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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05144139
Recruitment Status : Completed
First Posted : December 3, 2021
Last Update Posted : December 28, 2022
Sponsor:
Information provided by (Responsible Party):
Stemirna Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Pandemic Biological: COVID-19 mRNA vaccine Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : December 3, 2021
Actual Primary Completion Date : August 28, 2022
Actual Study Completion Date : November 11, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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
High dose group with placebo
 Biological: COVID-19 mRNA vaccine
Intramuscular injection, COVID-19 mRNA vaccine/placebo, 21 days interval


Outcome Measures
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Primary Outcome Measures :
  1. local/systemic solicited adverse reaction/events [ Time Frame: up to 6 days after each dose ]
    The incidence of local/systemic solicited adverse reaction/events

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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 [ Time Frame: 14 days after the full immunization ]
    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

  2. The incidence of SAE [ Time Frame: the 29th ~365th day after the full course of immunization ]
    The incidence of SAE within the 29th ~365th day after the full course of immunization

  3. Changes in laboratory abnormal parameters [ Time Frame: after at least of one dose ]
    Changes in laboratory abnormal parameters in the participants who take at least of one dose


Other Outcome Measures:
  1. 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 [ Time Frame: before 1st and 2nd immunization, 90, 180, 365 days after the full immunization ]
    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

  2. Cellular immunity INF-γ, IL-4 and IL-2 [ Time Frame: before 1st and 2nd immunization, and 14, 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05144139


Locations
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Lao People's Democratic Republic
Mayfong Mayxay
Vientiane, Lao People's Democratic Republic, 01000
Sponsors and Collaborators
Stemirna Therapeutics
Investigators
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Principal Investigator: Mayfong Mayxay, professor Mahosot Hospital
More Information
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Responsible Party: Stemirna Therapeutics
ClinicalTrials.gov Identifier: NCT05144139    
Other Study ID Numbers: SWC002
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: December 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases