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

SARS-CoV-2 Clinical Trial

Official title:

Phase Ⅱ Clinical Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) in Chinese People Aged 18~59 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352867
• Other study ID #: LVRNA009-?-01
• Status: Completed
• Phase: Phase 2
• Start date: March 16, 2022
• Est. completion date: June 21, 2023

Study information

• Verified date: September 2023
• Source: AIM Vaccine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 21, 2023
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

1. The age at the time of the first dose of the vaccine is 18-59 years old, and the gender is not limited;

2. The subject has full capacity for civil conduct;

3. Axillary body temperature is less than 37.3 ? on the day of enrollment;

4. 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:

1. 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;

2. Have a history of severe allergies to any vaccines, foods, and drugs, such as urticaria, anaphylactic shock, skin eczema, allergic dyspnea, angioedema, etc.;

3. 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);

4. Have a history of SARS virus infection;

5. Those with a medical history or family history of epileptic convulsions or convulsions, neurological diseases and mental diseases;

6. There is a history of thrombocytopenia or other coagulation disorders diagnosed by the hospital before enrollment;

7. 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);

8. 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;

9. Those with known immunological impairment or low function diagnosed by the hospital before enrollment;

10. There is evidence that he is a smoker, alcohol abuser and drug abuser;

11. Positive SARS-CoV-2 nucleic acid test results and/or positive antibody test results before the first dose of vaccination;

12. 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;

13. 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;

14. 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);

15. 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.;

16. Those who have received whole blood, plasma and immune globulin treatment within 6 months before the first dose of vaccine;

17. Received other inactivated vaccines within 14 days before the first dose of vaccine, and received live attenuated vaccines within 28 days;

18. Antipyretic, analgesic and anti-allergic drugs are being used within 3 days before enrollment;

19. Subjects who, in the judgment of the investigator, cannot follow the research procedures, abide by the agreement, or plan to permanently relocate from the local area before the end of the study, or plan to leave the local area for a long time during the scheduled visit;

20. The relevant staff members involved in this research or their immediate family members (such as spouses, parents, siblings or children);

21. According to the judgment of the investigator, there are other circumstances that are not suitable for participating in this clinical trial.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• SARS-CoV-2 (LVRNA009) 50µg group
50µg/person
• SARS-CoV-2 (LVRNA009) 100µg group
100µg/person

Other:
• Placebo
0.5ml/person

Locations

Country	Name	City	State
China	Outpatient Department of Hunan Provincial Center For Disease Control And Prevention	Changsha	Hunan
China	Xiangtan Center For Disease Control And Prevention	Xiangtan	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
AIM Vaccine Co., Ltd.	Hunan Provincial Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of SARS-CoV-2 novel coronavirus S protein antibody (IgG)		28 days after full-vaccination
Primary	Level of SARS-CoV-2 novel coronavirus neutralizing antibodies		28 days after full-vaccination
Secondary	Incidence of adverse events		14 days and 28 days after each dose of vaccination
Secondary	Incidence of adverse events associated with the experimental vaccine		14 days and 28 days after each dose of vaccination
Secondary	Incidence of SAEs		28 days, 3 months, 6 months and 12 months after first vaccination to full vaccination
Secondary	Incidence of SAEs associated with the experimental vaccine		28 days, 3 months, 6 months and 12 months after first vaccination to full vaccination
Secondary	Incidence of grade =3 adverse events		28 days after each dose or full vaccination
Secondary	Incidence of grade =3 adverse events associated with the experimental vaccine		28 days after each dose or full vaccination
Secondary	Withdrawal from the trial due to adverse events		28 days after each dose or full vaccination
Secondary	Level of SARS-CoV-2 novel coronavirus S protein antibody (IgG)		14 days, 3 months, 6 months and 12 months after full vaccination
Secondary	Positive conversion rate of SARS-CoV-2 novel coronavirus S protein antibody		14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
Secondary	Level of SARS-CoV-2 novel coronavirus neutralizing antibody		14 days, 3 months, 6 months and 12 months after full vaccination
Secondary	Positive conversion rate of SARS-CoV-2 novel coronavirus neutralizing antibody		14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
Secondary	Level of specific cellular immune response against the new coronavirus (2019-nCoV) in subjects participating in cellular immune blood collection(IL-2?IL-4?IL-13?IFN-? )(ELISPOT)		7th day after full vaccination