Phase I clinical trial of Osvid-19 inactivated vaccine for Covid-19 (Osve Pharmaceutical Company)
- Conditions
- COVID-19 disease.COVID-19, virus identifiedU07.1
- Registration Number
- IRCT20210622051670N1
- Lead Sponsor
- Osve pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Volunteers between the ages of 18 and 40 of both sexes; Ability to provide informed written consent; Volunteers who are healthy and do not have any uncontrolled underlying disease; Appropriate general health and mental health as determined by the principal investigator (including: normal vital signs, heart rate between 60 and 100 (beat/ min); systolic blood pressure =90 mm Hg and <140 mm; Diastolic blood pressure = 60 mm Hg and <90 mm Hg; oral temperature less than 37.3 ° C (temperature less than 0.37 ° C digitally), physical examination and review of medical records); Expressing interest and availability to conduct studies and visits; For female participants of childbearing age, ensuring no plan for pregnancy / using a reliable method of contraception and not planning for pregnancy at least from the time of enrollment to 4 weeks after the second dose of vaccine; Males use a safe method of prevention such as condoms at least three months after the second dose of vaccination; The male volunteer agrees not to donate sperm for three months after the second vaccine; volunteers should refrain from donating blood or plasma from the recruitment until three months after the second dose of the vaccine; Volunteers agree not to participate in another clinical trial for the duration of the study; The volunteer agrees to stay in the study area for the entire duration of the study.
Documented history of Covid-19 infection (principal investigator determines the final summary of the volunteer's history of infection by examining the set of clinical symptoms related to Covid-19 include: positive PCR test, pulmonary involvement documents, family members' history); History of participation in studies of other Covid-19 vaccines candidates; History of Covid-19 vaccine injection; Unacceptable laboratory abnormalities from screening (before the first vaccination), or immune assay, as follows: [Abnormal blood parameters (CBC), random blood sugar level, renal function, test (serum urea and creatinine) ), Liver function tests, urinalysis reports, or patients with a specific history of HIV infection; for women, positive pregnancy serum test (during screening within 45 days of enrollment); Temperatures above 37 ° C by digital thermometry and temperatures above 37.3 ° C by oral thermometry (in suspected cases) or symptoms such as upper respiratory tract infection or gastritis within three days before each Vaccine dose; Medical problems as a result of alcohol or drug use over the past 12 months.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immediate reaction after injection. Timepoint: 0-3 hours after injection. Method of measurement: Close observation/ monitoring.;Local reactions at the injection site. Timepoint: 0-7 days after injection. Method of measurement: Close observation/ monitoring.;Systemic reactions. Timepoint: 0-7 days after injection. Method of measurement: Close observation/ monitoring.;Abnormal results of laboratory findings. Timepoint: Baseline and 2 weeks after inejection. Method of measurement: Blood and urine sampling, lab tests.;Incidence of any adverse event (serious or non-serious). Timepoint: 0, 2 weeks, 4 weeks ,6 weeks, 3, 6 and 12 months. Method of measurement: Examination, history, and report of the study participant/ Medical dictionary.;Neutralizing Antibody titer/ activity. Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, 3, 6 and 12 months. Method of measurement: ELISA.
- Secondary Outcome Measures
Name Time Method Cytokines; IL2, IL4, IL5 and IL6, IFN-?, TNF-a. Timepoint: Baseline, 4 weeks, 6 weeks. Method of measurement: ELISA.;Incidence and severity of symptomatic and asymptomatic SARS-COV-2. Timepoint: Baseline, 4 weeks, 6 weeks, 3 months, 6 months, 12 months. Method of measurement: PCR, severity grading.;Seroconversion. Timepoint: Baseline, 4 weeks, 6 weeks, 3 months, 6 months, 12 months. Method of measurement: ELISA.