This study plans to enrol 1000 participants 18 years and above, with ≥10% participants ≥60 years old. According to SARS-CoV-2 vaccine vaccination history, they will be evenly divided into 2 groups, Group A and Group B. Group A: will enrol 500 participants who have received 2 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. Group B: will enrol 500 participants who have received 3 doses of inactivated SARS-CoV-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago. They will be given one dose of the study vaccine (SYS6006) after enrolment. The study is devided into two stages, the first stage will enrol 200 participants with 100 in Group A and 100 in Group B. They will undergo laboratory examination, immunogenicity observation and safety observation. The first 30 participants in each group will take extra cellular immune testing; the second stage will enrol the remaining 800 participants for safety observation.
All participants: all the 1000 participants enrolled will undergo safety observation. Immunogenicity Subgroup: the first 100 participants enrolled in group A will be assigned to Group A1; the first 100 participants enrolled in group B will be assigned to Group B1. Blood samples will be taken from Group A1 and Group B1 participants (200 in total) for humoral immunity testing and laboratory examination. Laboratory examination include blood routine examination, urine routine test, blood biochemistry, coagulation, thyroid function, cardiac enzymes and troponin. Humoral immunity testing include serum SARS-CoV-2 neutralizing antibody detection as measured by live virus and pseudovirus assay, S1 protein specific IgG binding antibody detection as measured by ELISA. Cellular immunity Subgroup: the first 30 participants enrolled in Group A1 and Group B1 will take extra blood samples for specific cellular immune response (60 in total) as measured by ELISpot.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
all the 1000 participants enrolled will be given one dose of the study SARS-CoV-2 mRNA Vaccine (SYS6006)
the first 30 participants enrolled in each group will take extra blood samples for specific cellular immune response as measured by ELISpot.
the first 100 participants enrolled in each group will take extra blood samples for humoral immunity testing and laboratory examination.
all the 500 participants enrolled will undergo safety observation
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGPrimary Safety Endpoint
* Solicited (local and systemic) adverse events (within 14 days after vaccination) and unsolicited adverse events (within 30 days after vaccination); * Serious Adverse Events (SAE) (within 6 months after vaccination); * Adverse events of special interest (AESI) (within 6 months after vaccination); * Abnormal laboratory examination (4 days after vaccination).
Time frame: 6 months
Primary Immunogenicity Endpoint
Geometric Mean Titer (GMT), Geometric Mean Increase (GMI), Seroconversion (SCR) of SARS-CoV-2 live virus neutralizing antibody (14 days, 30 days post vaccination)
Time frame: 6 months
GMT、GMI、SCR of SARS-CoV-2 pseudovirus neutralizing antibody
1.To evaluate the immunogenicity of one dose of SYS6006 mRNA vaccine as heterologous booster in participants aged 18 years and older who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccine as measured by pseudovirus neutralizing antibody.
Time frame: 14 days, 30 days post vaccination
GMT、GMI、SCR of SARS-CoV-2 S1 protein specific binding IgG antibody
2.To evaluate the immunogenicity of one dose of SYS6006 mRNA vaccine as heterologous booster in participants aged 18 years and older who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccine as measured by S1 protein specific IgG binding antibody.
Time frame: 14 days, 30 days post vaccination
GMT、GMI、SCR of SARS-CoV-2 live virus, pseudovirus neutralizing antibody and S1 protein specific IgG antibody
3.To evaluate the immuno-persistency of one dose of SYS6006 mRNA vaccine as heterologous booster in participants aged 18 years and older who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccine as measured by SARS-CoV-2 live virus neutralizing antibody, pseudovirus antibody and S1 protein specific IgG binding antibody.
Time frame: 3 months, 6 months post vaccination
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