Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875676
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2021-04-19
Brief Title:
Immunogenicity Safety Study of Adenovirus Type 5 AD5 Based Oral Norovirus Vaccines
Sponsor:
Vaxart
Organization:
Vaxart
Study Overview
Official Title:
A Phase 1b Open-label Boost-optimization Study of an Adenoviral- Vector Based Oral Norovirus Vaccine VXA-G11-NN Expressing GI1 VP1 Administered Orally to Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2024-05
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:
VXA-NVV-105
Brief Summary:
To evaluate the immunogenicity of VXA-G11-NN with repeat-dose administration at Day 1 and varying boost schedules Week 4 8 or 12 post initial dose in healthy adults aged 18-55 inclusive and to assess the safety and tolerability of VXA- G11-NN with repeat-dose administration at varying boost schedules Week 4 8 or 12 in healthy adults aged 18-55 inclusive
Detailed Description:
None
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