This is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine (CHO Cell)(LYB002V14).
The study is a randomized, blinded and dose escalation Phase I clinical trial. It will evaluate the safety and immunogenicity of 2 dose levels of recombinant COVID-19 trivalent (XBB.1+BQ.1.1+Prototype) protein vaccine (CHO Cell)(LYB002V14)in booster vaccination. Approximately 120 participants aged 18 years and older will be enrolled in this study. The subjects in each dose group will randomly receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 0 in the deltoid muscle at 2:1 and will be followed through 12 months post vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
30μg dose of LYB002V14 vaccine IM, on day 0
60μg dose of LYB002V14 vaccine IM, on day 0
placebo IM, on day 0
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Adverse events and adverse reactions
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
Time frame: Day 0 to Day 7
Adverse events and adverse reactions
Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
Time frame: Day 0 to Day 28
Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Statistical description of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) will be listed. Frequencies and percentages of SAEs and AESI, related to vaccination will be followed during the whole observation.
Time frame: Day 0 to Month 12
Laboratory test and vital signs related adverse events.
Indicator of Laboratory test and vital signs related adverse events will be evaluated with three days after booster vaccination.
Time frame: Day 0 to Day 3
Geometric mean titer (GMT), Geometric Mean Fold Rise (GMFR) and seroconversion rate (SCR) of neutralizing antibodies (nAb) against variants of concern circulating during the trial.
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The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, at Day 14、Day 28、Month 3 and Month 6 after booster immunization will be calculated for each group, compared with the baseline.
Time frame: Day 14、Day 28、Month 3 and Month 6
GMT, GMFR and SCR of nAb against Omicron subvariant (XBB)
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against Omicron subvariant (XBB) using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, at Day 14、Day 28、Month 3 and Month 6 after booster immunization will be calculated for each group, compared with the baseline.
Time frame: Day 14、Day 28、Month 3 and Month 6
Geometric Mean Concentration (GMC), GMFR and SCR of SARS-CoV-2 Spike protein binding antibody.
Geometric Mean Concentration(GMC), GMFR and SCR with Clopper-Pearson 95% CIs of S protein-binding antibodies using ELISA assays, at baseline, at Day 14、Day 28、Month 3 and Month 6 after the booster immunization will be calculated for each group, compared with the baseline.
Time frame: Day 14、Day 28、Month 3 and Month 6
Th1 and Th2 cytokine responses
The counts of spot forming cells (SFCs) per 3×10\^5 peripheral blood mononuclear cells (PBMCs) of Cellular immunity RBD-specific IFN-γ and IL-4 cytokine levels at baseline, Day 14 and Month 6 after booster vaccination.
Time frame: Day 14 and Month 6