A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above

NCT ID: NCT05144139

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2022-11-11

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.

Conditions

COVID-19 Pandemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Low dose group with mRNA vaccine

25μg with COVID-19 mRNA vaccine

Group Type: EXPERIMENTAL

COVID-19 mRNA vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval

Low dose group with placebo

Low dose group with placebo

Group Type: PLACEBO_COMPARATOR

COVID-19 mRNA vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval

High dose group with mRNA vaccine

45μg with COVID-19 mRNA vaccine

Group Type: EXPERIMENTAL

COVID-19 mRNA vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval

High dose group with placebo

High dose group with placebo

Group Type: PLACEBO_COMPARATOR

COVID-19 mRNA vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval

Interventions

COVID-19 mRNA vaccine

Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval

Intervention Type: BIOLOGICAL

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;
• Abnormal coagulation function (such as lack of coagulation factor, coagulation disorders);
• Receiving anti-tuberculosis treatment;
• Long-term receipt (continuous≥7 days) of glucocorticoid (reverence value for dose: amount to≥20 mg/d prednisone equivalent), except inhaled, topical, nasal, aural and ophthalmic corticosteroids, within 6 months before screening; Receipt of immunotherapy or immunosuppressant within 3 months (continuous oral or infusion for more than 14 days);
• Receipt of live attenuated vaccine within 28 days prior to vaccination and other vaccines within 14 days prior to vaccination;
• Receipt of blood products within 3 months prior to vaccination
• Receipt of other study drugs within 6 months prior to vaccination;
• Receipt of any SARS-COV-2 vaccine;
• Other situations judged by the investigators that are not suitable for participating in this clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stemirna Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mayfong Mayxay, professor

Role: PRINCIPAL_INVESTIGATOR

Mahosot Hospital

Locations

Mayfong Mayxay

Vientiane, , Laos

Countries

Laos

Other Identifiers

SWC002

Identifier Type: -

Identifier Source: org_study_id