Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417853
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Brief Title:
Influenza A H7N9 Vaccine Delivered Intradermally by High-density Microarray Patch HD-MAP
Sponsor:
Vaxxas Pty Ltd
Organization:
Vaxxas Pty Ltd
Study Overview
Official Title:
Phase I Clinical Study to Evaluate the Safety and Tolerability of a Monovalent Influenza A H7N9 Vaccine Delivered Intradermally by High-density Microarray Patch HD-MAP in Healthy Adults Aged 18 to 50 Years
Status:
RECRUITING
Status Verified Date:
2024-08
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:
HD-MAP
Brief Summary:
Study SP-1219-007 is a multi-centre randomised study designed to access the safety and tolerability of two doses of monovalent Influenza A H7N9 vaccine delivered intradermally by a microarray patch delivery system in healthy adults aged 18 to 50 years
Detailed Description:
258 participants will be randomized to receive two doses Day 1 and 22 of either VXS-1219 VXS-1219 with QS21 adjuvant VXS-1219A an intramuscular comparator H7N9 vaccine or H7N9 MF59 vaccine or an uncoated vaccine-free HD-MAP Delivery system VXS-1219U VXS-1219A is identical to VXS-1219 with the only difference being this investigational product will be formulated with QS21 VXS-1219U the vaccine-free microarray patch delivery system comparator includes a terminally sterilized polymer patch and does not include any vaccine coating formulation on the micro-projections but is otherwise identical to VXS-1219 and VXS-1219A
The primary objective of the study is to evaluate the safety and tolerability of two doses of H7N9 Influenza A vaccine 12 to 25 mcg HA with and without QS21 adjuvant 33 to 8 mcg administered by the microarray patch delivery system compared to IM H7N9 vaccine 75 mcg HA with and without MF59 and uncoated vaccine-free microarray patch delivery system administered 21 days apart
The secondary objectives of the study are to evaluate the immune response to two doses H7N9 Influenza A vaccine 12 to 25 mcg HA with and without QS21 adjuvant 33 to 8 mcg administered by the microarray patch delivery system compared to IM H7N9 vaccine 75 mcg HA with and without MF59 and uncoated vaccine-free microarray patch delivery system administered 21 days apart
The primary objective of the study is to evaluate the safety and tolerability of two doses of H7N9 Influenza A vaccine 12 to 25 mcg HA with and without QS21 adjuvant 33 to 8 mcg administered by the microarray patch delivery system compared to IM H7N9 vaccine 75 mcg HA with and without MF59 and uncoated vaccine-free microarray patch delivery system administered 21 days apart
The secondary objectives of the study are to evaluate the immune response to two doses H7N9 Influenza A vaccine 12 to 25 mcg HA with and without QS21 adjuvant 33 to 8 mcg administered by the microarray patch delivery system compared to IM H7N9 vaccine 75 mcg HA with and without MF59 and uncoated vaccine-free microarray patch delivery system administered 21 days apart
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?:
False
Is an FDA AA801 Violation?:
None