IRCT20210206050259N1
Completed
Phase 1
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
Organization of Defensive Innovation and Research0 sites135 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- SARS-CoV-2.
- Sponsor
- Organization of Defensive Innovation and Research
- Enrollment
- 135
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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