Official Title
Randomized, Blinded, Positive and Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) Booster Vaccination in People 18 Years of Age and Older Who Have Received SARS-CoV-2 Vaccine.
Brief Summary

This trial is a phase II clinical trial of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021).The trial was randomized, blinded, placebo controlled. To evaluate the safety andimmunogenicity of the study vaccine in participants aged 18 years and older who havereceived SARS-CoV-2 Vaccine.

Detailed Description

Not Provided

Active, not recruiting
SARS-CoV-2

Biological: SARS-CoV-2 Bivalent mRNA Vaccine

100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into
the lateral deltoid muscle of the upper arm.
Other Name: LVRNA021

Other: Saline

100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper
arm.

Eligibility Criteria

Inclusion Criteria:

1. Healthy adults aged 18 years and older, both male and female, who can provide legal
identity certificate of participants;

2. The subject understands the contents of the Informed Consent Form and the
vaccination situation of this vaccination, voluntarily signs the Informed Consent
Form, and has the ability to use the thermometer, scale and fill in the Diary Card
and Contact Card as required (if the subject is unable to sign the Informed Consent
Form by himself/herself due to limited reading and writing ability, the informed
consent form and signature of the Informed Consent Form can be completed under the
witness' s witness);

3. Able to communicate well with investigators and understand and comply with the
requirements of this trial;

4. Completion of basic immunization with SARS-CoV-2 vaccine ≥ 6 months;

5. Negative nucleic acid test for SARS-CoV-2 within 3 days prior to vaccination;

6. Women who have used effective contraception within 2 weeks prior to inclusion in
this trial, have a negative pregnancy test (pregnancy test can be exempted for those
who have been amenorrheic for at least 1 year or have a documented history of
surgical sterilization), and voluntarily agree to continue using at least 1
effective contraception within 6 months after vaccination [effective contraception
includes: oral contraceptives, injected or implanted contraception,
sustained-release local contraceptives, hormonal patches, intrauterine device (IUD),
sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.];

7. Healthy participants or participants with mild underlying disease [stable condition
without worsening (requiring no hospitalization or major modification of treatment
regimen, etc.) for at least 3 months prior to inclusion in this trial].

Exclusion Criteria:

1. Participants with abnormal electrocardiogram during screening and who were judged
unsuitable for vaccination by investigators; Blood pressure indicators during the
screening period: systolic blood pressure ≥160 or diastolic blood pressure
≥100mmHgHg, or abnormal blood pressure, and the health status determined by the
investigator is uncertain and requires further diagnosis, or the investigator
determines that the vaccination is not suitable for participants with medical
history and clinical manifestations ;

2. Body mass index (BMI) <18 kg/m 2 or >30 kg/m 2;

3. Individuals with any infectious disease, acute infection, acute phase of chronic
infection (such as active untreated pulmonary tuberculosis, etc.) or any advanced
immune disease (inquiry);

4. Infected within last 6 months or likely infected with SARS-CoV-2;

5. Positive HIV test result at screening;

6. Fever on the day of investigational vaccination (axillary temperature ≥ 37.3℃) or
within 3 days, or use of antipyretic and analgesic drugs within 3 days;

7. Women with a positive pregnancy test (surgical sterilizers who are menstruating or
amenorrheic for at least 1 year or have medical records may be exempted from
pregnancy testing), or breastfeeding women, or women planning to become pregnant
from screening through 6 months after booster vaccination, men whose partners plan
to become pregnant, or plan to donate sperm and eggs;

8. Previous history of allergic or allergic reactions to vaccines or drugs, such as
urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;

9. Administration of any vaccine within 28 days prior to booster vaccination with
investigational vaccine;

10. Have participated within 28 days prior to booster vaccination with investigational
vaccine or plan to participate in other drug clinical trials within 12 months after
booster vaccination;

11. Patients with a history of thrombocytopenia or other coagulation disorders, which
may cause contraindications to subcutaneous blood sampling or injection, and
patients with a history of thrombosis;

12. Known history or diagnosis of diseases affecting immune system function, such as
cancer (except basal cell carcinoma of the skin), congenital or acquired
immunodeficiency, uncontrolled autoimmune diseases, etc. (such as systemic lupus
erythematosus, autoimmune thyroid disease, multiple sclerosis);

13. Absence of spleen or functional absence of spleen;

14. Chronic use (≥14 consecutive days) of immunosuppressants or other immunomodulatory
drugs (eg, corticosteroids: prednisone or drugs of the same class) within 6 months
prior to booster vaccination with the investigational vaccine, but topical
medications (eg, ointments, eye drops, inhalers, or nasal sprays) are allowed and
should not exceed the dose recommended in the package insert;

15. Immunoglobulins and/or blood products received within 3 months prior to the
investigational booster vaccination;

16. Suspected or known alcohol dependence or drug abuse that could compromise the safety
evaluation or subject compliance;

17. Other conditions that the investigator considers inappropriate for participation in
this trial.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Chuanmiao Liu
Bangbu, Anhui, China

Fan Zhang, Study Director
AIM Vaccine Co., Ltd.

Ningbo Rongan Biological Pharmaceutical Co., Ltd.
NCT Number