This is a randomized, blinded, positive-controlled study to evaluate the safety and immnunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above. 100 subjects will be recruited in this study, including 50 aged 18-59 years old and 50 aged 60 years old and above.
All subjects will be received 3 doses of LYB001, according to the immunization schedule of 0, 28, 56 days. The adverse events within 28 days after vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,day 14 after dose 2, and on day 14, 28 and month 3, 6, 9, 12 after full vaccination. Serum antibody levels, cellular immune responses will be analyzed to evaluate the immunogenicity and immune persistence of the vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
This vaccine is prepared through gene recombination and 3 doses of low-dose(30µg/0.5ml) LYB001 at the schedule of 0, 28, 56 days.
This vaccine is Positive-controlled vaccine and 3 doses (0.5ml) at the schedule of 0, 28, 56 days.
This vaccine is prepared through gene recombination and 3 doses of high-dose(60µg/0.5ml) LYB001 at the schedule of 0, 28, 56 days.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
The incidence of adverse reactions (ARs)
The incidence of adverse reactions (ARs) within 7 days after each vaccination
Time frame: Day 0-7 days after each vaccination
The occurrence of adverse events
The occurrence of adverse events within 28 days after vaccination
Time frame: Day 0-28 days after each vaccination
The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs)
The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1, dose2 and dose 3.
Time frame: Day 0 to 12 months after dose1, dose2 and dose 3.
Laboratory safety measures: coagulation, blood biochemistry, complete blood count and urinalysis
The change of laboratory safety measures on day 3 after each vaccination in comparison with that before vaccination.
Time frame: Day 3 after each vaccination.
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
GMT of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28 , month 3, month 6, month 12 after full vaccination.
Time frame: Day 14 after the second dose, day 14 , day 28 ,month 3, month 6, month 12 after full vaccination.
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
GMFR of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.
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Time frame: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.
Time frame: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.
GMT of binding antibody against S protein of SARS-CoV-2 wild strain.
GMT of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.
Time frame: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.
GMFR of binding antibody against S protein of SARS-CoV-2 wild strain.
GMFR of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.
Time frame: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.
Seroconversion rate of of binding antibody against S protein of SARS-CoV-2 wild strain.
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.
Time frame: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.
The cytokine levels (Elispot): Th1 type: IL-2, IFN-γ; Th2 type: IL-4.
The cytokine levels (Elispot) at day 14 after the second dose, day 14 after full vaccination.
Time frame: Day 14 after the second dose, day 14 after full vaccination.