This is a randomized, blinded, positive-controlled study to evaluate the immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above(negative antibody against COVID-19). 720 subjects will be recruited in this study, including 360 in 1 dose of 30 or 60 μg group and 360 in 2 doses of 30 or 60 μg group. The age group consists of 18-59 years old and 60 years old and above.
Subjects will receive 1 dose or 2 doses of LYB001, according to the immunization schedule of 0 day or 0, 28 days. The adverse events within 28 days after each vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,and on day 7, 14, 28 and month 3, 6, 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
The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated at day 0 and 28. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.
Time frame: Day 14 after full vaccination.
The occurrence of adverse events
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination
Time frame: 30 mins,7 days and 28 days after each vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1 and dose2
Time frame: Day 0 to 12 months after dose1and dose2
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 7, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Time frame: Day 7 , 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)
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day14, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Time frame: Day 7, 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs).
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time frame: Day 7, 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 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain.
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Seroconversion rate 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 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination