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

Summary

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.

Conditions

• Influenza, Pandemic

Interventions

BIOLOGICAL

BW-1014: 25 µg rH5 in 20% NE - pipette - IN

20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart

BIOLOGICAL

BW-1014: 50 µg rH5 in 20% NE - pipette - IN

20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart

BIOLOGICAL

BW-1014: 100 µg rH5 in 20% NE - pipette - IN

20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart

BIOLOGICAL

rH5 (100 µg) control - pipette - IN

100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart

BIOLOGICAL

Saline (Placebo) - pipette - IN

Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart

BIOLOGICAL

H5N1 IIV - IM

90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization

Sponsors & Collaborators

• University of Maryland, Baltimore

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• BlueWillow Biologics

  lead INDUSTRY

Principal Investigators

• Justin Ortiz, MD, MS · University of Maryland, Baltimore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-07

Primary Completion

2023-10-12

Completion

2023-10-12

FDA Drug

Yes

Countries

• United States

Study Locations