CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
BW-1014: 25 µg rH5 in 20% NE - pipette - IN +5 morebiological
Likely dose
BW-1014: 25 µg rH5 in 20% NE - pipette - INfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05397119
NCT05397119Phase 1Completed
CompareCT.gov

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

BlueWillow Biologics·interventional·Posted May 31, 2022·Updated Aug 22, 2024

In Brief

A Phase 1 clinical trial evaluating BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, and 4 other interventions for Influenza, Pandemic. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Pandemic
CountriesUnited States
CollaboratorsUniversity of Maryland, Baltimore, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedMay 31, 2022
Enrollment StartJul 7, 2022
Primary CompletionOct 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.1 years ago

Interventions

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

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

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

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

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

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

rH5 (100 µg) control - pipette - INbiological

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

Saline (Placebo) - pipette - INbiological

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

H5N1 IIV - IMbiological

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