Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335849
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-13
Brief Title:
A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine CHO Cell LYB004 in Adults Aged 50 to 70 Years
Sponsor:
Guangzhou Patronus Biotech Co Ltd
Organization:
Guangzhou Patronus Biotech Co Ltd
Study Overview
Official Title:
A Phase I Randomized Observer-blinded Positive-Controlled Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine CHO Cell LYB004 in Adults Aged 50 to 70 Years
Status:
RECRUITING
Status Verified Date:
2024-09
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 phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine CHO Cell LYB004 in Adults Aged 50 to 70 Years
Detailed Description:
A randomized observer-blinded positive-controlled dose escalation trial will be conducted to observe the safety and immunogenicity of LYB004 in adults 50 to 70 years of age A total of 48 healthy subjects will be enrolled and stratified by age 50-59 years and 60-70 years in a 11 ratio and randomized 21 to receive LYB004 or SHINGRIX Two dose levels of LYB004 will be provided low dose 25 μg and high dose 50 μg The two-dose immunization schedule will be adopted that is LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60 respectively
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