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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
350
SARS-CoV-2 Novel coronavirus S protein antibody (IgG) level
Time frame: At 28 days after full immunization
The levels of neutralizing antibodies of SARS-CoV-2 anti-Novel coronavirus 2019 (Omicron BA.2, BA.4, BA.5 and Delta strains) true virus
Time frame: At 28 days after full immunization
The levels of neutralizing antibodies of SARS-CoV-2 anti-Novel coronavirus 2019 (Omicron BA.2, BA.4, BA.5 and Delta strains) pseudovirus
Time frame: At 28 days after full immunization
Incidence of adverse events
Time frame: Within 14 days and 28 days after each dose of immunization
Incidence of adverse events associated with the study vaccine
Time frame: Within 14 days and 28 days after each dose of immunization
Incidence of SAE
Time frame: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization
Incidence of AESI
Time frame: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization
Incidence of SAE associated with the study vaccine
Time frame: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization
Incidence of AESI associated with the study vaccine
Time frame: Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization
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Incidence of grade ≥3 adverse events
Adverse events were graded from pain, tenderness, itching, induration, swelling and other aspects, and the higher the grade, the more serious the adverse events were
Time frame: Within 28 days after each dose/full dose
Incidence of grade ≥3 adverse events associated with the study vaccine
Adverse events were graded from pain, tenderness, itching, induration, swelling and other aspects, and the higher the grade, the more serious the adverse events were
Time frame: Within 28 days after each dose/full dose
Statistics of withdrawal from the study due to adverse events
Time frame: Within 28 days after each dose/full dose
The level of SARS-CoV-2 S protein antibody (IgG)
Time frame: At 14 days, 3 months, 6 months, and 12 months after full immunization
The positive conversion rate of SARS-CoV-2 S protein antibody
Time frame: At 14 days, 28 days, 3 months, 6 months, and 12 months after full immunization
True virus neutralizing antibody levels of SARS-CoV-2 (Omicron strain BA.2, BA.4, BA.5, Delta strain)
Time frame: At 14 days, 3 months, 6 months, and 12 months after full immunization
Pseudovirus neutralizing antibody levels of SARS-CoV-2 (Omicron strain BA.2, BA.4, BA.5, Delta strain)
Time frame: At 14 days, 3 months, 6 months, and 12 months after full immunization
Positive conversion rates of neutralizing antibodies against true virus of SARS-CoV-2 (Omicron strain BA.2, BA.4, BA.5, Delta strain)
Time frame: At 14 days, 28 days, 3 months, 6 months, and 12 months after full immunization
Positive conversion rates of neutralizing antibodies against pseudovirus of SARS-CoV-2 (Omicron strain BA.2, BA.4, BA.5, Delta strain)
Time frame: At 14 days, 28 days, 3 months, 6 months, and 12 months after full immunization
Cellular immune response levels (IFN-γ) against Novel coronavirus (2019-nCoV)(ELISPOT)
Time frame: At 7 days , 14 days , and 28 days after complete immunization
Cellular immune response levels ( IL-2) against Novel coronavirus (2019-nCoV)(ELISPOT)
Time frame: At 7 days , 14 days , and 28 days after complete immunization
Cellular immune response levels (IL-4) against Novel coronavirus (2019-nCoV)(ELISPOT)
Time frame: At 7 days , 14 days , and 28 days after complete immunization
Cellular immune response levels (IL-13) against Novel coronavirus (2019-nCoV)(ELISPOT)
Time frame: At 7 days , 14 days , and 28 days after complete immunization