# Addressing unanticipated events for Intranasal Influenza H5 Vaccine Trial

> **NIH NIH U01** · UNIVERSITY OF MARYLAND BALTIMORE · 2022 · $167,385

## Abstract

Project Summary/Abstract
The burden of seasonal influenza illness, the continuing threat of a pandemic, and the inadequacy of current
influenza vaccines emphasize the urgent need for improved influenza vaccines. Vaccines that stimulate the
mucosal immune system are a promising approach because the upper respiratory mucosa serves as the
primary site of infection and because influenza-specific mucosal antibodies are associated with influenza
prevention. With this proposal, we will advance the understanding of mucosal immune response to intranasal
influenza vaccination. Our goal is to establish a proof-of-principle that a novel mucosal H5N1 vaccine (BW-
1014) is safe and can induce a mucosal immunologic response. BW-1014 is nanoemulsion-adjuvanted
recombinant H5 influenza vaccine administered intranasally. We will evaluate BW-1014 given at three different
antigen doses with nanoemulsion adjuvant, an antigen only formulation as an active comparator, and placebo
as an inactive comparator. Two vaccinations of study vaccine will be given to volunteers aged 18 through 39
years on days 1 and 29. Subsequently, all volunteers will receive licensed, parenteral Influenza Virus Vaccine,
H5N1 (heterologous to the primary series) as a booster dose on day 197. Participants will be followed for 13
months for safety outcomes, and they will provide blood and nasal wash specimens at several time points for
humoral, cell-mediated, and mucosal immune assays. The trial is designed to generate valuable information
about the immune responses to mucosal vaccination while minimizing the risk to volunteers of a new vaccine
given to humans for the first time. These are the project research aims:
  Aim 1. Assess the safety and tolerability of intranasal BW-1014
  Aim 2. Assess the mucosal immune response of intranasal BW-1014
  Aim 3. Examine the immune response to a primary series of intranasal BW-1014 followed by a boosting
 dose of heterologous parenteral H5N1 vaccine
These research aims will be assessed within the context of a clinical trial to be conducted according to local
legal and regulatory requirements, applicable US federal regulations, ICH guidelines, and Good Clinical
Practice (GCP) standards. We have a plan for ensuring clinical monitoring, ongoing quality management with
quality assurance and quality control activities, external independent safety oversight, and data management.

## Key facts

- **NIH application ID:** 10620369
- **Project number:** 4U01AI148081-03
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Justin R. Ortiz
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $167,385
- **Award type:** 4C
- **Project period:** 2022-08-08 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10620369

## Citation

> US National Institutes of Health, RePORTER application 10620369, Addressing unanticipated events for Intranasal Influenza H5 Vaccine Trial (4U01AI148081-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10620369. Licensed CC0.

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