NCT04148118: IN NE-rPA

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

Completed Phase 1 Last updated 18 May 2022

What this trial tests

Phase 1 trial testing BW-1010: 50 µg - sprayer - IN in Anthrax in 84 participants. Completed in 2 September 2021.

Timeline

8 January 2020

Primary endpoint
2 September 2021

2 September 2021

Quick facts

Lead sponsor	BlueWillow Biologics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	84
Start date	8 January 2020
Primary completion	2 September 2021
Estimated completion	2 September 2021
Sites	1 location across United States

Drugs / interventions tested

• BW-1010: 50 µg - sprayer - IN — full drug profile →
• BW-1010: 50 µg - pipette - IN — full drug profile →
• BW-1010: 100 µg - sprayer - IN — full drug profile →
• BW-1010: 100 µg - pipette - IN
• Saline (Placebo) - sprayer - IN — full drug profile →
• Saline (Placebo) - pipette - IN — full drug profile →
• BioThrax (positive control) - SC

Conditions studied

• Anthrax — all drugs for Anthrax →

Sponsor

BlueWillow Biologics — full company profile →

Who can join

Adults 18 to 49, any sex, with Anthrax. 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-1010.

BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to anthrax.

The vaccine will be administered intranasally (IN) to healthy adults, age 18 - 49.

The study will be conducted in 84 volunteers in one center in the United States.

The study will compare 2 different dose levels of rPA (50µg and 100µg rPA), and 2 different administration methods (a sprayer and dropper) with a negative control (saline) and a positive control (the injectable BioThrax licensed vaccine).

The vaccines and negative controls will be administered in 2 IN doses (4 weeks apart). The positive control will be 3 subcutaneous doses, 2 weeks apart. All volunteers will be observed for 1 year after the last dose.

Immunological outcome studied will be from the serum, blood cells and nasal washes.

Publications & conference data

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

1. Mucosal vaccines - fortifying the frontiers.
   Lavelle EC, Ward RW. · · 2022 · cited 513× · PMID 34312520 · DOI 10.1038/s41577-021-00583-2
2. Advances in intranasal vaccine delivery: A promising non-invasive route of immunization.
   Kehagia E, Papakyriakopoulou P, Valsami G. · · 2023 · cited 69× · PMID 37179163 · DOI 10.1016/j.vaccine.2023.05.011
3. Current view on novel vaccine technologies to combat human infectious diseases.
   Matić Z, Šantak M. · · 2022 · cited 47× · PMID 34889981 · DOI 10.1007/s00253-021-11713-0
4. 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
5. 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
6. Advancements in Nanoemulsion-Based Drug Delivery Across Different Administration Routes.
   Chatzidaki MD, Mitsou E. · · 2025 · cited 28× · PMID 40143001 · DOI 10.3390/pharmaceutics17030337
7. Technological Approaches for Improving Vaccination Compliance and Coverage.
   Lemoine C, Thakur A, Krajišnik D, Guyon R, et al · · 2020 · cited 21× · PMID 32560088 · DOI 10.3390/vaccines8020304
8. Enhanced mucosal SARS-CoV-2 immunity after heterologous intramuscular mRNA prime/intranasal protein boost vaccination with a combination adjuvant.
   Laghlali G, Wiest MJ, Karadag D, Warang P, et al · · 2024 · cited 19× · PMID 39489918 · DOI 10.1016/j.ymthe.2024.10.016