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IRCT20210206050259N3 IRCT 2021-08-29 Organization of Defensive Innovation and Research Comparison of the safety and efficacy of Fakhravac and Sinopharm SARS-CoV-2 vaccines, in adults aged 18 and over Comparison of the safety and efficacy of Fakhravac and Sinopharm SARS-CoV-2 vaccines, in adults aged 18 and over; a phase III randomized, non-inferiority clinical trial 2021-09-01 anticipated 41128 Complete https://irct.ir/trial/57980 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In addition to the randomized arms, two non-randomised and open label arms were added to the study. Participants will receive one of the FAKHRAVAC or Sinofarm vaccines by their own choice in these additional arms, Randomization description: This study uses both randomized and non-randomized arms. Block randomization method with variable block sizes of 4 and 6 in STATA will be used to create the random sequence in randomized arms. For the purpose of concealment, a unique code will be assigned to each intervention the participants receive, and all subjects will be identified with this code until the end of the study (concealment code), Blinding description: In this study, the control group will receive the Sinopharm vaccine, which has different packaging (volume 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. Non-randomized arms that were added to the study later on, are not blind. 3 Respiratory Distress Syndrome due to SARS-CoV-2. Intervention 1: Intervention group: Two doses of 10 micro gram vaccine injected in the deltoid muscle (IM) at 21 days interval. Intervention 2: Control group: Two doses of Sinopharm vaccine injected in the deltoid muscle (IM) at 21 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. 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) Iran (Islamic Republic of) Age > 18; Having Iranian citizenship; Internet and smart mobile access (him/herself or one of him/his family); Living in and around the city where the trial takes place; No current COVID-19 disease; No pregnancy; Using safe methods of contraception; Signing the informed consent form. 18 years no limit Both Current acute or chronic symptomatic illness that requires ongoing medical or surgical care; Acute febrile illness; Lactation; History of receiving COVID19 vaccine; History of transfusion of any blood product or immunoglobulin within the 3 months before the study; History of long-term use (14 successive days) of immunosuppressive drugs or systemic corticosteroids in the last 4 months leading up to the study; History of diagnosis or treatment for HIV; History of allergic diseases such as angioedema or anaphylactic reactions following the use of drugs, vaccines or food; 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); Continued 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.; Current drug or alcohol abuse (addiction); Close contact with a definite case of COVID-19 up to two weeks prior to the day of receiving the first dose; Chronic diseases that are not listed as exclusion criteria but are considered unstable within the last 4 weeks. U07.1 COVID-19, virus identified Prevention Prevention Intervention group: Two doses of 10 micro gram vaccine injected in the deltoid muscle (IM) at 21 days interval Control group: Two doses of Sinopharm vaccine injected in the deltoid muscle (IM) at 21 days interval Occurrence of confirmed symptomatic Covid-19 disease two weeks after the second vaccine dose. Timepoint: Two weeks after the second dose of the vaccine up to 6 months. Method of measurement: Clinical assessments and PCR test. Occurrence of confirmed moderate, or severe illness or death due to Covid-19 infection two weeks after the second vaccine dose. Timepoint: Two weeks after the second vaccine dose up to 6 months. Method of measurement: Clinical assessments and PCR test. Occurrence of confirmed severe cases or death due to Covid-19 infection two weeks after the second vaccine dose. Timepoint: Two weeks after the second vaccine dose up to 6 months. Method of measurement: Clinical assessments and PCR test. Abnormal vital signs and anaphylactic reactions immediately after vaccination. Timepoint: In the first half an hour after each vaccine 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 events within the first week post-vaccination. Timepoint: For the first 6 days after each vaccine dose. Method of measurement: Record daily symptoms using a mobile phone application. Systemic adverse event within the first week post-vaccination. Timepoint: For the first 6 days after each vaccine dose. Method of measurement: Record daily symptoms using a mobile phone application. 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: adverse events will be assessed monthly up to 6 months. Organization of Defensive Innovation and Research Approved 2021-08-24 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)