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IRCT20210206050259N2 IRCT 2021-06-08 Organization of Defensive Innovation and Research Trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) Phase 2 trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine (FAKHRAVAC), two doses two weeks apart in adults aged 18-70 years: a randomized, double-blind, placebo-controlled, clinical trial 2021-06-09 anticipated 500 Complete https://irct.ir/trial/56027 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the Block Randomization method with a block size of 4 was used to assign each participant to the intervention groups. The rand() function of Excel software will be used to generate random sequences within each block. After determining the allocated intervention, a non-repetitive four-digit random code was assigned to each participant. Assigned codes will be delivered to the eligible participants via software, Blinding description: In this study, placebo will be used. Adjunct only IMP will be used as placebo. All people involved in the study will be blind to the type of IMP received except the epidemiologist responsible for unblinding. In cases of any serious adverse event or any trend in the occurrence of adverse events towards one of the groups, unblinding will occur by DSMB request. On other clinical occasions, unblinding could occur by the principal investigators' approval. 2 SARS-CoV-2. Intervention 1: Intervention group: Two doses of 10 micro gram vaccine injected in the deltoid muscle (IM) at 14 days interval. Intervention 2: Control group:Two doses of placebo injected in the deltoid muscle (IM) at 14 days interval. Yes - There is a plan to make this available What will be shared: Deidentified IPD on study outcomes could be shared. When: After completion of the study and publication of the results, data could be shared for 2 years To whom: Data is available only to members of academic institutions within joint projects with MILAD Daru Nour Co. Conditions: Proposal should be presented to MILAD Daru Nour Co and its necessity and scientific validity should be approved by the company Where to obtain: You can contact Ms Kousar Naderi at k.naderi@strc.ac.ir How to obtain: Request for data will be made available within the approved joint projects Comments:
public Mohsen ForughiZadeh Moghadam
No. 12, Zomorod 1 block, Noor 1 St., Shahid Mahalati Town
Tehran Iran (Islamic Republic of) 1955737134 +98 21 8008 6783 Foroughizadeh@modares.ac.ir Malek Ashtar University scientific Ramin Hamidi Farahani
NO.9, Unit 3, Mirsharifi, Valiasr St.
Tehran Iran (Islamic Republic of) 1986936911 +98 21 8833 7912 Rgsramin@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Age 18 to 70 years Body mass index between 18 and 35 kg per square meter No current or previous COVID-19 disease No pregnancy Using safe methods of contraception Signing the informed consent form Having Iranian citizenship Participants should be able to read and understand informed consent, preferably having an education at a diploma or higher level. Temperatures less than or equal to 37.2 ° C, sublingual, measured by a digital thermometer Negative IgG and IgM antibody titers against COVID-19 N antigen Negative RT-PCR -test for SARS-CoV-2 IgG ELISA negative blood test against HIV Heart rate between 60 and 100 Systolic blood pressure (between 90 and 140 mm Hg), Diastolic blood pressure (between 60 and 90 mm Hg) Committing to observing the requested behavioral protocol to reduce the risk of COVID-19 Negative pregnancy test for β-hCG on the day of screening and the day of vaccination Clinical trial participants should refrain from donating blood or plasma from the first vaccination until three months after the last vaccination. Participants should not enter any other trial while in this study Expressing readiness to remain in the study for the entire study period Use one of a safe methods of contraception in men and women up to 3 months after the last dose of the vaccine 18 years 70 years Both Current acute or chronic symptomatic illness that requires ongoing medical or surgical care High-risk occupations regarding the risk of acquiring COVID-19, including medical staff, occupations with close contact with many clients Serving in compulsory military service (soldiers) in the subdivisions of the Armed Forces Breastfeeding History of receiving any research vaccine during the 30 days before the day of screening History of transfusion of any blood product or immunoglobulin within the three months before the screening day History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last four months leading up to