Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06167915
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-12-11
Brief Title:
Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine CHO CellLYB002V14 in Booster Vaccination
Sponsor:
Guangzhou Patronus Biotech Co Ltd
Organization:
Guangzhou Patronus Biotech Co Ltd
Study Overview
Official Title:
A Randomized Blinded Placebo-Controlled Dose Escalation Phase 1 Trial of Recombinant COVID-19 Trivalent XBB1BQ11Prototype Protein Vaccine CHO CellLYB002V14 in Booster Vaccination in Participants Aged 18 Years Old and Above
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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:
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 XBB1BQ11Prototype Protein Vaccine CHO CellLYB002V14
Detailed Description:
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 XBB1BQ11Prototype protein vaccine CHO CellLYB002V14in 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 21 and will be followed through 12 months post vaccination
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?:
None