# An integrated fiber-microneedle device to study and optimize immune responses

> **NIH NIH R56** · UNIVERSITY OF WASHINGTON · 2020 · $745,214

## Abstract

PROJECT SUMMARY
Strengthening mucosal immune responses by oral vaccination has the potential to improve the efficacy of
current vaccine strategies against HIV by eliciting protective immunity at sites of virus entry in mucosal tissues.
The oral mucosa is a promising route for vaccination due to direct access to rich lymphoid tissue, and shared
immunological features with the vaginal and rectal mucosae that would predict lymphocyte homing and
common effector mechanisms at these mucosal surfaces. However, the development of oral vaccines has
been partially hindered by our incomplete understanding of how to elicit vaccine-induced innate immunity in the
oral cavity that will lead to robust and long-term mucosal and systemic adaptive immune responses against
HIV. In particular, defining the immune correlates of protection related to the oral immunization site (buccal,
sublingual, tonsillar ring) and the use of immune-enhancing adjuvants will enhance our understanding of oral
immunity and inform development of oral vaccines. Here, we take advantage of an innovative technology for
localized vaccine delivery combined with an innovative approach using fractional factorial experimental designs
in nonhuman primates to delineate factors that will contribute to HIV-specific immunity from directly immunizing
the oral mucosa. We have developed a solid oral dosage form integrating drug-eluting fibers into microneedles
that has the capacity to increase vaccine retention time, modulate vaccine delivery kinetics, and localize the
vaccine dose to the specific site of oral immunization. We propose to use our integrated fiber and microneedle
device (iFMD) as a tool to investigate the effect that adjuvant-induced in situ expansion of antigen presenting
cells (APCs) has on maximizing oral innate immunity to DNA vaccines. We hypothesize that expanding
immunogenic oral dendritic cells will correlate with robust local and systemic adaptive immune responses. Our
specific aims provide a framework that leverages innovative attributes of our iFMD technology with nonhuman
primate oral mucosal models and cutting-edge next-generation sequencing tools to identify oral immune
correlates of protection. This approach is enabled by a multidisciplinary team with expertise in mucosal vaccine
delivery, microneedle device design and fabrication, and relevant nonhuman primate models and
immunological tools to analyze oral immunization strategies. The success of this research proposal will expand
our knowledge of oral immunity and inform development of strategies to elicit protective immunity against HIV
transmission in the oral cavity and at other mucosal surfaces.

## Key facts

- **NIH application ID:** 10241699
- **Project number:** 1R56DE028539-01A1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Deborah H. Fuller
- **Activity code:** R56 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $745,214
- **Award type:** 1
- **Project period:** 2020-09-08 → 2023-03-07

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10241699

## Citation

> US National Institutes of Health, RePORTER application 10241699, An integrated fiber-microneedle device to study and optimize immune responses (1R56DE028539-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10241699. Licensed CC0.

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