Phase 1 clinical trial of an inactivated COVID-19 vaccine (Shifa-Pharmed) in healthy individuals

INTERVENTION: Intervention 1: Intervention group 1: 3 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and 14, which is received intramuscularly (deltoid muscle). Intervention 2: Intervention group 2: 5 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and14, which is received intramuscularly (deltoid muscle). Intervention 3: Control group: The placebo group will receive only aluminum hydroxide adjuvant in the form of deltoid intramuscular injection on days 0 and 14. Placebo is similar to the active vaccine in shape and volume. CONDITION: COVID‐19 disease. ; COVID‐19, virus identified U07.1 PRIMARY OUTCOME: Any immediate reaction after inoculation. Timepoint: 0‐30 minute after inoculation. Method of measurement: Close observation. Incidence of any adverse event (AE). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Incidence of any serious adverse event (SAE). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Percentage of local reactions (pain, redness, swelling, ....in injection site). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Percentage of systemic events (fever, headache, chills, vomiting, diarrhea, fatigues, muscle pain, joint pain, ....). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. SECONDARY OUTCOME: Antibody‐ IgG and IgM titer (The geometric mean titer of antibody). Timepoint: Days 0, 7 , 14, 21, 28 and 90, 180, 360 (follow up period). Method of measurement: ELISA. Any adverse events (AEs or SAEs). Timepoint: From Days 7 to 28 after inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Cytokine assay (including IL 1, 2,4,5,6,8,10,12,17A,17F,21IFN‐ gamma, TNF ‐ alpha). Timepoint: Days 0, 14 and 28 after inoculation. Method of measurement: ELISA. Lymphocytes subset count (Including CD3+, 4+, 8+, NK cell, B cell, ...). Timepoint: Days 0, 14 and 28 after inoculation. Method of measurement: Flow Cytometry. Neutralizing antibody activity. Timepoint: Days 0, 7 , 14, 21, 28 and 90, 180, 360 (follow up period). Method of measurement: ELISA. Percentage of seroconversion occurrence. Timepoint: Days 0, 7 , 14, 21, 28, 90, 180, 360. Method of measurement: At least a 4‐fold increase in antibody titer (IgG and IgM) above baseline : ELISA assay. The severity of SARS‐COV‐2 infection (if present). Timepoint: Any time after inoculation: days 0 to 28. Method of measurement: Clinical grading. INCLUSION CRITERIA: Aged 18 to 50 years Healthy general condition according to medical history and initial medical examinations Willing and able to cooperate throughout the study period according to the study protocol Being able to fully understand the study processes and understand the explanations of the facilitators correctly Being able to understand the contents of the informed consent form and sign it before entering the study Allowing researchers access to medical records, test results if hospitalized due to suspicion, or approval of COVID‐19 A negative pregnancy test at screening or vaccination (women only) Using effective methods of contraception during the study (male and female) Volunteers who agree not to donate blood, blood products, or bone marrow from the start of the vaccine until three months after receiving the last dose