COVID-19 disease. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group 2: 5 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and 28, which is received intramuscularly (deltoid muscle). Intervention 2: Control group: The place
Sponsors
Shifa Pharmed Industrial Co.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Aged 18 to 75 years Being able to fully understand the study processes and understand the explanations of the facilitators correctly 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 the researchers to access medical records and test results if hospitalized due to suspected, or confirmed COVID-19 Using effective methods of contraception during the study at least two months after the second dose of vaccine Volunteers who agree not to donate blood, blood products, or bone marrow from the start of the vaccine until 21 days after receiving the last dose of the vaccine
Exclusion criteria
Exclusion criteria: Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days History of SARS-CoV-2 infection (Only in immunogenicity subsample Fever or at least two of these symptoms: Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, dyspnea, and shortness of breath during the 14 days prior to vaccination History of severe allergic reaction to vaccination or allergic reactions to Inactivated vaccine components Known case of tuberculosis, hepatitis B or hepatitis C History of coagulopathy History of splenectomy Uncontrolled hypertension, uncontrolled diabetes, uncontrolled chronic cardiac, renal, neurologic, or severe pulmonary disease Acute diseases or an exacerbation of a chronic disease in the last 7 days Any malignancy, immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases Receiving immunomodulators or immunosuppressors at least 14 days in the past 3 months or planning to use in the next year Receiving live vaccine in one month or other vaccines in 14 days before inoculation History of drug or alcohol abuse in the last 12 months caused medical, familial or occupational problems Receiving immunoglobulins or blood products in 3 months before inoculation or planning to use in the next year Receiving any other investigational drug in 6 months before inoculation Having a plan to participate in a drug trial during the study period Planning to receive any vaccination in on month after inoculation History of severe mental disorders affecting the participation in the study Pregnant or lactating women or those who intend to become pregnant during the study period History of travel abroad in the last 14 days Any other condition that makes a person inappropriate for participation based on the investigator opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine efficacy of Shifa-pharmed inactivated SARS-COV-2 vaccine. Timepoint: 14 to 180 days after the last dose of intervention. Method of measurement: Comparing confirmed COVID-19 cases.;Neutralizing antibody (phase 2). Timepoint: Day 0 of vaccination and 14, 28, 42, 90,180 and 360 days after the second dose. Method of measurement: Virus neutralization test.;Anti SARS-COV-2 antibody titer (IgG, IgM) (Geometric mean titer) (phase 2). Timepoint: Day 0 of vaccination and 14, 28, 42, 90,180 and 360 days after the second dose. Method of measurement: ELISA.;Severe COVID-19 cases. Timepoint: Days 14 to 180 after second dose. Method of measurement: Comparing confirmed severe COVID-19 cases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine efficacy of Shifa-pharmed inactivated SARS-COV-2 vaccine. Timepoint: From 181 to 360 days after receiving the last dose of intervention. Method of measurement: comparing confirmed COVID-19 case.;Severe COVID-19 cases. Timepoint: 181 to 360 days after second dose. Method of measurement: Comparing confirmed severe COVID-19 cases.;Any immediate reaction after inoculation. Timepoint: 0-30 minute after inoculation. Method of measurement: Close observation.;Local reactions (pain, redness, swelling, ....) in injection site. Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Systemic events (fever, headache, chills, vomiting, diarrhea, fatigues, muscle pain, joint pain, ....). Timepoint: Days 0 to 28 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Occurrence of any serious adverse event. Timepoint: Days 0 to day 360 after second dose. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Single dose efficacy of Shifa-pharmed inactivated SARS-COV-2 vaccine. Timepoint: day 1 after first doe to second dose. Method of measurement: Confirmed COVID-19 cases. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadreza Hosseinpour
Shifa Pharmed Industrial Co.
Outcome results
None listed