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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
Summary
This trial is to test the safety and effectiveness of a new flu vaccine.
Eligible Conditions
- Flu, Pandemic Flu
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 57 compared to day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 57 compared to day 1
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 moreSecondary 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 moreTrial 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
695 Previous Clinical Trials
376,991 Total Patients Enrolled
BlueWillow BiologicsLead Sponsor
1 Previous Clinical Trials
84 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,283 Previous Clinical Trials
5,498,892 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a licensed or experimental H5N1 influenza vaccine at any point in your life.If you had Guillain-Barré syndrome within 6 weeks after getting a flu shot in the past, you cannot participate.You have a history of long-lasting cough, frequent sinus infections, allergies causing stuffy nose, or problems with your nasal passages, including blockages or previous surgeries.You have been using inhalers or nasal sprays for a long time, including ones for allergies and inflammation.You have used drugs or chemicals in an unhealthy or dangerous way within the past year before being screened for the study.You have a weakened immune system, such as having diabetes.You have a history of problems with swallowing or neurological conditions that could increase the risk of inhaling the study medication into your lungs.You have had an allergic or severe reaction to previous flu shots or any of the ingredients in the BW-1014 vaccine.You are allergic to eggs, chicken protein, or any components of the Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).You have had Bell's palsy in the past.You currently use e-cigarettes, smoke cigarettes, or use tobacco products, or have used them within the past year before the screening.
Awards:
This trial has 0 awards, including:Research Study Groups:
This trial has the following groups:- Group 1: Saline (Placebo) - pipette - IN
- Group 2: BW-1014: 25 µg rH5 in 20% NE - pipette - IN
- Group 3: rH5 (100 µg) control - pipette - IN
- Group 4: BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- Group 5: BW-1014: 50 µg rH5 in 20% NE - pipette - IN
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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