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IRCT20210206050259N4 IRCT 2021-11-29 Organization of Defensive Innovation and Research Comparison of safety and immunogenicity of FAKHRAVAC and Sinopharm booster doses for adults 18 years of age and older, fully vaccinated by Sinopharm Comparison of safety and immunogenicity of FAKHRAVAC and Sinopharm booster doses for adults 18 years of age and older, fully vaccinated by Sinopharm: a ‎parallel ‎‏2‏‎ arms, ‎randomised, double blind clinical trial 2021-12-01 anticipated 400 Complete https://irct.ir/trial/59912 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, stratified block randomization method with block size of 4 was used to assign each participant to the intervention groups. The rand() function of Excel software were used to generate random sequence within each block. After determining the allocated intervention, a non-repetitive five-digit random code was assigned to each participant, Blinding description: In this study, the control group will receive the Sinopharm vaccine, which has different packaging and shape compared to FakhraVac. Therefore, implementation of blinding will be done by a person who will be responsible for this. This is the only person who will not be blind to the intervention given. Once the participant becomes eligible to receive the vaccine, a concealment/randomization code will be assigned to the volunteer and the vaccine type will be displayed on the screen of the vaccinator until the inoculation is confirmed. N/A Respiratory Distress Syndrome due to SARS-CoV-2. Intervention 1: Intervention group1: One dose of FAKHRAVAC vaccine injected in the deltoid muscle (IM) Intervention. Intervention 2: Intervention group2: One dose of Sinopharm vaccine injected in the deltoid muscle (IM). 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. A scientific Advisory committee to MILAD Daru Nour Co should confirm necessity and scientific validity of the proposed joint project 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
Malek Ashtar University, Shabanloo St., Lavizan
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 more than18; Not having COVID 19 since the last dose of primary vaccination with Sinopharm; Fully vaccinated and within the 75 to 195 days post vaccination period; Signing the informed consent form; For females of childbearing age 18 to 49 years: use of at least one effective method of contraception (condom, oral contraceptive pills, intrauterine device, norplant capsule) and willing to continue up to two month after the booster dose. 18 years no limit Both History of allergy to drugs or vaccines (e.g urticaria and fever); Current acute or chronic symptomatic illness that requires ongoing medical or surgical care; History of severe cardiovascular disease; Lactation; History of receiving any vaccine during the 14 days period prior to the day of receiving booster dose; History of transfusion of any blood product or immunoglobulin within the 3 months period before receiving booster dose; History of diseases resulting in immunosuppression (suspected and definite); History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last 4 months period leading up to the screening day; History of diagnosis or treatment for cancer (except basal cell carcinoma and Insitu cervical cancer); History of uncontrolled serious psychiatric illnesses; History of blood disorders (Blood Dyscrasias, coagulation disorders, platelet deficiency, etc); History of chronic neurological diseases (including seizure and epilepsy); Current drug/alcohol abuse (addiction); Acute febrile illness at the time of booster vaccine injection; Having splenectomy for any reason; Any close contact with a definitively infected person with COVID-19 within the two weeks period before the day of receiving the booster dose; Current use of anticoagulants such as coumarin and related anticoagulants (such as warfarin) or new oral anticoagulants / antiplatelet agents. Note: Less than 325 mg of aspirin per day as prophylaxis is allowed; Chronic unstable disease (last 4 weeks) at the discretion of the principal investigator; Pregnancy. U07.1 ICD-10COVID-19, virus identified Prevention Prevention Intervention group1: One dose of FAKHRAVAC vaccine injected in the deltoid muscle (IM) Intervention Intervention group2: One dose of Sinopharm vaccine injected in the deltoid muscle (IM) Neutralizing antibody activity. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose injection. Method of measurement: SARS-CoV-2 virus neutralizing antibody titter measured in bio-safety level III lab using conventional method. Abnormal vital signs and anaphylactic reactions immediately after vaccination. Timepoint: In the first half an hour after the booster dose. Method of measurement: Temperature is measured using a digital thermometer. Respiratory rate will be counted by the research staff over one minute. Blood pressure and heart rate will be measured by a digital sphygmomanometer in a sitting position. Local adverse reactions within the first week after booster dose. Timepoint: Daily, within the first week after the booster dose. Method of measurement: Via mobile application, study staff will contact participants who fail to fill their application and complete a local adverse reaction form on their behalf. Systemic adverse reactions within the first week after booster dose. Timepoint: Daily, within the first week after booster dose. Method of measurement: Via mobile application, study staff will contact participants who fail to fill their application and complete a systemic adverse reaction form on their behalf. SAEs, SUSARs, MAAEs, up to 1 month after the booster dose. Timepoint: Up to one month after the booster dose. Method of measurement: Via mobile application. There will be a 24-7 followup center with physicians available all the time. Serum ELISA IgG level for SARS-CoV-2 N, S1-RBD antigens. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose vaccine. Method of measurement: ELISA method. Organization of Defensive Innovation and Research Approved 2021-11-28 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)