Comparison of immunogenicity and safety of Razi Cov Pars and ?Sinopharm booster doses

INTERVENTION: 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). CONDITION: SARS‐CoV‐2. ; COVID‐19 U07.1 PRIMARY OUTCOME: 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. INCLUSION CRITERIA: 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. SECONDARY OUTCOME: 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. 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. 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‐?, TNF‐a, 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. 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.