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IRCT20201214049709N4 IRCT 2021-11-29 Razi Vaccine and Serum Research Institute Comparison of immunogenicity and safety of Razi Cov Pars and ‎Sinopharm booster doses Comparison of immunogenicity and safety of Razi Cov Pars and Sinopharm booster doses in adults 18 years of age and older who have primarily vaccinated with Sinopharm: a ‎parallel ‎‏2‏‎ arms, ‎randomised, double blind clinical trial ‎ 2021-11-30 anticipated 500 Complete https://irct.ir/trial/59902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Alongside the main study, four additional groups of participants, 25 each, who have been primarily vaccinated by either of Astrazeneca, Sputnik V, Razi CoV Pars, and Pastocovac vaccines within the last 4 to 6 month, will receive one dose of Razi CoV Pars, 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 Razi Cov Pars. 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 SARS-CoV-2. Intervention 1: Intervention group 1: Participants in this group will receive one doses (IM) of RAZI recombinant spike protein vaccine (day 0). Intervention 2: Intervention group 2: Participants in this group will receive one doses (IM) of Sinopharm vaccine (day 0). Yes - There is a plan to make this available What will be shared: Deidentified 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 availabe 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) Iran (Islamic Republic of) Having Iranian citizenship; Age 18 years and older; Having history of full vaccination with Sinopharm vaccine (two doses) 75 to 195 days from the last vaccination; Signing an 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); Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care; Severe cardiovascular disease; Breastfeeding; History of receiving any vaccine within 14 days before receiving the booster dose; History of diseases resulting in immunosuppression (suspected and definite); History of long-term use of immunosuppressive drugs, including history of long-term use of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) with the exception of topical steroids (more than 14 consecutive days) within the past 4 months; History of uncontrolled serious psychiatric illnesses; History of chronic neurological diseases (including seizures and epilepsy)؛ Acute febrile illness at the time of booster vaccine injection; Splenectomy for any reason; Close contact with a confirmed COVID-19 case within two weeks before the booster dose; 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 is allowed as prophylaxis; Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer; Received blood and/or any blood products and/or immunoglobulins within three months preceding the booster dose; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors); Current substance or alcohol abuse; Pregnancy based on the participant's statement and the time of the first day of the last menstrual period and negative pregnancy test (baby check) on the day of vaccination; History of COVID -19 based on laboratory or clinical evidence after primary vaccination; Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs. U07.1 COVID-19 Prevention Prevention Intervention group 1: Participants in this group will receive one doses (IM) of RAZI recombinant spike protein vaccine (day 0) Intervention group 2: Participants in this group will receive one doses (IM) of Sinopharm vaccine (day 0). 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. Serum levels of specific IgG antibodies against S1, RBD antigens. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose vaccine. Method of measurement: ELISA method. The cell-mediated immunity will be evaluated by counting the number of CD3, CD4 and CD8 cells and joint calculation of CD3 and CD4 and CD3 and CD8 . IFN-γ, TNF-α, and interleukins 2, 4, 6, and 17 will also be measured. It will be will be assessed in 20 members of the selected group. Summary of the measures performed in this section are as follows: 1- Assessment of CD4 to CD8 cell proportions after stimulation of PBMC (Peripheral Blood Mononuclear Cells) by inactivated virus and recombinant spike protein using flow cytometry 2- Assessment of specific proliferation of PBMC cells stimulated by inactivated virus and recombinant spike protein using flow cytometry 3 - Assessment of TH1 and TH2 specific cellular immunity after PBMC stimulation in vaccinated individuals with recombinant spike protein to determine the levels of interferon-gamma, interleukin-4, tumor necrosis factor-alpha and interleukin 6 using ELISpot and ELISA kit. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose vaccine. Method of measurement: Immunologic lab tests. Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. 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 up to half an hour after vaccine booster dose. Timepoint: Before vaccination and half an hour after vaccination. Method of measurement: Clinical examination. The number and percentage of local adverse reaction within the first week post-vaccination (including pain, tenderness, erythema / redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity. 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 local adverse reaction form on their behalf. The number and percentage of systemic adverse reaction within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) that will be assessed based on the severity score, duration and peak intensity. Timepoint: Seven days after booster dose (Days 0-7) daily assessment. 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. Number and percentage of Severe Adverse event (SAEs), Suspected Unexpected Serious Adverse Reaction (SUSAR ) and Medically Attended Adverse Events (MAAEs) Up to one month after receiving the booster dose. Timepoint: Up to one month after the booster dose. Method of measurement: Via mobile application. There will be a 24-7 follow up center with physicians available all the time. Razi Vaccine and Serum Research Institute 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)