screening day History of allergic diseases such as angioedema or anaphylactic reactions History of any allergy to drugs or vaccines History of cancer or chemotherapy in the last 5 years History of serious psychiatric illnesses History of blood disorders (Blood Dyscrasias, coagulation, platelet deficiency or disorder, etc) Having chronic obstructive pulmonary disease such as asthma and COPD, ischemic cardiovascular disease diagnosed and treated by a specialist Uncontrolled blood pressure (systolic higher than 140 and diastolic higher than 90) Uncontrolled diabetes (HbA1c higher than six or BS higher than 140) or diabetes treatment by insulin History of chronic neurological diseases (including seizures and epilepsy) Having thyroid disease or a history of thyroidectomy except for controlled hypothyroidism Any history of drug/alcohol abuse (addiction) during the last 2 years Any grade 2 or higher toxicity in the hematology or biochemistry test results performed at the time of screening History of confirmed COVID-19 Acute or chronic hepatitis B and C Receiving prophylactic drug against tuberculosis History of syncope when seeing or giving blood Having splenectomy for any reason Any close contact with a definitively infected person with COVID-19 for a maximum of two weeks before the day of receiving the first dose U07.1 COVI U07.1 COVID-19, virus identified Prevention Placebo Intervention group: Two doses of 10 micro gram vaccine injected in the deltoid muscle (IM) at 14 days interval Control group:Two doses of placebo injected in the deltoid muscle (IM) at 14 days interval Abnormal vital signs and anaphylactic reactions immediately after vaccination. Vital signs include body temperature, respiratory rate, heart rate, systolic and diastolic blood pressure before and immediately after vaccination. Timepoint: In the first three hours after each vaccine dose. Method of measurement: Sublingual temperature is measured using a digital thermometer. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured using a digital sphygmomanometer in a sitting position. Local adverse events within the first week post-vaccination including pain, tenderness, erythema and redness, and swelling and stiffness. Timepoint: In the first seven days after each vaccine dose. Method of measurement: Daily telephone contacts by the research team for seven days. Systemic adverse event within the first week post-vaccination including nausea and vomiting, diarrhea, headache, fatigue, muscle pain, and other illnesses or clinical complications. Timepoint: In the first seven days after each vaccine dose and then monthly for up to six months. Method of measurement: Telephone contacts by the research team. Serum IgG level for SARS-CoV-2 N, S1-RBD antigens. Timepoint: on days zero, second injection day, two and four weeks after second injection and at 3, 6 months after the first vaccination. Method of measurement: ELISA method. Serious Adverse Event/Reaction(SAEs) , Suspected Unexpected Serious Adverse Reaction (SUSARs), Medically Attended Adverse Events (MAAEs). Timepoint: Up to six months after the last dose of the vaccine. Method of measurement: Monthly follow-up by the research team. Occurrence of COVID-19 disease. Timepoint: Two weeks after the second dose of the vaccine to study end. Method of measurement: PCR test. Neutralizing antibody activity. Timepoint: on days zero, second injection day, two and four weeks after second injection and at 3, 6 months after the first vaccination. Method of measurement: Conventional SARS-CoV-2 virus neutralizing antibody test using a biosafety level III. Cell-mediated immunity and safety of the immune response. Timepoint: on days zero, second injection day, two weeks after second injection and at 3, 6 months after the first vaccination. Method of measurement: Absolute measurement of lymphocyte cell subpopulations (B, T, NK) and their ratio, measurement of T cell subpopulations (CD3 + CD4 +, CD3 + CD8 +), measurement of TNF-a and interleukins 4, 5, 2, 17, 6, 12, 17A, 17F, 21, 8 and 10. Abnormal laboratory findings including Hemoglobin, WBC, Lymphocytes cell, Neutrophils, Eosinophils, Platelets, ESR, CRP, LDH, CPK, RT-PCR for SARS-CoV-2, Sodium, Potassium, BUN , Creatinine, Alkaline phosphatase, ALT, AST, Bilirubin (total), U/A, Urine protein, Urine glucose, Urine RBC, IL-6. Timepoint: Seven days after each vaccination, IL-6 will be measured at day zero as well. Method of measurement: Each test will be performed using the appropriate kit. Organization of Defensive Innovation and Research Approved 2021-06-07 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)