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

Summary

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.

Conditions

• Anthrax

Interventions

BIOLOGICAL

BW-1010: 50 µg - sprayer - IN

20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL). Two doses administered 4 weeks apart.

BIOLOGICAL

BW-1010: 50 µg - pipette - IN

20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.

BIOLOGICAL

BW-1010: 100 µg - sprayer - IN

20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL) Two doses administered 4 weeks apart

BIOLOGICAL

BW-1010: 100 µg - pipette - IN

20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.

BIOLOGICAL

Saline (Placebo) - sprayer - IN

Saline (negative control) administered intranasally by Aptar Bidose Sprayer (400µL). Two doses administered 4 weeks apart.

BIOLOGICAL

Saline (Placebo) - pipette - IN

Saline (negative control) administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.

BIOLOGICAL

BioThrax (positive control) - SC

BioThrax licensed vaccine administered subcutaneously (500µL). Three doses administered 2 weeks apart.

Sponsors & Collaborators

• Porton Biopharma Ltd.

  collaborator UNKNOWN

• BlueWillow Biologics

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-08

Primary Completion

2021-09-02

Completion

2021-09-02

FDA Drug

Yes

Countries

• United States

Study Locations