COVID-19 disease. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: 5 micrograms of antigen protein (Shifa Pharmed Co.) on days 0 and14, which is received intramuscularly (deltoid muscle). Intervention 2: Control group:The placebo g
Sponsors
Shifa Pharmed Industrial Co.
Eligibility
Sex/Gender
All
Age
51 Years to 75 Years
Inclusion criteria
Inclusion criteria: Aged 51 to 75 years Healthy general condition according to medical history and initial medical examinations (not an exacerbation or hospitalization due to disease in the last 3 months) 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 (in non menopause 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
Exclusion criteria
Exclusion criteria: Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline.COVID-19 positive antibody COVID-19 positive antibody History of SARS-CoV-2 infection History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days People in the home quarantine period due to COVID(suspicion of exposure or suspicious symptoms) Fever (axillary temperature greater than 37.5 ° C or oral temperature greater than 38° C) or two symptoms from: Dry cough, extreme tiredness, nasal congestion, runny nose, sore throat, muscle aches, diarrhea, dyspnea, and shortness of breath during the 14 days prior to vaccination Abnormality in biochemistry, blood and urine laboratory tests History of severe allergy or allergic reactions to Inactivated vaccine components Personal or family history of seizure, epilepsy, encephalopathy or mental disorders Congenital malformations History of neurologic disorders or seizure or Guillain-Barre syndrome (excluding childhood febrile seizure) Growth disorders Any genetic disorder History or signs of malnutrition Hepatorenal diseases Uncontrolled hypertension Diabetes complications BMI > 40 Any malignancy Acute diseases or an exacerbation of a chronic disease in the last 7 days Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases Thyroid disease or history of thyroidectomy Splenectomy or history of any organ removal History of coagulopathy Receiving Anti-TB treatment Positive HBSAg Positive HIV test Positive HCV antibody Receiving immunomodulators or immunosuppressors at least 14 days in the past 3 months Receiving live vaccine in one month or other vaccines in 14 days before inoculation History of drug or alcohol abuse Receiving immunoglobulins or blood products in 3 months before inoculation Receiving any other investigational drug in 6 months before inoculation Planning to receive any vaccination in one month after inoculation History of severe mental disorders affecting the participation in the study If not menopause: Pregnant or lactating women or those who intend to become pregnant during the study period Having a high-risk job of being exposed to the SARS-CoV-2 virus or having a high risk of exposure according to the investigator evaluation Any other condition that makes a person inappropriate for participation based on the investigator opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Systemic reaction (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.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Any adverse events (serious or non-serious). Timepoint: 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.;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.;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.;Neutralizing antibody activity. Timepoint: Days 0, 7 , 14, 21, 28 and 90, 180, 360 (follow up period). Method of measurement: Virus neutralization test (VNT).;Lymphocytes subset count (Including CD3+, 4+, 8+, NK cell, B cell, ...). Timepoint: Days 0, 14 and 28 after inoculation. Method of measurement: Flow Cytometry.;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.;The severity of SARS-COV-2 infection (if present). Timepoint: Any time after inoculation: days 0 to 28. Method of measurement: Clinical grading. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadreza Hosseinpour
Shifa Pharmed Industrial Co.
Outcome results
None listed