breastfeeding Received any Covid Vaccine Received any vaccine during the 14-days period prior to the screening day Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day History of long-term use of immunosuppressive medication (defined as more than 14 consecutive days) in the last 6 months leading up to screening day Long-term use (defined as more than 14 consecutive days) of systemic corticosteroids within the past 6 months leading up to screening day History of severe allergic diseases (such as Dyspnea, angioedema, anaphylactic reactions, urticaria and eczema) History of allergy to any drug or vaccine (defined as any clinical signs or symptom of itching at the injection site, urticaria in the body after injection, excessive redness at the injection site) History of immunological disorder (congenital or acquired) History of chemotherapy in the last 5 years History of cancer in the last 5 years History of acute and serious psychiatric illnesses History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, deficiency of blood factors) Severe acute or chronic renal or hepatic failure based on laboratory parameters Suffering from chronic obstructive pulmonary disease such as asthma, or severe renal/hepatic diseases requiring continuous treatment by a specialist Uncontrolled hypertension Uncontrolled Diabetes History of chronic neurological diseases (including seizures and epilepsy) Any history of substance or alcohol abuse Grade 1 or higher abnormal laboratory (hematology or biochemistry) tests based on toxicity score on the screening day History of confirmed COVID-19 diseases during the 6-months period before the screening day (positive PCR test or clinical diagnosis) Acute febrile illness at the time of vaccination History of allergy to acetaminophen Receiving prophylactic drug against tuberculosis History of faint when see blood Splenectomy for any reason Any close contact with a confirmed COVID-19 case within two weeks before the first dose of vaccine Congenital disorders, developmental disorders, severe malnutrition or genetic diseases Participating in any clinical trials (research) other than this study U07.1 COVID-19 Prevention Intervention group: Participants in the 12-17 years age group will receive two intramuscular doses of 10μg/200μl vaccine strengths on days 0 and 21, followed by an intranasal dose on day 51. Participants in the 5-11 years age group will receive half the dose of 12-17 years old's with the same administration schedule. Abnormal vital signs and anaphylactic reactions immediately after vaccination: Number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and after vaccination. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked after each vaccination. Timepoint: Before vaccination and 30 minutes after vaccination at each dose. Method of measurement: Temperature is measured using a digital thermometer. Blood pressure will be measured using a digital sphygmomanometer. Local adverse reactions: The number and percentage of local adverse reactions within the first week post-vaccination (including pain, tenderness, erythema/redness, swelling and stiffness, itching). Timepoint: The first seven days after 1st and 2nd vaccine dose (Days 0-7 and 21-28). Method of measurement: The required information will be collected using the application installed on the mobile phones of the volunteer or their legal guardian. Volunteer will be contacted if they do not complete the relevant forms on their application. Systemic adverse event: The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain). Timepoint: The first seven days after each vaccine dose (Days 0-7, 21-28, 51-58). Method of measurement: The required information will be collected using the application installed on the mobile phones of the volunteer or their legal guardian. Volunteer will be contacted if they do not complete the relevant forms on their application. ََAbnormal laboratory findings: The number and percentage of people who show abnormal laboratory findings one week after vaccination (Based on toxicity scores), including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes, Neutrophils, Eosinophils, Platelets ESR, CRP, Sodium, Potassium, BUN, Creatinine, Alkaline phosphatase, ALT, AST, and U/A, Urine protein, Urine glucose, Urine RBC. Timepoint: Seven days after each vaccine dose (Days 7, 28, 58). Method of measurement: Each test will be performed using the appropriate kit. Measurement of neutralizing antibody titers to assess humoral immunity. Timepoint: Neutralizing antibody titers will be assessed on days 0, 35, 90 and 180 and comparison will be made between day 0 and other time points. Method of measurement: Conventional Virus Neutralization Test (cVNT). Severe Adverse event (SAEs), Suspected Unexpected Serious Adverse Reaction (SUSAR ) and Medically Attended Adverse Events (MAAEs). Timepoint: Weekly until sixth month after second vaccine dose. Method of measurement: The required information will be collected using a weekly questionnaire delivered through the installed application on the volunteer mobile phone or their legal guardian. Volunteer will be contacted if they do not complete the relevant forms on their application. Measurement of serum levels of specific IgG antibodies against S1 and RBD components of SARS-CoV-2 spike protein antigen (s). Timepoint: Measurement will be done on days zero, 35, 90 and 180 and comparison will be made between day 0 and other time points. Method of measurement: Will be measured using ELISA method. Evaluation of cell-mediated immunity by counting CD3, CD4 and CD8 cells number. IFN-γ, TNF-α, and interleukin 2, 4, 6, and 17 will also be measured following the stimulation of peripheral blood mono nuclear cells by covid 19 s antigen. Evaluation of cell mediated immunity will be performed only in 10% of participants. Timepoint: Cell mediated immunity will be assessed on days 0, 35, 90 and 180 and comparison will be made between day 0 and other time points. Method of measurement: Immunologic lab tests. Razi Vaccine and Serum Research Institute Approved 2022-02-06 National Research Ethics Committee Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of) Approved 2022-06-08 National Research Ethics Committee Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)