The Phase Ⅱ/Ⅲ Trial of LYB001
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|ClinicalTrials.gov Identifier: NCT05602558|
Recruitment Status : Not yet recruiting
First Posted : November 2, 2022
Last Update Posted : November 2, 2022
The study will be conducted in two phases using a randomized, double-blind, placebo-controlled design. A phase II trial will be initiated to assess the safety of LYB001 as booster shots, and then proceed to a phase III trial to assess the vaccine efficacy (VE) of LYB001 against COVID-19 after an acceptable safety profile, per the judgement of Data and Safety Monitoring Board (DSMB), within 28 days after booster in the phase Ⅱ trial is assessed. After collection of 155 COVID-19 cases, all participants will get unblinded. Participants assigned to the placebo group can choose to receive LYB001 vaccine at their own discretion.
Phase II stage:
The purpose of phase Ⅱ study is to assess the safety of healthy subjects aged 18 years and older who have completed two-dose or three-dose inactivated COVID-19 vaccine for 6-18 months. About 200 age s-stratified subjects aged over 18 years will be randomly assigned to receive the LYB001 or placebo in a 1:1 ratio in the deltoid muscle of the upper arm.
The Phase III study will be initiated after the DSMB confirm that all subjects in Phase II experience acceptable safety profile within 28 days after booster. All subjects in Phase II trial will be required to complete efficacy follow-ups for 12 months along with safety observation, and will be included in the Phase III efficacy analysis set (Phase II data will eventually be combined with Phase III data for statistical analysis, including efficacy and safety data).
Phase III stage:
A total of 17800 participants aged 18 years and older who have completed two-dose or three-dose inactivated COVID-19 vaccine for 6-18 months. The participants will be randomly assigned to the LYB001 booster or placebo booster group in 1:1 ratio according stratification factors of study center and age (18-59 years vs. ≥60 years) , with participants aged ≥ 60 years accounting for over 20 percent of total population.
After booster vaccination, all subjects will be evaluated for protective efficacy and safety, and 1000 subjects (800 subjects aged 18-59 years, and 200 subjects aged ≥60 years) will be enrolled in the subgroup for immunogenicity evaluation (LYB001: Placebo=1:1).
All subjects will be followed up to 12 months after booster vaccination. The entire clinical study will be completed after the pre-defined COVID-19 cases has been achieved and each participant has completed 12-month follow-ups.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: LYB001 Biological: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blinded, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Older Completed Two-dose or Three-dose Inactivated COVID-19 Vaccine|
|Estimated Study Start Date :||December 2022|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||February 2024|
The antigen consists of receptor-binding domain (RBD) from wild-type SARS-CoV-2 displaying on virus-like particle (VLP) vector, adjuvanted with aluminium hydroxide.
|Placebo Comparator: Placebo||
Aluminium hydroxide adjuvant
- First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up [ Time Frame: 14 days after the booster ]
- First occurrence of confirmed severe, critical, and fatal COVID-19 incidence per person-years of follow-up [ Time Frame: 14 days after the booster ]
- Solicited local/systemic adverse events [ Time Frame: 7 days after the booster ]
- Unsolicited adverse events [ Time Frame: 28 days after the booster ]
- Geometric mean titers of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup [ Time Frame: 14days, 28 days after booster, and 3, 6, 12 months after booster ]
- Geometric mean fold rises of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup [ Time Frame: 14days, 28 days after booster, and 3, 6, 12 months after booster ]
- Seroconversion rates of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup [ Time Frame: 14days, 28 days after booster, and 3, 6, 12 months after booster ]