Clinical Trial of SARS-CoV-2 mRNA Vaccine in Chinese People

NCT05352867 | Completed Phase 2

• 1 other identifier: LVRNA009-Ⅱ-01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

Phase Ⅱ Clinical Trial to Evaluate the Safety and Immunogenicity of the New Coronavirus mRNA Vaccine (LVRNA009) in Chinese People Aged 18\~59 Years

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Level of SARS-CoV-2 novel coronavirus S protein antibody (IgG)

  28 days after full-vaccination

• Level of SARS-CoV-2 novel coronavirus neutralizing antibodies

  28 days after full-vaccination

Secondary Outcomes (12)

• Incidence of adverse events

  14 days and 28 days after each dose of vaccination

• Incidence of adverse events associated with the experimental vaccine

  14 days and 28 days after each dose of vaccination

• Incidence of SAEs

  28 days, 3 months, 6 months and 12 months after first vaccination to full vaccination

• Incidence of SAEs associated with the experimental vaccine

  28 days, 3 months, 6 months and 12 months after first vaccination to full vaccination

• Incidence of grade ≥3 adverse events

  28 days after each dose or full vaccination

Study Arms (3)

50μg group

EXPERIMENTAL

Biological: SARS-CoV-2 (LVRNA009) 50μg group

100μg group

EXPERIMENTAL

Biological: SARS-CoV-2 (LVRNA009) 100μg group

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

SARS-CoV-2 (LVRNA009) 50μg group BIOLOGICAL

50μg/person

50μg group

SARS-CoV-2 (LVRNA009) 100μg group BIOLOGICAL

100μg/person

100μg group

Placebo OTHER

0.5ml/person

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The age at the time of the first dose of the vaccine is 18-59 years old, and the gender is not limited;
• The subject has full capacity for civil conduct;
• Axillary body temperature is less than 37.3 ℃ on the day of enrollment;
• Subjects have independent judgment ability, can read, understand and complete vaccination diary cards, and they participate voluntarily and sign an informed consent form.

You may not qualify if:

• The subject has a history of contact with a person infected with SARS-CoV-2 (positive nucleic acid test) or a person suspected of being infected within 14 days;
• Have a history of severe allergies to any vaccines, foods, and drugs, such as urticaria, anaphylactic shock, skin eczema, allergic dyspnea, angioedema, etc.;
• The subject has a history of hypersensitivity to any component of the study vaccine (SARS-CoV-2 mRNA, Dlin-MC3-DMA, cholesterol, distearoylphosphatidylcholine, PEG2000-DMG, phosphate buffer);
• Have a history of SARS virus infection;
• Those with a medical history or family history of epileptic convulsions or convulsions, neurological diseases and mental diseases;
• There is a history of thrombocytopenia or other coagulation disorders diagnosed by the hospital before enrollment;
• The investigator judges that they are known or suspected to suffer from more serious diseases at the same time, including: respiratory diseases, tuberculosis, acute infection or active chronic disease, liver and kidney disease, cardiovascular disease (cardiopulmonary failure), and drug-uncontrollable hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg), malignant tumor, infection or allergic skin disease, HIV infection (test report can be provided);
• Congenital malformations, developmental disorders, or chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain-Barré syndrome) determined by the investigator to be unsuitable for participating in this research;
• Those with known immunological impairment or low function diagnosed by the hospital before enrollment;
• There is evidence that he is a smoker, alcohol abuser and drug abuser;
• Positive SARS-CoV-2 nucleic acid test results and/or positive antibody test results before the first dose of vaccination;
• Female: a person with a positive urine pregnancy test, who is pregnant, breastfeeding, or has a pregnancy plan within 1 year; male: a person whose spouse has a pregnancy plan within 1 year;
• Any other investigational or unregistered product (drug, biological product, or device) is being used before the first dose of vaccine, or is planned to be used during the study;
• Those who received immune enhancement or immunosuppressive therapy within 6 months before the first dose of vaccine (continuous oral or infusion for more than 14 days);
• Has been diagnosed with congenital or acquired immunodeficiency, or suspected of having a systemic disease that may interfere with the conduct or completion of the study, such as: tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV); ), syphilis infection, etc.;

Sponsors & Collaborators

• AIM Vaccine Co., Ltd.: lead
• Hunan Provincial Center for Disease Control and Prevention: collaborator

Study Sites (2)

Outpatient Department of Hunan Provincial Center For Disease Control And Prevention

Changsha, Hunan, 410028, China

Location

Xiangtan Center For Disease Control And Prevention

Xiangtan, Hunan, 411228, China

Location

MeSH Terms

Interventions

LVRNA009 COVID-19 vaccine; Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Tao Huang

  Hunan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: March 16, 2022
• Primary Completion: June 23, 2022
• Study Completion: June 21, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

CN (2)