Phase 1, safety, immunogenicity and dose finding for two strengths of 0.5 × 10^6 and 2.5 × 10^6 (TCID50) inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) injected in two schedules of two doses, 2 and 3 weeks apart in healthy adults aged 18-55 years: a randomized, double blind, placebo controlled, clinical trial

Inclusion criteria:

Age 18 to 55 years Body mass index between 18 and 35 kg per square meter Having complete health based on clinical and laboratory criteria No current or previous COVID-19 disease No pregnancy Useing safe methods of contraception Signing the informed consent form Having Iranian citizenship Participants should be able to read and understand informed consent, preferably with a diploma or higher certificate Temperatures less than or equal to 37.2 ° C sublingually measured by an electronic 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) Accept commitments to reduce the risk of COVID-19 Negative pregnancy test for β-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 3 months after the last vaccination. Participants should not enter any other trial while in this study Expressing a person's readiness to remain among the people monitored in the study for the entire study period until the research process is completed within 14 months Use one of a safe method 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 risk of COVID-19, including medical staff, occupations with close contact with many client Serving in compulsory military service (soldiers) in the subdivisions of the Armed Forces Breastfeeding History of receiving any research vaccine during the 30 days prior to the day of screening History of transfusion of any blood product or immunoglobulin within the 3 months before the screening day History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last 4 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. high blood pressure that is being treated by a doctor. diabetes that is being treated by a doctor. History of chronic neurological diseases (including seizures and epilepsy) Any history of drug abuse (addiction) or alcohol consumption during the last 2 years Any grade 1 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 with injection or blood observation having a 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

Target sample size: 135

Actual sample size reached: 135