NCT06417853

Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP)

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Vaxxas Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 (3.3 to 8 mcg), administered by the microarray patch delivery system, compared to IM H7N9 vaccine (7.5 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 (3.3 to 8 mcg), administered by the microarray patch delivery system, compared to IM H7N9 vaccine (7.5 mcg HA) with and without MF59® and uncoated, vaccine-free microarray patch delivery system, administered 21 days apart.

Conditions

• H7N9 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection	7.5 mcg Influenza A (H7N9) Injection
COMBINATION_PRODUCT	Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA)	12 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)
COMBINATION_PRODUCT	Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA)	25 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)
BIOLOGICAL	Adjuvanted Influenza A (H7N9) Monovalent Vaccine Injection	7.5 mcg Influenza A (H7N9) with MF59® Injection
COMBINATION_PRODUCT	Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, low dose adjuvant)	12 mcg Influenza A (H7N9) with 4 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
COMBINATION_PRODUCT	Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, high dose adjuvant)	12 mcg Influenza A (H7N9) with 8 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
COMBINATION_PRODUCT	Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, low dose adjuvant)	20 mcg Influenza A (H7N9) with 3.3 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
COMBINATION_PRODUCT	Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, high dose adjuvant)	20 mcg Influenza A (H7N9) with 6.7 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
DEVICE	Microarray Patch Delivery System	Vaccine free Microarray Patch Delivery System (VXS-1219U)

Timeline

• Start date: 2024-07-31
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2024-05-16
• Last updated: 2026-03-27

Locations

4 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study