Official Title
A Cohort Study to Evaluate Safety and Immunogenicity of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine (LVRNA012) in Participants Aged 18 Years and Over in China
Brief Summary

This is a cohort study to evaluate safety and immunogenicity of SARS-CoV-2 Variant(Omicron BA.5) mRNA Vaccine (LVRNA012) in participants aged 18 years and over in China

Detailed Description

Not Provided

Unknown status
SARS-CoV-2

Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine low dose

50μg/dose

Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine high dose

100μg/dose

Drug: Placebo

Saline solution

Eligibility Criteria

Inclusion Criteria:

- Age at the time of first dose of vaccine: adults aged 18-59 years (including
boundary values), elderly ≥60 years, both sexes;

- Armpit temperature <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 or SARS 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, or a positive SARS-CoV-2 nucleic acid test or a positive
SARS-CoV-2 IgM or IgG test before the first dose of vaccine;

- History of allergy to any component of the study vaccine or a history of a severe
allergic reaction to the vaccine or drug (including but not limited to anaphylactic
shock, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura,
or local anaphylactic necrosis [Arthus reaction]);

- 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,
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;

- During the screening period, laboratory tests (ALT, AST, troponin, D-dimer) and
electrocardiogram abnormalities were clinically significant;

- Those with evidence of tobacco, alcohol, and drug abuse, and those who did not agree
to abstain from smoking and drinking during the study period;

- Female: those who have a positive blood pregnancy test, are pregnant, breastfeeding,
or have a pregnancy plan within one year; men: whose spouse has a pregnancy plan
within one year;

- Patients have participated in other clinical trials (drugs, biological products or
devices) within 3 months before the first dose of vaccine, or plan to participate in
other clinical trials during the research period;

- Patients received immune enhancement or immunosuppressive therapy within 6 months
before the first dose of vaccine (continuous oral or instillation for more than 14
days);

- Patients donated blood ≥400 ml within 28 days before screening, or received whole
blood, plasma and immunoglobulin therapy within 6 months before screening;

- Currently receiving research drug treatment to prevent COVID-19;

- Patients are taking antipyretic, analgesic and anti-allergic drugs within 3 days
before enrollment;

- The investigator judges that the subjects cannot follow the research procedures,
comply with the agreement, or plan to permanently relocate from the area before the
end of the research, or plan to leave the local area for a long time during the
scheduled visit period;

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

- According to the investigator's judgment, there are other situations that are not
suitable for participating in this clinical trial.

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

Not Provided

Contacts

Huan Zhou
05523086943
byyfygcp@163.com

AIM Vaccine Co., Ltd.
NCT Number
MeSH Terms
Vaccines