Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) in Chinese People Aged 18 Years and Over

AIM Vaccine Co., Ltd.3 sites in 1 country144 target enrollmentJuly 31, 2021

ConditionsCOVID-19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: AIM Vaccine Co., Ltd.
Enrollment: 144
Locations: 3
Primary Endpoint: Incidence of adverse events associated with the experimental vaccine
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a phase I clinical trial. The investigators intent to evaluate the safety, tolerability and preliminary immunogenicity of SARS-CoV-2 mRNA vaccine (LVRNA009) in Chinese people aged 18 years and over.

Registry

clinicaltrials.gov

Start Date

July 31, 2021

End Date

October 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AIM Vaccine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age at the time of the first dose of vaccine: aged 18 to 59 years (including boundary values) in the adult group, \>=60 years old in the older group, regardless of gender;
•Axillary body temperature is less than 37.3 ℃ on the day of enrollment;
•Based on the medical history and relevant physical examination and laboratory examination results, the investigator clinically determined that the patient was in good health;
•Subjects have independent judgment ability, can read, understand and complete vaccination diary cards, and they participate voluntarily and sign an informed consent form.

Exclusion Criteria

•The subject has a history of SARS-CoV-2 infection, or has a history of contact with SARS-CoV-2 infected persons (nucleic acid test positive) or suspected infected persons within 30 days before screening, or living abroad within 30 days before screening history;
•Anyone who is allergic to any vaccines, drugs, foods or known excipients (Dlin-MC3-DMA, cholesterol, distearoylphosphatidylcholine, PEG2000-DMG);
•Have a history of SARS virus infection;
•Upon questioning, have a history of COVID-19 vaccination, or have received other inactivated vaccines within 14 days before screening, and received live attenuated vaccines within 28 days;
•Patients have a medical history or family history of epilepsy, convulsions or convulsions, neurological diseases and mental diseases;
•There are contraindications for intramuscular injection, such as: thrombocytopenia that has been diagnosed, any coagulation disorder or receiving anticoagulant treatment, etc.;
•The investigator judges that he is known or suspected of having more serious diseases at the same time, including but not limited to: respiratory diseases (tuberculosis, lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), Malignant tumor, infection or allergic skin disease, HIV infection (test report can be provided), or during the active period of acute infection or chronic disease (within 3 days before vaccination);
•Congenital malformations, developmental disorders, or chronic diseases that the investigator judges are not suitable for participating in this study (such as Downs syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome, etc.), excluding stable diabetes/hypertension );
•Patients with known immunological impairment or low immunological function diagnosed by the hospital before enrollment, or functional asplenia or splenectomy caused by any situation;
•There is evidence that they are smokers (smokers \>=10 cigarettes/day), alcoholics (alcohol consumption \>=4 units/day), drug abusers, and those who do not agree to quit smoking or drinking during the trial;

Outcomes

Primary Outcomes

Incidence of adverse events associated with the experimental vaccine

Time Frame: 28 days after each dose or full vaccination

Incidence of adverse events associated with the experimental vaccine within 28 days after each dose or full vaccination.

Incidence of adverse events including solicited adverse event（AE） and unsolicited adverse event（AE）

Time Frame: Solicited AE -14 days post-vaccination, all adverse events other than solicited AE - 28 days after vaccination

Solicited AE--14 days post-vaccination, common reactions at the vaccination site and non-vaccination site pre-listed on the subject's diary card and electronic case report form（eCRF）, including pain, induration, swelling, rash, flushing, itching, cellulitis at injection site, fever, headache, chills, anorexia, diarrhea, nausea, vomiting, fatigue, weakness, arthralgia, acute allergic reaction, muscle pain at non-inoculation site. non-solicited AE --28 days after vaccination, all adverse events other than solicited AE and after 14 days.

Secondary Outcomes

Incidence of serious adverse event（SAE）(28 days, 3 months, 6 months and 12 months after primary immunization to full immunization)
Incidence of SAEs associated with the experiment vaccine(28 days, 3 months, 6 months and 12 months after primary immunization to full immunization)
Incidence of clinically significant abnormalities in laboratory tests(28 days after each dose or full vaccination)
Withdrawal from the trial due to adverse events(28 days after each dose or full vaccination)
Incidence of grade ≥3 adverse events associated with the experimental vaccine(28 days after each dose or full vaccination)
Incidence of grade ≥3 adverse events(28 days after each dose or full vaccination)