To evaluate the safety, humoral immunogenicity, cellular immunogenicity and immune persistence following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;
Main Objective 1. To evaluate the safety following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine; 2. To evaluate the humoral immunogenicity following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine; Secondary Objectives To evaluate the immune persistence following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine; For exploratory purposes To evaluate the cellular immunogenicity following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
210
Participants receiving one or two boost doses of LYB002V14 after a three-dose primary series of inactivated COVID-19 vaccine.
Participants receiving one or two boost doses of LYB002V14A after a three-dose primary series of inactivated COVID-19 vaccine.
Participants at 18-59 years old receiving two boost doses of LYB002CA after a three-dose primary series of inactivated COVID-19 vaccine.
Affiliated Hospital of North Sichuan MedicalCollege
Chengdu, Sichuan, China
The frequencies and percentages of adverse events within 30 minutes of each booster dose
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups. Solicited and unsolicited AEs within 30 mins after vaccination will be collected
Time frame: within 30 minutes after booster vaccination
The frequencies and percentages of adverse events within 7 days of each booster dose
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups. Solicited local/systemic AEs within 7 days of booster dose will be collected
Time frame: 7 days after booster vaccination
The frequencies and percentages of adverse events within 28 days of each booster dose
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups. Unsolicited AEs within 28 days of booster dose will be collected
Time frame: 28 days after booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-bindingantibodies at 14 days after each booster immunization
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The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 14 days after each booster immunization will be calculated for each group, compared with the baseline.
Time frame: 14 days after each booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-bindingantibodies at 28 days after each booster immunization
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 28 days after each booster immunization will be calculated for each group, compared with the baseline.
Time frame: 28 days after each booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and Sprotein-binding antibodies at 14 days after each booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, Sprotein-binding antibodies using ELISA assays, at baseline, at 14 days after the booster immunization will be calculated for each group, compared with the baseline.
Time frame: 14 days after each booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and Sprotein-binding antibodies at 28 days after each booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, Sprotein-binding antibodies using ELISA assays, at baseline, at 28 days after the booster immunization will be calculated for each group, compared with the baseline.
Time frame: 28 days after each booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at baseline, at 14 days after the booster immunization will be calculated for each group, compared with the baseline.
Time frame: 14 days after each booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at baseline, at 28 days after the booster immunization will be calculated for each group, compared with the baseline.
Time frame: 28 days after each booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 3 months after the last booster immunization will be calculated for all participants.
Time frame: 3 months after the last booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and GMC of Sprotein-binding antibodies
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, the GMC of Sprotein-binding antibodies using ELISA assays, at 3 months after the last booster immunization will be calculated for all participants.
Time frame: 3 months after the last booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 3 months after the last booster immunization will be calculated for all participants.
Time frame: 3 months after the last booster vaccination
The frequencies and percentages of adverse events
The incidence of serious adverse events (SAE) and adverse events of special interest (AESI) in all participants within 6 months after the last booster dose;
Time frame: 6 months after the last booster vaccination
The changes of the frequencies and percentages of adverse events from the baseline at the 3rd day after each boost vaccination
the changes of laboratory tests on the third day after each dose of booster vaccination compared with those before vaccination
Time frame: 3 days after each booster vaccination