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

NCT05144139 | Completed Phase 1 DMC

• 1 other identifier: SWC002
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Other Outcomes (2)

• 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

• Cellular immunity INF-γ, IL-4 and IL-2

  before 1st and 2nd immunization, and 14, 90, 180, 365 days after the full immunization

Study Arms (4)

Low dose group with mRNA vaccine

EXPERIMENTAL

25μg with COVID-19 mRNA vaccine

Biological: COVID-19 mRNA vaccine

Low dose group with placebo

PLACEBO COMPARATOR

Low dose group with placebo

Biological: COVID-19 mRNA vaccine

High dose group with mRNA vaccine

EXPERIMENTAL

45μg with COVID-19 mRNA vaccine

Biological: COVID-19 mRNA vaccine

High dose group with placebo

PLACEBO COMPARATOR

High dose group with placebo

Biological: COVID-19 mRNA vaccine

Interventions

COVID-19 mRNA vaccine BIOLOGICAL

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

High dose group with mRNA vaccine; High dose group with placebo; Low dose group with mRNA vaccine; Low dose group with placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stemirna Therapeutics: lead

Study Sites (1)

Mayfong Mayxay

Vientiane, 01000, Laos

Location

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mayfong Mayxay, professor

  Mahosot Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 3, 2021
• Study Start: December 3, 2021
• Primary Completion: August 28, 2022
• Study Completion: November 11, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)