Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442241
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-28
Brief Title:
A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine LYB005 in Healthy Adults
Sponsor:
Guangzhou Patronus Biotech Co Ltd
Organization:
Guangzhou Patronus Biotech Co Ltd
Study Overview
Official Title:
A Phase I Randomized Observer-Blinded Parallel-Controlled Dose Escalation Study to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine CHO Cell LYB005 in Healthy Adults Aged 18 Years and Older
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
A phase 1 randomized observer-blinded parallel-controlled dose escalation study in Australia will evaluate the safety and immunogenicity of the RSV vaccine candidate LYB005 with or without adjuvant in healthy adults aged 18 years and older
Detailed Description:
The study design includes an age- and dose-escalation lowmiddlehigh dose in two adult age groups young adults 18-59 years and older adults 60 years Study will be conducted in two parts part 1 will enrolled young adults and part 2 will enroll older adults A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants Participants will be divided into the sentinel cohort and the remainder of cohort Participants in part 1 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo Participants in part 2 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or positive control AREXVY Detailed characterization of safety including safety laboratory evaluation and immune responses will be observed
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