BW-1014: 25 µg rH5 in 20% NE - pipette - IN for Influenza, Pandemic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD
Influenza, Pandemic+1 More
H5N1 IIV - IM - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Influenza, Pandemic

Treatment Effectiveness

Study Objectives

23 Primary · 8 Secondary · Reporting Duration: Day 57 compared to Day 1

Day 197
Safety endpoint: Number of participants reporting local or systemic reactions to intramuscular H5N1 IIV vaccine
Day 204
Safety endpoint: Number of participants reporting any hematological and biochemical laboratory abnormality (Class 1 of higher)
Safety endpoint: Number of participants reporting solicited reactions and general AEs
Day 225
Safety endpoint: Number of participants reporting medically attended AEs (MAAEs)
Safety endpoint: Number of participants reporting unsolicited AEs
Day 57
Primary Humoral Immune Response Outcome: Rates of seroconversion
Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific CD107a
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Granzyme B
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IFN-gamma
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-10
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-2
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-21
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-4
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell memory subset (central memory cell)
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell memory subset (effector memory CD45RA+ cell)
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell memory subset (effector memory cell)
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific TNF-α
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific activation marker (CD154), cytokines/chemokines
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific activation marker (CD69), cytokines/chemokines
Primary Mucosal Immunogenicity Outcome: Mucosal vaccine-specific IgA Geometric Mean Titer (GMT)
Primary Mucosal Immunogenicity Outcome: Mucosal vaccine-specific IgG Geometric Mean Titer (GMT)
Up to Day 29
Safety Outcome: Number of participants reporting local or systemic reactions
Up to Day 36
Safety Outcome: Number of participants reporting solicited reactions and general AEs
Up to Day 393
Safety Outcome: Number of participants reporting new onset chronic medical conditions (NOCMCs)
Safety Outcome: Number of participants reporting potential immune-mediated medical conditions (PIMMCs)
Safety Outcome: Number of participants reporting serious adverse events (SAEs)
Up to Day 43
Safety Outcome: Number of participants reporting any hematological and biochemical laboratory abnormality (Class 1 of higher)
Up to Day 57
Primary Humoral Immune Response Outcome: HI Geometrical Mean Titers levels
Primary Humoral Immune Response Outcome: IgA and IgG endpoint titer levels
Safety Objective: Number of participants reporting unsolicited AEs
Safety Outcome: Number of participants reporting medically attended AEs (MAAEs)

Trial Safety

Trial Design

5 Treatment Groups

BW-1014: 25 µg rH5 in 20% NE - pipette - IN
1 of 5
BW-1014: 100 µg rH5 in 20% NE - pipette - IN
1 of 5
BW-1014: 50 µg rH5 in 20% NE - pipette - IN
1 of 5
Saline (Placebo) - pipette - IN
1 of 5
rH5 (100 µg) control - pipette - IN
1 of 5
Experimental Treatment
Non-Treatment Group

40 Total Participants · 5 Treatment Groups

Primary Treatment: BW-1014: 25 µg rH5 in 20% NE - pipette - IN · Has Placebo Group · Phase 1

BW-1014: 25 µg rH5 in 20% NE - pipette - INExperimental Group · 2 Interventions: H5N1 IIV - IM, BW-1014: 25 µg rH5 in 20% NE - pipette - IN · Intervention Types: Biological, Biological
BW-1014: 100 µg rH5 in 20% NE - pipette - INExperimental Group · 2 Interventions: H5N1 IIV - IM, BW-1014: 100 µg rH5 in 20% NE - pipette - IN · Intervention Types: Biological, Biological
BW-1014: 50 µg rH5 in 20% NE - pipette - INExperimental Group · 2 Interventions: H5N1 IIV - IM, BW-1014: 50 µg rH5 in 20% NE - pipette - IN · Intervention Types: Biological, Biological
Saline (Placebo) - pipette - INShamComparator Group · 2 Interventions: Saline (Placebo) - pipette - IN, H5N1 IIV - IM · Intervention Types: Biological, Biological
rH5 (100 µg) control - pipette - INPlaceboComparator Group · 2 Interventions: H5N1 IIV - IM, rH5 (100 µg) control - pipette - IN · Intervention Types: Biological, Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 57 compared to day 1
Closest Location: Center for Vaccine Development and Global Health, University of Maryland School of Medicine · Baltimore, MD
Photo of Baltimore  1Photo of Baltimore  2Photo of Baltimore  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Influenza, Pandemic
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a healthy man or woman aged 18 through 45 years of age, inclusive.
Subjects must be able to comprehend the study requirements as evidenced by a score of ≥ 70% on the comprehension assessment (two attempts permitted), be available for the required study period, and have the ability to attend scheduled visits.
Subjects must be able to provide written informed consent to participate in the study.
You agree to use the left-over specimens and to collect additional specimens for future use research.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.