Respiratory Distress Syndrome due to SARS-CoV-2. ICD-10COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group1: One dose of FAKHRAVAC vaccine injected in the deltoid muscle (IM) Intervention. Intervention 2: Intervention group2: One dose of Sinopharm vaccine injected in the
Sponsors
Organization of Defensive Innovation and Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age more than18; Not having COVID 19 since the last dose of primary vaccination with Sinopharm; Fully vaccinated and within the 75 to 195 days post vaccination period; Signing the 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.
Exclusion criteria
Exclusion criteria: History of allergy to drugs or vaccines (e.g urticaria and fever); Current acute or chronic symptomatic illness that requires ongoing medical or surgical care; History of severe cardiovascular disease; Lactation; History of receiving any vaccine during the 14 days period prior to the day of receiving booster dose; History of transfusion of any blood product or immunoglobulin within the 3 months period before receiving booster dose; History of diseases resulting in immunosuppression (suspected and definite); History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last 4 months period leading up to the screening day; History of diagnosis or treatment for cancer (except basal cell carcinoma and Insitu cervical cancer); History of uncontrolled serious psychiatric illnesses; History of blood disorders (Blood Dyscrasias, coagulation disorders, platelet deficiency, etc); History of chronic neurological diseases (including seizure and epilepsy); Current drug/alcohol abuse (addiction); Acute febrile illness at the time of booster vaccine injection; Having splenectomy for any reason; Any close contact with a definitively infected person with COVID-19 within the two weeks period before the day of receiving the booster dose; Current 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 as prophylaxis is allowed; Chronic unstable disease (last 4 weeks) at the discretion of the principal investigator; Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Abnormal vital signs and anaphylactic reactions immediately after vaccination. Timepoint: In the first half an hour after the booster dose. Method of measurement: Temperature is measured using a digital thermometer. Respiratory rate will be counted by the research staff over one minute. Blood pressure and heart rate will be measured by a digital sphygmomanometer in a sitting position.;Local adverse reactions within the first week after booster dose. Timepoint: Daily, within the first week after the 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.;Systemic adverse reactions within the first week after booster dose. 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 systemic adverse reaction form on their behalf.;SAEs, SUSARs, MAAEs, up to 1 month after the booster dose. Timepoint: Up to one month after the booster dose. Method of measurement: Via mobile application. There will be a 24-7 followup center with physicians available all the time.;Serum ELISA IgG level for SARS-CoV-2 N, S1-RBD antigens. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose vaccine. Method of measurement: ELISA method. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohsen ForughiZadeh Moghadam
Malek Ashtar University
Outcome results
None listed