Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT00921206
Status:
COMPLETED
Last Update Posted:
2014-09-23
First Post:
2009-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults
Sponsor:
VaxInnate Corporation
Organization:
Study Overview
Official Title:
Open-label Study to Investigate the Humoral and Cellular Immune Response to Two Doses of VAX102 Influenza Vaccine in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2014-09
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:
The objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.
Detailed Description:
The primary objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination. The magnitude and quality of the M2e-specific B and T cells will be measured. B cell responses will be evaluated on pre-dose Days 0, 28 and post-dose Days 7, 35, 42 and 60. T cell responses will be measured on pre-dose Days 0, 28 and post-dose Days 14, 42 and 60. IgG M2e antibody will be measured on Days 0, 7, 14, 28, 35. 42 and 60. The secondary objective is to assess the safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM or SC at dose levels 1 µg or 2 µg, in a prime-boost dosing regimen, in healthy adults 18-49 years of age, inclusive.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: