A Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity and Immune Persistence of COVID-19 mRNA Vaccine in Healthy People Aged 18 Years and Above.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 Pandemic
- Sponsor
- Stemirna Therapeutics
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- unsolicited adverse events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above.
Detailed Description
This is the clinical trial including an open-label, single-arm Phase I study and a subsequent randomized, blind, placebo-parallel controlled Phase II study to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18-60 years and ≥18 years respectively, whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •People aged 18-60 years (both inclusive) for phase 1 and aged ≥18 years for phase 2；
- •Medical history and physical examination indicating as a healthy person;
- •The female participant or the spouse (or partner) of the male participant in child-birthing age agrees to use effective contraceptive measure throughout the whole course of this clinical trial.
- •Those who are participating in this clinical trial voluntarily, have signed the informed consent form, and been able to understand and comply with the requirements of the clinical trial protocol.
Exclusion Criteria
- •Confirmed cases or history of SARS-CoV-2 infection;
- •Has a history of SARS and MERS virus infection;
- •Has fever (axillary temperature ≥37.3℃), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before vaccination;
- •Positive urine pregnancy test；
- •Axillary temperature ≥37.3℃ at the day vaccinated;
- •History of severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurosis, edema, etc.) or allergies to known components of COVID-19 mRNA vaccine;
- •History or family history of convulsions, epilepsy, encephalopathy, or mental illness;
- •Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •Known suffering from diseases including: acute respiratory disease (such as flu-like illness, acute cough, sore throat), severe cardiovascular disease, kidney disease, uncontrolled hypertension (systolic blood pressure \>150 mmHg, diastolic blood pressure \>90 mmHg), diabetes complications, malignant tumor, all sorts of acute illness or chronic diseases acute phase;
- •Diagnosis with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune disease;
Outcomes
Primary Outcomes
unsolicited adverse events
Time Frame: up to 21 days and up to 28 days after the first and second dose of immunization, respectively
The incidence of unsolicited adverse events
The incidence of SAE
Time Frame: up to 28 days after the full course of immunization
The incidence of SAE from the first dose of vaccination to 28 days after the full course of immunization
local/systemic solicited adverse reaction/events
Time Frame: up to 6 days after each dose
The incidence of local/systemic solicited adverse reaction/events
Secondary Outcomes
- The seroconversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody) and neutralizing antibody(14 days after the full immunization)
- The incidence of SAE(the 29th ~365th day after the full course of immunization)
- Changes in laboratory abnormal parameters(after at least of one dose)