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 and immunogenicity of the study vaccine in participants aged 18 years and older who have received SARS-CoV-2 Vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
450
100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into the lateral deltoid muscle of the upper arm.
100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper arm.
Chuanmiao Liu
Bengbu, Anhui, China
GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
GMT and SCR of live virus neutralizing antibodys against SARS-CoV-2 ( Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on day 14 after vaccination.
Time frame: 14 day after booster vaccination.
Incidence of solicited and unsolicited adverse events
Incidence of solicited and unsolicited adverse events within 0-28 days after booster vaccination.
Time frame: 0-28 days after booster vaccination.
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs).
Incidence of SAEs and AESIs through 12 months after booster vaccination in all subjects.
Time frame: 12 months after booster vaccination
GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on day 14 after booster vaccination.
Time frame: 14 day after booster vaccination.
GMT, SCR, GMI of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
GMT, SCR, GMI of live virus neutralizing antibodies against SARS-CoV-2 ( Delta strain, Omicron BA.5, XBB strains and current major circulating strains) on days 7 and 28 after booster vaccination.
Time frame: 7, 28 days after booster vaccination.
GMT of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains).
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GMT of live virus neutralizing antibodies against SARS-CoV-2 (Delta strain, Omicron BA.5, XBB strains and current major circulating strains) at 3, 6, 12 months after booster vaccination.
Time frame: 3, 6, 12 months after booster vaccination.
GMC, SCR, GMI of IgG antibodies against S proteins of SARS-CoV-2 ( Delta strain, Omicron BA.5)
GMC, SCR, GMI of IgG antibodies against S proteins of SARS-CoV-2 ( Delta strain, Omicron BA.5) on days 7, 14, and 28 after booster vaccination.
Time frame: 7, 14, 28 days after booster vaccination.
GMC of antibodies against S proteins of SARS-CoV-2 (Delta strain, Omicron BA.5)
GMC of antibodies against S proteins of SARS-CoV-2 (Delta strain, Omicron BA.5) at 3 months, 6 months and 12 months after booster vaccination.
Time frame: 3, 6, 12 months after booster vaccination.