Trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC)

Phase 2

Conditions: SARS-CoV-2.
U07.1 COVID-19, virus identified
U07.1 COVI

Registration Number: IRCT20210206050259N2

Lead Sponsor: Organization of Defensive Innovation and Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 500

Inclusion Criteria

Age 18 to 70 years
Body mass index between 18 and 35 kg per square meter
No current or previous COVID-19 disease
No pregnancy
Using safe methods of contraception
Signing the informed consent form
Having Iranian citizenship
Participants should be able to read and understand informed consent, preferably having an education at a diploma or higher level.
Temperatures less than or equal to 37.2 ° C, sublingual, measured by a digital thermometer
Negative IgG and IgM antibody titers against COVID-19 N antigen
Negative RT-PCR -test for SARS-CoV-2
IgG ELISA negative blood test against HIV
Heart rate between 60 and 100
Systolic blood pressure (between 90 and 140 mm Hg), Diastolic blood pressure (between 60 and 90 mm Hg)
Committing to observing the requested behavioral protocol to reduce the risk of COVID-19
Negative pregnancy test for ß-hCG on the day of screening and the day of vaccination
Clinical trial participants should refrain from donating blood or plasma from the first vaccination until three months after the last vaccination.
Participants should not enter any other trial while in this study
Expressing readiness to remain in the study for the entire study period
Use one of a safe methods of contraception in men and women up to 3 months after the last dose of the vaccine

Exclusion Criteria

Current acute or chronic symptomatic illness that requires ongoing medical or surgical care
High-risk occupations regarding the risk of acquiring COVID-19, including medical staff, occupations with close contact with many clients
Serving in compulsory military service (soldiers) in the subdivisions of the Armed Forces
Breastfeeding
History of receiving any research vaccine during the 30 days before the day of screening
History of transfusion of any blood product or immunoglobulin within the three months before the screening day
History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last four months leading up to screening day
History of allergic diseases such as angioedema or anaphylactic reactions
History of any allergy to drugs or vaccines
History of cancer or chemotherapy in the last 5 years
History of serious psychiatric illnesses
History of blood disorders (Blood Dyscrasias, coagulation, platelet deficiency or disorder, etc)
Having chronic obstructive pulmonary disease such as asthma and COPD, ischemic cardiovascular disease diagnosed and treated by a specialist
Uncontrolled blood pressure (systolic higher than 140 and diastolic higher than 90)
Uncontrolled diabetes (HbA1c higher than six or BS higher than 140) or diabetes treatment by insulin
History of chronic neurological diseases (including seizures and epilepsy)
Having thyroid disease or a history of thyroidectomy except for controlled hypothyroidism
Any history of drug/alcohol abuse (addiction) during the last 2 years
Any grade 2 or higher toxicity in the hematology or biochemistry test results performed at the time of screening
History of confirmed COVID-19
Acute or chronic hepatitis B and C
Receiving prophylactic drug against tuberculosis
History of syncope when seeing or giving blood
Having splenectomy for any reason
Any close contact with a definitively infected person with COVID-19 for a maximum of two weeks before the day of receiving the first dose