Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03277456
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-09-01
Brief Title:
A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NPM1
Sponsor:
Barinthus Biotherapeutics
Organization:
Barinthus Biotherapeutics
Study Overview
Official Title:
A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NPM1 Manufactured on the AGE1CRpIX Novel Avian Cell Line in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2017-11
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 first in human phase I open label study of the MVA viral vector produced in the novel immortalised duck retinal cell line AGE1CRpIX expressing the influenza antigens NP and M1 as a fusion protein in healthy adult volunteers MVA-NPM1 will be given alone intramuscularly as a single dose
There will be 1 study group and a total of 6 volunteers will be enrolled Staggered enrollment will apply for the first three volunteers within the group
There will be 1 study group and a total of 6 volunteers will be enrolled Staggered enrollment will apply for the first three volunteers within the group
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?:
None