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Virus Therapy

H5N1 IIV - IM for Flu (IN-NE-rH5 Trial)

Phase 1
Waitlist Available
Led By Justin Ortiz, MD, MS
Research Sponsored by BlueWillow Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 57 compared to day 1
Awards & highlights

IN-NE-rH5 Trial Summary

This trial is to test the safety and effectiveness of a new flu vaccine.

Eligible Conditions
  • Flu, Pandemic Flu

IN-NE-rH5 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 57 compared to day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 compared to day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
+20 more
Secondary outcome measures
Primary Humoral Immune Response Outcome: HI Geometrical Mean Titers levels
Primary Humoral Immune Response Outcome: IgA and IgG endpoint titer levels
Primary Humoral Immune Response Outcome: Rates of seroconversion
+5 more

IN-NE-rH5 Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: BW-1014: 50 µg rH5 in 20% NE - pipette - INExperimental Treatment2 Interventions
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Group II: BW-1014: 25 µg rH5 in 20% NE - pipette - INExperimental Treatment2 Interventions
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Group III: BW-1014: 100 µg rH5 in 20% NE - pipette - INExperimental Treatment2 Interventions
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Group IV: Saline (Placebo) - pipette - INPlacebo Group2 Interventions
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Group V: rH5 (100 µg) control - pipette - INPlacebo Group2 Interventions
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Maryland, BaltimoreOTHER
685 Previous Clinical Trials
373,056 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,267 Previous Clinical Trials
5,480,473 Total Patients Enrolled
BlueWillow BiologicsLead Sponsor
1 Previous Clinical Trials
84 Total Patients Enrolled

Media Library

BW-1014 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05397119 — Phase 1
Flu Clinical Trial 2023: BW-1014 Highlights & Side Effects. Trial Name: NCT05397119 — Phase 1
Flu Research Study Groups: BW-1014: 25 µg rH5 in 20% NE - pipette - IN, Saline (Placebo) - pipette - IN, rH5 (100 µg) control - pipette - IN, BW-1014: 100 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN
BW-1014 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397119 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is enrollment in this clinical trial accessible?

"This clinical trial requires 40 participants aged 18-45 who have influenza pandemic. Furthermore, female applicants must not be pregnant or nursing and will need to use an acceptable birth control method for 3 months prior and following the final vaccination if they are premenopausal. Men and women deemed as being in good health after physical examination can apply, but must also pass a comprehension assessment with a score of 70% or higher (with two attempts permitted). Additionally, those involved should expect their leftover specimens to potentially be used for future research purposes and anticipate receiving the number of doses recommended by the CDC from either EUA authorized or licensed COVID-19 vaccine"

Answered by AI

Has the FDA cleared H5N1 IIV - IM for market usage?

"The safety of H5N1 IIV-IM was cautiously rated as a 1 due to the preliminary nature of this Phase 1 clinical trial, meaning there is scarce evidence regarding its efficacy and safety."

Answered by AI

Can participants still join this clinical experiment?

"The information on clinicaltrials.gov states that, as of 9/21/2022, this medical trial is no longer seeking to recruit patients. However, there are 112 other investigations actively recruiting individuals at the present moment; this study was originally posted on July 7th 2022."

Answered by AI

Are elderly individuals over 85 years of age eligible for participation in this experiment?

"This study's admission criteria requires that participants must lie between the age of 18 and 45. Moreover, there are 40 separate clinical trials dedicated to individuals below 18 while 70 cater towards patients who surpass 65 years old."

Answered by AI

What is the primary aim of this research endeavor?

"As outlined by the trial sponsor, BlueWillow Biologics, the primary outcome over a 36-day period is Mucosal Vaccine Specific IgA Geometric Mean Titer (GMT). Additionally, this investigation will be assessing secondary objectives such as evaluating Hematological and biochemical laboratory abnormality (Class 1 of higher) within 7 days post vaccination with intramuscular H5N1 IIV vaccine; counting Solicited reactions and general AEs within seven days after injection; and monitoring Medical Attended Adverse Events (MAAEs) for up to 28 days following administration."

Answered by AI
~15 spots leftby Apr 2025