Safety, immunogenicity and dose finding for inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC)

Phase 1

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

• Registration Number: IRCT20210206050259N1
• Lead Sponsor: Organization of Defensive Innovation and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Iranian citizenship, and residing at a distance of 40-50 km from the study center
The ability of participants to study and understand informed consent, preferably educational level of high school and higher
Age between 18 and 55 years
Body mass index between 18 and 35 kg/m2
Being healthy based on clinical and laboratory examinations
Temperature 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 COVID-19
Negative ELISA test for anti-HIV IgG
Heart rate between 60 and 100
Systolic blood pressure between 90 and 140 mm Hg, diastolic blood pressure between 60 and 90 mm Hg
Signing informed consent
Accepting commitments to reduce the risk of COVID-19 infection in daily life
Not pregnant
Negative ß-hCG pregnancy test on the screening and vaccination days
The use of at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years
Willingness to continue using at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years up to three months after the second vaccine dose
Participants in the clinical trial should refrain from donating blood or plasma from the time of the first vaccine dose until three months after the second vaccine dose
should not participate in another trial during the study period
Expressing readiness to remain in the study for the entire study period
Married men should use safe methods of contraception up to three months after the second vaccine dose

Exclusion Criteria

Any acute or chronic symptomatic disease requiring ongoing medical or surgical care at the screening day
Healthcare workers
Breastfeeding
History of receiving any vaccine (whether investigational or non-investigational) within 30 days prior to the screening day
History of receiving other investigational drugs within 60 days prior to the screening day
History of receiving blood or any blood product or immunoglobulin within three months prior to the screening day
History of Immunodeficiency disorders (suspected or definite)
History of long-term use of immunosuppressive drugs (more than 14 consecutive days) within four months prior to the screening day
History of long-term use (more than 14 consecutive days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) or high-dose inhaled steroids (more than 800 µg/day of beclomethasone dipropionate or equivalent) within four months prior to the screening day (excluding topical steroids)
History of allergic diseases such as angioedema or anaphylaxis
History of any known allergy to drugs or vaccines including aluminum phosphate and albumin
History of known allergy to eggs
History of autoimmune diseases
Chemotherapy or radiotherapy in the last 5 years
History of cancer in the last 5 years
History of serious psychiatric illnesses
History of blood disorders (dyscrasia, coagulation disorders, platelet deficiency or disorder, deficiency of blood factors)
History of chronic obstructive pulmonary disease such as asthma diagnosed by a specialist
History of ischemic heart disease currently treated by a cardiologist or receiving any cardiac interventions
History of hypertension currently treated by a physician
History of diabetes currently treated by a physician
Congenital anomalies, growth retardation, genetic defects or severe malnutrition
Individual or family history of chronic neurological diseases (including seizures and epilepsy)
History of thyroid disease or Thyroidectomy
Any history of substance or alcohol abuse in the past 2 years
Abnormal hematological or biochemical test results at the time of screening
History of confirmed COVID-19
Acute febrile illness at the time of vaccination
History of allergy to acetaminophen
History of acute or chronic hepatitis B and C
History of pulmonary or extrapulmonary tuberculosis or receiving antituberculotic treatment
Receiving tuberculosis prophylaxis
History of faint in any encounter with needles or phlebectomy
Splenectomy for any reason or history of abnormal spleen function
Any close contact with a confirmed COVID-19 case up to two weeks before receiving the first vaccine dose
Previous history of diseases such as SARS and MERS
Not fit to participate in the trial (the decision is at the discretion of the chief investigator)
People who are currently serving their obligatory military service in the Armed Forces

Study & Design

• Study Type: interventional
• Study Design: Not specified