NCT05397119

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

A Ph1 Randomized Double-Blind Controlled Dose-Range Safety Tolerability & Immunogenicity Study of 2 Doses of Intranasal rH5 Flu Vaccine With & Without Nanoemulsion Adjuvant Followed by 1 Boost of Intramuscular H5N1 Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: BlueWillow Biologics · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a single center, phase 1, first-in-human, single-center, randomized, placebo-controlled, double-blind study to assess the safety, tolerability, and immunogenicity of a primary series of intranasal recombinant H5 influenza vaccine with and without nanoemulsion adjuvant followed by boosting dose of licensed, intramuscular influenza A (H5N1) vaccine. Participants will be randomized in one of the following 5 arms: A. BW-1014: 25 µg / 20% NE; 8 participants. B. BW-1014: 50 µg / 20% NE; 8 participants. C. BW-1014: 100 µg / 20% NE; 8 participants. D. rH5 control: 100µg; 8 participants. E. Saline (Placebo); 8 participants. Because this is a dose escalation trial, our study has four stages with one cohort receiving vaccines at each stage. Up to 40 participants will be randomized to one of the five study groups at an allocation ratio depending on the escalation stage. If all participants proceed to vaccination, the final vaccine allocation ratio will be 1:1:1:1:1. Subjects will receive a primary series of two intranasal vaccinations of study treatment administered on Days 1 and 29. Subject dosing will proceed in a stepwise process. Each dose of adjuvanted study vaccine will be assessed in sentinel participants before the remainder of the study group is vaccinated and before proceeding to vaccination of sentinel participants with the next higher dose of adjuvanted study vaccine. Following receipt of the first vaccine dose, sentinel participants will be followed for 7 days for halting criteria and SMC data review prior to proceeding with vaccination of the remainder of the study group. All participants will subsequently receive a third dose of intramuscular, heterologous influenza A (H5N1) vaccine on Day 197. Participants will be followed for safety and immunology endpoints for one year following their second study treatment vaccination. Participants will be assessed for production of specific mucosal and humoral antibodies in addition to cellular immune response in mononuclear cells collected from peripheral blood and from nasal wash fluid throughout the study. These assessments will be to both homologous H5N1 clade 2.1 and heterologous H5N1 clade 1.

Conditions

• Influenza, Pandemic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-10-12
• Completion: 2023-10-12
• First posted: 2022-05-31
• Last updated: 2024-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study