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A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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.

NCT05144139•Stemirna Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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;
+8 more criteria

Locations (1)

Mayfong Mayxay

Vientiane, Laos

Key Dates

Start Date

December 3, 2021

Primary Completion Date

August 28, 2022

Completion Date

November 11, 2022

Last Updated

December 28, 2022

Enrollment

480

ACTUAL participants

Conditions

COVID-19 Pandemic

Interventions

COVID-19 mRNA vaccine

BIOLOGICAL

Corona Virus Disease 2019 Cohort Study

NCT06927622

COVID-19 PneumoniaCOVID-19 Pandemic+1 more

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ACTIVE_NOT_RECRUITING

Long COVID and Its Associations With Health Outcomes in Older Adults

NCT05825651

Long COVIDCOVID-19 Pandemic+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Corona Virus Disease 2019 Cohort Study

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