NCT05397119: IN-NE-rH5

A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults

Completed Phase 1 Last updated 22 August 2024

What this trial tests

Phase 1 trial testing BW-1014: 25 µg rH5 in 20% NE - pipette - IN in Influenza, Pandemic in 40 participants. Completed in 12 October 2023.

Timeline

7 July 2022

Primary endpoint
12 October 2023

12 October 2023

Quick facts

Lead sponsor	BlueWillow Biologics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	40
Start date	7 July 2022
Primary completion	12 October 2023
Estimated completion	12 October 2023
Sites	1 location across United States

Drugs / interventions tested

• BW-1014: 25 µg rH5 in 20% NE - pipette - IN — full drug profile →
• BW-1014: 50 µg rH5 in 20% NE - pipette - IN — full drug profile →
• BW-1014: 100 µg rH5 in 20% NE - pipette - IN — full drug profile →
• rH5 (100 µg) control - pipette - IN
• Saline (Placebo) - pipette - IN — full drug profile →
• H5N1 IIV - IM — full drug profile →

Conditions studied

• Influenza, Pandemic — all drugs for Influenza, Pandemic →

Sponsor

BlueWillow Biologics — full company profile →

Who can join

Adults 18 to 45, any sex, with Influenza, Pandemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014.

BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.

The study will be conducted in 40 healthy adults volunteers, age 18 - 45, in one center in the United States.

The study will compare 3 different dose levels of rH5 (25µg, 50µg and 100µg rH5 in 20% NE adjuvant using a pipette dropper with rH5 control (100µg without NE adjuvant) and placebo control (saline). The investigational product will be administered in 2 doses intranasally (IN). This will be followed 6 months later with a licensed H5N1 IIV IM vaccine.

In addition to safety outcome, homologous and heterologous immunological outcomes will be tested in nasal wash, serum, and blood cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of Nasal Vaccines and the Associated Challenges.
   Nian X, Zhang J, Zhang J, Huang S, et al · · 2022 · cited 33× · PMID 36297419 · DOI 10.3390/pharmaceutics14101983
2. Vaccine adjuvants for infectious disease in the clinic.
   Goetz M, Thotathil N, Zhao Z, Mitragotri S. · · 2024 · cited 29× · PMID 39036089 · DOI 10.1002/btm2.10663
3. Recent progress in application of nanovaccines for enhancing mucosal immune responses.
   Du G, Qin M, Sun X. · · 2023 · cited 29× · PMID 37425056 · DOI 10.1016/j.apsb.2022.08.010
4. Advancements in Nanoemulsion-Based Drug Delivery Across Different Administration Routes.
   Chatzidaki MD, Mitsou E. · · 2025 · cited 28× · PMID 40143001 · DOI 10.3390/pharmaceutics17030337
5. Nanoplatform Based Intranasal Vaccines: Current Progress and Clinical Challenges.
   Bai Z, Wan D, Lan T, Hong W, et al · · 2024 · cited 14× · PMID 39185745 · DOI 10.1021/acsnano.3c10797
6. Nanotechnology-driven advances in intranasal vaccine delivery systems against infectious diseases.
   Zhang Z, Yang Y, Huang L, Yuan L, et al · · 2025 · cited 4× · PMID 40416956 · DOI 10.3389/fimmu.2025.1573037
7. An intranasal adjuvanted, recombinant influenza A/H5 vaccine primes against diverse H5N1 clades: a phase I trial.
   Deming ME, Toapanta FR, Pasetti M, Golding H, et al · · 2025 · cited 3× · PMID 41198655 · DOI 10.1038/s41467-025-64686-3
8. Next-generation intranasal influenza vaccines: mechanisms, platforms, and translational progress.
   Reis LR, Ross TM. · · 2026 · cited 1× · PMID 42088518 · DOI 10.3389/fimmu.2026.1809302