# Microarray Patch for Broadly Protective Seasonal Influenza Vaccination

> **NIH NIH SB1** · VAXESS TECHNOLOGIES, INC. · 2021 · $1,000,000

## Abstract

Project Summary/Abstract
The World Health Organization estimates that each year influenza causes serious illness in 3 to 5 million
people and up to 650,000 deaths globally. While seasonal vaccines to prevent influenza infection are available,
frequent mutations in the virus require manufacturers to guess which strains will circulate each season and
reformulate the vaccine annually. As a result, the public health benefit of seasonal vaccines is hampered by
poor efficacy (estimated at 36% for the 2017-18 season). This challenge highlights the critical need to improve
influenza vaccines to boost humoral responses (onset, magnitude, and breadth) and generate additional
cellular immunity. Our technology focuses on engineering the sustained release of seasonal influenza vaccine
antigen to mimic natural infection kinetics over 2 weeks, resulting in greater diversity of anti-influenza
antibodies and improved T cell responses. This is accomplished using silk fibroin biomaterial in a microneedle
array format that can be easily administered to the skin. After a brief 5 minute wear time, the silk microneedle
tips are released from the patch and implanted within the dermis. These silk tips are engineered to stabilize
vaccine antigens at body temperature while slowly releasing the antigen payload over 2 weeks. In animal
studies comparing conventional injection to our sustained release approach, we demonstrated a 4-fold
increase in protective T-cells, a 5-fold increase in antibody titers, and significantly higher survival following
lethal challenge. Patch administration was also well tolerated in dermatological models (hairless guinea pigs
and yorkshire swine). Building upon these preclinical proof-of-concept results, the objective of our proposed
work is to prepare for clinical translation and commercialization of this technology through implementation of a
Quality Management System, optimization and finalization of device design, establishment of GMP
manufacturing and other CMC-related activities, and regulatory engagement to ensure compliance with FDA
requirements. Having completed these aims, Vaxess will be positioned to file an IND and begin a Phase 1
clinical study on a path to commercialization of our microarray patch for broadly protective seasonal influenza
vaccination, MIMIX-Flu.

## Key facts

- **NIH application ID:** 10145834
- **Project number:** 1SB1AI164584-01
- **Recipient organization:** VAXESS TECHNOLOGIES, INC.
- **Principal Investigator:** Kathryn Kosuda
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,000,000
- **Award type:** 1
- **Project period:** 2021-04-09 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10145834

## Citation

> US National Institutes of Health, RePORTER application 10145834, Microarray Patch for Broadly Protective Seasonal Influenza Vaccination (1SB1AI164584-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10145834. Licensed CC0.

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