Ignite Creation Date:
2024-05-06 @ 12:56 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03883113
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2019-02-21
Brief Title:
Efficacy of MVA-NPM1 in the Influenza H3N2 Human Challenge Model
Sponsor:
Barinthus Biotherapeutics
Organization:
Barinthus Biotherapeutics
Study Overview
Official Title:
Efficacy of MVA-NPM1 in the Influenza H3N2 Human Challenge Model
Status:
COMPLETED
Status Verified Date:
2021-03
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 2 single center randomized double blind study evaluating the safety efficacy and immunogenicity of MVA NPM1 in the H3N2 human influenza challenge model on healthy adult volunteers
Detailed Description:
The study consists of an outpatient vaccination phase 155 participants and at least 2 months later an inpatient challenge phase 134 participants Participants are randomized 9362 to receive either MVA-NPM1 or Placebo Up to 20 participants will be challenged over several 3-week blocks and the remainder at the final 3-week block for a total of 80 MVA-NPM1 and 54 Placebo recipients challenged
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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