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

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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Biological: COVID-19 mRNA vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Lao People's Democratic Republic
  • Vientiane, Lao People's Democratic Republic, 01000
    • Mayfong Mayxay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose group with mRNA vaccine; 25μg with COVID-19 mRNA vaccine	Biological: COVID-19 mRNA vaccine; Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval
Placebo Comparator: Low dose group with placebo	Biological: COVID-19 mRNA vaccine; Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval
Experimental: High dose group with mRNA vaccine; 45μg with COVID-19 mRNA vaccine	Biological: COVID-19 mRNA vaccine; Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval
Placebo Comparator: High dose group with placebo	Biological: COVID-19 mRNA vaccine; Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local/systemic solicited adverse reaction/events	The incidence of local/systemic solicited adverse reaction/events	up to 6 days after each dose
unsolicited adverse events	The incidence of unsolicited adverse events	up to 21 days and up to 28 days after the first and second dose of immunization, respectively
The incidence of SAE	The incidence of SAE from the first dose of vaccination to 28 days after the full course of immunization	up to 28 days after the full course of immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 in the subjects who take two doses as protocol specified	14 days after the full immunization
The incidence of SAE	The incidence of SAE within the 29th ~365th day after the full course of immunization	the 29th ~365th day after the full course of immunization
Changes in laboratory abnormal parameters	Changes in laboratory abnormal parameters in the participants who take at least of one dose	after at least of one dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The positive conversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody), neutralizing antibody	The positive conversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody), neutralizing antibody before 1st and 2nd immunization, 90, 180, 365 days after the full immunization	before 1st and 2nd immunization, 90, 180, 365 days after the full immunization
Cellular immunity INF-γ, IL-4 and IL-2	Cellular immunity (INF-γ, IL-4 and IL-2) before 1st and 2nd immunization, and 14, 90, 180, 365 days after the full immunization	before 1st and 2nd immunization, and 14, 90, 180, 365 days after the full immunization

Collaborators and Investigators

• Sponsor: Stemirna Therapeutics
• Investigators: Principal Investigator: Mayfong Mayxay, professor, Mahosot Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): August 28, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SWC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No