Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT05602558
Status:
UNKNOWN
Last Update Posted:
2022-11-02
First Post:
2022-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Phase Ⅱ/Ⅲ Trial of LYB001
Sponsor:
Yantai Patronus Biotech Co., Ltd.
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: