Influenza, PandemicPhase 1IN-NE-rH5NCT05397119
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
A Phase 1 study testing BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN and BW-1014: 100 µg rH5 in 20% NE - pipette - IN in people with Influenza, Pandemic, run by BlueWillow Biologics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Pandemic
- What is being tested?
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN and BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 12 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or women aged 18 through 45 years of age, inclusive.
- Women must not be pregnant or nursing. If premenopausal, absence of pregnancy must be confirmed by a negative serum pregnancy test conducted at screening and a negative urine pregnancy test conducted at the site within 24 hours preceding receipt of vaccine.
- Women who are not surgically sterile or at least one year post-menopausal must agree to use acceptable birth control. Acceptable birth control methods include oral, implantable, transdermal or injectable contraceptive; barrier methods such as condoms, cervical caps, or diaphragms with spermicide; abstinence from sexual relationships with a male partner, non-male sexual relationships, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, and other reliable forms of contraception approved by the Investigator. Acceptable birth control must be used for a minimum of 30 days prior to vaccination and for 3 months following final study vaccination.
- Subjects must be in good general health, as determined by medical history and physical examination. Acceptable vital signs and clinical laboratory examinations are within the normal range per study toxicity tables (Appendix B). Vital signs and clinical laboratory examinations meeting Grade 1 criteria may also be acceptable in the opinion of the PI or appropriate Sub-Investigator. For this study, an appropriate Sub-Investigator is a designated clinician licensed to make medical diagnoses and listed on the Form FDA 1572. Exclusionary clinical laboratory examinations may be repeated one time to assess clinical improvement in the event temporary halting criteria (described in Section 8.6.2) are met at the time of the first examination.
- 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.
- Subject agrees to future use of left-over specimens and to the collection of additional specimens for potential future use research.
- Receipt of the CDC-recommended number of doses of an EUA authorized or licensed COVID-19 vaccine product ≥ four weeks prior to first study vaccination.
Who cannot join
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months). This includes signs or symptoms consistent with upper or lower respiratory tract infections.
- Participants with symptoms of COVID-19 and/or who are positive for SARS-CoV-2 by molecular testing conducted within 2 days prevaccination.
- Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
- Receipt of licensed or experimental H5N1 influenza vaccine ever.
- Subjects with a history of chronic cough, frequent sinus infections, sinusitis, allergic rhinitis, nasal polyps or obstruction, including deviated septum significant enough to obstruct the nasal openings or a history of nasal surgery.
- Body mass index (BMI) BMI ≤ 18.5 or ≥ 40.
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- Positive serology for human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis B, or hepatitis C (HCV).
- Platelet count less than 100,000/mm prior to randomization during baseline visit.
- History of drug or chemical abuse within the past year prior to screening.
- History of aspiration, dysphagia, swallowing disorders, stroke or other neurologic conditions that may predispose the subject to aspiration of test articles into the respiratory tract.
- History of Bell's palsy.
- History of Guillain-Barré syndrome within 6 weeks of prior influenza virus vaccine.
- Cancer or treatment for cancer, within 3 years. Basal cell carcinoma or squamous cell carcinoma are allowed, unless present on or near the nose.
- Impaired immune responsiveness, including a history of diabetes mellitus.
- Chronic use of inhaled or intranasal sprays including decongestants and corticosteroids.
- A current vaper, smoker or tobacco user or a history of smoking or tobacco use within the past year prior to screening.
- Receipt or history of receiving any medications or treatments that affected the immune system such as immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months.
- Has received or has plans to receive any licensed or authorized vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to first study vaccination through Day 57.
- History of allergic and/or anaphylactic type reaction to injected influenza vaccines or to any of the components of BW-1014 [soybean oil, dehydrated alcohol (anhydrous ethanol), polysorbate (Tween 80), cetylpyridinium chloride (CPC), and tobacco].
- Receipt of any investigational product or nonregistered drug within the 30 days before screening or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing 13-month period.
- Use of nasally administered prescription or over-the-counter medications within 7 days before vaccination.
- Receipt of blood or blood products 8 weeks before screening or planned administration prior to the Week 8 visit.
- Donation of blood or blood products within 8 weeks before screening or at any time up to the Week 4 clinic visit.
- If a subject presents at screening or on a vaccination date with an acute illness, the Investigator will refer to Individual Halting Criteria to assess whether to temporarily delay enrollment or vaccination until the illness is resolved.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Vaccine Development and Global Health, University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
Official title: 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
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.
Read more
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.
Read the 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:
- 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
- Being tested
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, BW-1014: 100 µg rH5 in 20% NE - pipette - IN, rH5 (100 µg) control - pipette - IN, Saline (Placebo) - pipette - IN
- Keywords
- Pandemic influenza, Nanoemulsion adjuvant, Nasal vaccine, rH5
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| BW-1014: 25 µg rH5 in 20% NE - pipette - IN | Experimental | 20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart Receives: Biological: BW-1014: 25 µg rH5 in 20% NE - pipette - IN; Biological: H5N1 IIV - IM |
| BW-1014: 50 µg rH5 in 20% NE - pipette - IN | Experimental | 20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart Receives: Biological: BW-1014: 50 µg rH5 in 20% NE - pipette - IN; Biological: H5N1 IIV - IM |
| BW-1014: 100 µg rH5 in 20% NE - pipette - IN | Experimental | 20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart Receives: Biological: BW-1014: 100 µg rH5 in 20% NE - pipette - IN; Biological: H5N1 IIV - IM |
| rH5 (100 µg) control - pipette - IN | Placebo comparator | 100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart Receives: Biological: rH5 (100 µg) control - pipette - IN; Biological: H5N1 IIV - IM |
| Saline (Placebo) - pipette - IN | Sham comparator | Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart Receives: Biological: Saline (Placebo) - pipette - IN; Biological: H5N1 IIV - IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome: Number of Participants Reporting Local or Systemic Reactions After First Intranasal Vaccination
Local and systemic reactions will be assessed in the clinic within 1 hour of intranasal BW-1014, positive control, and placebo administration, including visual assessment of nasal passages
Measured: Within one hour of first intranasal vaccination
Safety Outcome: Number of Participants Reporting Solicited Reactions and General AEs After First Intranasal Vaccination
Solicited reactions and general AEs will be assessed in follow up visit/phone call within 7 days of first intranasal vaccination with intranasal BW-1014, positive control and placebo
Measured: 7 days
Safety Objective: Number of Participants Reporting Unsolicited AEs
Number and proportion of participants reporting unsolicited adverse events within 28 days after each intranasal vaccination with BW-1014, rH5 control, or placebo, assessed at study Days 29 and 57.
Measured: Day 29 and Day 57 (each summarizing unsolicited adverse events occurring during the preceding 28-day period)
Safety Outcome: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher) Within 7 Days of the First Intranasal Vaccination
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed in follow-up visits within 7 days after the first intranasal vaccination with BW-1014, rH5 control, or placebo using protocol-specified hematology and clinical chemistry laboratory evaluations
Measured: 7 days
Safety Outcome: Number of Participants Reporting Medically Attended AEs (MAAEs)
MAAEs will be assessed in follow up visits/phone calls within 28 days of primary vaccinations with intranasal BW-1014, positive control, and placebo
Measured: 57 days
Safety Outcome: Number of Participants Reporting Serious Adverse Events (SAEs)
SAEs will be assessed by study arm. An adverse event is considered "serious" if it results in death, or a life-threatening AE, or in hospitalization, or in a substantial disruption of the ability to conduct normal life functions, or in a congenital anomaly/birth defect.
Measured: Up to Day 393
Safety Outcome: Number of Participants Reporting Potential Immune-mediated Medical Conditions (PIMMCs)
PIMMCs will be assessed by follow up visits/phone calls following vaccinations with intranasal BW-1014, positive control, and placebo
Measured: Up to Day 393
Safety Outcome: Number of Participants Reporting New Onset Chronic Medical Conditions (NOCMCs)
NOCMCs will be assessed by follow up visits/phone calls following vaccinations with intranasal BW-1014, positive control, and placebo
Measured: Up to Day 393
Safety Outcome: Number of Participants Reporting Local or Systemic Reactions After Second Intranasal Vaccination
Local and systemic reactions will be assessed in the clinic within 1 hour of intranasal BW-1014, positive control, and placebo administration, including visual assessment of nasal passages
Measured: Within one hour of second intranasal vaccination
Safety Outcome: Number of Participants Reporting Solicited Reactions and General AEs After Second Intranasal Vaccination
Solicited reactions and general adverse events were assessed during follow-up visits and telephone contacts within 7 days after the second intranasal vaccination with BW-1014, rH5 control, or placebo
Measured: Day 36, for the preceding 7-day period
Safety Outcome: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher) Within 14 Days of the Second Intranasal Vaccination
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed during follow-up visits within 14 days after the second intranasal vaccination with BW-1014, rH5 control, or placebo.
Measured: Day 43, for the preceding 14-day period
Secondary outcomes (33)
Safety Endpoint: Number of Participants Reporting Local or Systemic Reactions to Intramuscular H5N1 IIV Vaccine
Number and percentage of participants experiencing local or systemic reactions within 1 hour of vaccination with intramuscular H5N1 IIV vaccine
Measured: Day 197
Safety Endpoint: Number of Participants Reporting Solicited Reactions and General AEs
Solicited reactions and general adverse events were assessed within 7 days after intramuscular H5N1 IIV vaccination
Measured: Day 204, for the preceding 7-day period
Safety Endpoint: Number of Participants Reporting Unsolicited AEs
Unsolicited adverse events were assessed within 28 days after intramuscular H5N1 IIV vaccination
Measured: Day 225, for the preceding 28-day period
Safety Endpoint: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher)
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed within 7 days after intramuscular H5N1 IIV vaccination.
Measured: Day 204, for the preceding 7-day period
Safety Endpoint: Number of Participants Reporting Medically Attended AEs (MAAEs)
Medically attended adverse events (MAAEs) were assessed within 28 days after intramuscular H5N1 IIV vaccination
Measured: Day 225, for the preceding 28-day period
Primary Humoral Immune Response Outcome: Serum HI Geometrical Mean Titers Levels at Baseline
Serum H5N1 (clade 2.1) hemagglutination inhibition antibody geometric mean titers (GMTs) were measured in specimens collected on the day of, but prior to the first study vaccination (baseline)
Measured: Baseline
Primary Humoral Immune Response Outcome: Rates of Seroconversion
Serum H5N1 (clade 2.1) hemagglutination inhibition antibody seroconversion rates were assessed 28 days after the second intranasal vaccination (study Day 57). Seroconversion was defined as a pre-vaccination HI titer <1:10 with a post-vaccination HI titer ≥1:40, or a pre-vaccination HI titer ≥1:10 with a minimum four-fold rise in post-vaccination HI antibody titer.
Measured: Day 57 compared to Day 1
Primary Humoral Immune Response Outcome: Serum IgA ELISA Geometric Mean Titer (GMT) at Baseline
Baseline strain-specific serum IgA geometric mean titer (GMT) was measured by ELISA in specimens collected on the day of, but prior to, the first study vaccination
Measured: Baseline
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Baseline
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected on the day of, but prior to, the first study vaccination
Measured: baseline
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Activation Marker (CD69), Cytokines/Chemokines
Vaccine-specific activation marker (CD69) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Activation Marker (CD154), Cytokines/Chemokines
Vaccine-specific activation marker (CD154) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Baseline
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected on the day of, but prior to, the first study vaccination
Measured: baseline
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IFN-gamma
Vaccine-specific TNF-α expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific TNF-α
Vaccine-specific cytokine (TNF-α) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-4
Vaccine-specific IL-4 expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-2
Vaccine-specific cytokine (IL-2) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-10
Vaccine-specific IL-10 expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-21
Vaccine-specific IL-21 expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific CD107a
Vaccine-specific degranulation marker (CD107a) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Granzyme B
Vaccine-specific degranulation marker (Granzyme B) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Effector Memory Cell)
Vaccine-specific effector memory T-cell subsets were assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Central Memory Cell)
Vaccine-specific T-cell memory subset (central memory cell) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Effector Memory CD45RA+ Cell)
Vaccine-specific T-cell memory subset (effector memory CD45RA+ cell) expression was assessed by flow cytometry in cells isolated from nasal lavage specimens collected through study Day 197 following intranasal vaccination
Measured: Up to Day 197
Primary Humoral Immune Response Outcome: Serum H5N1 (Clade 2.1) Hemagglutination Inhibition Geometric Mean Titer (GMT) at Day 57
Serum H5N1 (clade 2.1) hemagglutination inhibition geometric mean titer (GMT) was assessed in specimens collected 28 days after the second intranasal vaccination (study Day 57)
Measured: Day 57
Primary Humoral Immune Response Outcome: Serum IgA ELISA Geometric Mean Titer (GMT) After Both Intranasal Vaccinations
Strain-specific serum IgA geometric mean titer (GMT) was measured by ELISA in specimens collected 28 days after the second intranasal vaccination (study Day 57)
Measured: Day 57
Primary Humoral Immune Response Outcome: Serum IgG ELISA Geometric Mean Titer (GMT) at Baseline
Baseline strain-specific serum IgG geometric mean titer (GMT) was measured by ELISA in specimens collected on the day of, but before, the first study vaccination
Measured: Baseline
Primary Humoral Immune Response Outcome: Serum IgG ELISA Geometric Mean Titer (GMT) at Day 57
Strain-specific serum IgG geometric mean titer (GMT) was measured by ELISA in specimens collected 28 days after the second intranasal vaccination (study Day 57).
Measured: Day 57
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 43
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 14 days after the second intranasal vaccination (study Day 43)
Measured: Day 43
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 57
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 28 days after the second intranasal vaccination (study Day 57)
Measured: Day 57
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 197
Mucosal vaccine-specific IgG geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected immediately before intramuscular H5N1 IIV vaccination (study Day 197)
Measured: Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 43
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 14 days after the second intranasal vaccination (study Day 43)
Measured: Day 43
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 57
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected 28 days after the second intranasal vaccination (study Day 57)
Measured: Day 57
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 197
Mucosal vaccine-specific IgA geometric mean titer (GMT) was measured by ELISA in nasal lavage specimens collected immediately before intramuscular H5N1 IIV vaccination (study Day 197)
Measured: Day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start7 Jul 2022
- Primary completion12 Oct 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive BW-1014 in 3 different dose levels (25 µg, 50 µg or 100 µg rH5 in NE adjuvant), using a pipette dropper. Control arms include rH5 alone (without NE adjuvant) or placebo (saline) control. Since this is first in humans, a dose escalation assessment will take place. A sentinel group of 2 participants from the lowest dose (25 µg rH5 in NE) with 2 rH5 control and 2 placebo control will be dosed first before proceeding to the next dose level. Each escalation of dose will take place after safety clearance of the prior lower dose level. Dosing of the remainder of subjects per dose arm will take place after safety clearance of the corresponding dose sentinel participants.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueWillow Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Justin Ortiz, MD, MS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397119
- Sponsor's protocol ID
- BW-1014-001
- Other IDs
- U01AI148081, 20-0036
- Acronym
- IN-NE-rH5
- Status last verified
- Jul 2026
- First submitted
- 13 May 2022
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deming ME, Toapanta FR, Pasetti M, Golding H, Khurana S, Hamouda T, Fattom A, Liang Y, Tennant SM, McGilvray MF, Bernal PJ, Oshinsky JJ, Datta S, Booth JP, Coughlan L, Neuzil KM, Costley CD, Kotloff KL, Sztein MB, Ortiz JR; rH5 Writing Group. An intranasal adjuvanted, recombinant influenza A/H5 vaccine primes against diverse H5N1 clades: a phase I trial. Nat Commun. 2025 Nov 6;16(1):9321. doi: 10.1038/s41467-025-64686-3.
PubMed 41198655
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05397119
- Acronym / sponsor ID
- IN-NE-rH5 / BW-1014-001
- Conditions
- Influenza, Pandemic
- Keywords
- Pandemic influenza, Nanoemulsion adjuvant, Nasal vaccine, rH5
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BlueWillow BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants will be randomized to receive BW-1014 in 3 different dose levels (25 µg, 50 µg or 100 µg rH5 in NE adjuvant), using a pipette dropper. Control arms include rH5 alone (without NE adjuvant) or placebo (saline) control. Since this is first in humans, a dose escalation assessment will take place. A sentinel group of 2 participants from the lowest dose (25 µg rH5 in NE) with 2 rH5 control and 2 placebo control will be dosed first before proceeding to the next dose level. Each escalation of dose will take place after safety clearance of the prior lower dose level. Dosing of the remainder of subjects per dose arm will take place after safety clearance of the corresponding dose sentinel participants.
| Arm | Type | Receives |
|---|---|---|
| BW-1014: 25 µg rH5 in 20% NE - pipette - IN | Experimental | Biological: BW-1014: 25 µg rH5 in 20% NE - pipette - IN, Biological: H5N1 IIV - IM20% 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 - IN | Experimental | Biological: BW-1014: 50 µg rH5 in 20% NE - pipette - IN, Biological: H5N1 IIV - IM20% 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 - IN | Experimental | Biological: BW-1014: 100 µg rH5 in 20% NE - pipette - IN, Biological: H5N1 IIV - IM20% 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 - IN | Placebo comparator | Biological: rH5 (100 µg) control - pipette - IN, Biological: H5N1 IIV - IM100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart |
| Saline (Placebo) - pipette - IN | Sham comparator | Biological: Saline (Placebo) - pipette - IN, Biological: H5N1 IIV - IMSaline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy men or women aged 18 through 45 years of age, inclusive.
- Women must not be pregnant or nursing. If premenopausal, absence of pregnancy must be confirmed by a negative serum pregnancy test conducted at screening and a negative urine pregnancy test conducted at the site within 24 hours preceding receipt of vaccine.
- Women who are not surgically sterile or at least one year post-menopausal must agree to use acceptable birth control. Acceptable birth control methods include oral, implantable, transdermal or injectable contraceptive; barrier methods such as condoms, cervical caps, or diaphragms with spermicide; abstinence from sexual relationships with a male partner, non-male sexual relationships, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, and other reliable forms of contraception approved by the Investigator. Acceptable birth control must be used for a minimum of 30 days prior to vaccination and for 3 months following final study vaccination.
- Subjects must be in good general health, as determined by medical history and physical examination. Acceptable vital signs and clinical laboratory examinations are within the normal range per study toxicity tables (Appendix B). Vital signs and clinical laboratory examinations meeting Grade 1 criteria may also be acceptable in the opinion of the PI or appropriate Sub-Investigator. For this study, an appropriate Sub-Investigator is a designated clinician licensed to make medical diagnoses and listed on the Form FDA 1572. Exclusionary clinical laboratory examinations may be repeated one time to assess clinical improvement in the event temporary halting criteria (described in Section 8.6.2) are met at the time of the first examination.
- 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.
Key exclusion criteria (24 listed)
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months). This includes signs or symptoms consistent with upper or lower respiratory tract infections.
- Participants with symptoms of COVID-19 and/or who are positive for SARS-CoV-2 by molecular testing conducted within 2 days prevaccination.
- Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
- Receipt of licensed or experimental H5N1 influenza vaccine ever.
- Subjects with a history of chronic cough, frequent sinus infections, sinusitis, allergic rhinitis, nasal polyps or obstruction, including deviated septum significant enough to obstruct the nasal openings or a history of nasal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BW-1014: 25 µg rH5 in 20% NE - pipette - IN20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart | Biological | BW-1014: 25 µg rH5 in 20% NE - pipette - IN |
| BW-1014: 50 µg rH5 in 20% NE - pipette - IN20% Nanoemulsion and 50 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 |
| BW-1014: 100 µg rH5 in 20% NE - pipette - IN20% Nanoemulsion and 100 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 |
| rH5 (100 µg) control - pipette - IN100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart | Biological | rH5 (100 µg) control - pipette - IN |
| Saline (Placebo) - pipette - INSaline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart | Biological | Saline (Placebo) - pipette - IN |
| H5N1 IIV - IM90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization | Biological | BW-1014: 100 µg rH5 in 20% NE - pipette - IN, BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, Saline (Placebo) - pipette - IN, rH5 (100 µg) control - pipette - IN |
Primary outcome
Safety Outcome: Number of Participants Reporting Local or Systemic Reactions After First Intranasal Vaccination
Time frame: Within one hour of first intranasal vaccination
Local and systemic reactions will be assessed in the clinic within 1 hour of intranasal BW-1014, positive control, and placebo administration, including visual assessment of nasal passages
Safety Outcome: Number of Participants Reporting Solicited Reactions and General AEs After First Intranasal Vaccination
Time frame: 7 days
Solicited reactions and general AEs will be assessed in follow up visit/phone call within 7 days of first intranasal vaccination with intranasal BW-1014, positive control and placebo
Safety Objective: Number of Participants Reporting Unsolicited AEs
Time frame: Day 29 and Day 57 (each summarizing unsolicited adverse events occurring during the preceding 28-day period)
Number and proportion of participants reporting unsolicited adverse events within 28 days after each intranasal vaccination with BW-1014, rH5 control, or placebo, assessed at study Days 29 and 57.
Safety Outcome: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher) Within 7 Days of the First Intranasal Vaccination
Time frame: 7 days
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed in follow-up visits within 7 days after the first intranasal vaccination with BW-1014, rH5 control, or placebo using protocol-specified hematology and clinical chemistry laboratory evaluations
Safety Outcome: Number of Participants Reporting Medically Attended AEs (MAAEs)
Time frame: 57 days
MAAEs will be assessed in follow up visits/phone calls within 28 days of primary vaccinations with intranasal BW-1014, positive control, and placebo
Safety Outcome: Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: Up to Day 393
SAEs will be assessed by study arm. An adverse event is considered "serious" if it results in death, or a life-threatening AE, or in hospitalization, or in a substantial disruption of the ability to conduct normal life functions, or in a congenital anomaly/birth defect.
Safety Outcome: Number of Participants Reporting Potential Immune-mediated Medical Conditions (PIMMCs)
Time frame: Up to Day 393
PIMMCs will be assessed by follow up visits/phone calls following vaccinations with intranasal BW-1014, positive control, and placebo
Safety Outcome: Number of Participants Reporting New Onset Chronic Medical Conditions (NOCMCs)
Time frame: Up to Day 393
NOCMCs will be assessed by follow up visits/phone calls following vaccinations with intranasal BW-1014, positive control, and placebo
Safety Outcome: Number of Participants Reporting Local or Systemic Reactions After Second Intranasal Vaccination
Time frame: Within one hour of second intranasal vaccination
Local and systemic reactions will be assessed in the clinic within 1 hour of intranasal BW-1014, positive control, and placebo administration, including visual assessment of nasal passages
Safety Outcome: Number of Participants Reporting Solicited Reactions and General AEs After Second Intranasal Vaccination
Time frame: Day 36, for the preceding 7-day period
Solicited reactions and general adverse events were assessed during follow-up visits and telephone contacts within 7 days after the second intranasal vaccination with BW-1014, rH5 control, or placebo
Safety Outcome: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher) Within 14 Days of the Second Intranasal Vaccination
Time frame: Day 43, for the preceding 14-day period
Hematological and biochemical laboratory abnormalities (Grade 1 or higher) were assessed during follow-up visits within 14 days after the second intranasal vaccination with BW-1014, rH5 control, or placebo.
33 secondary outcomes
Safety Endpoint: Number of Participants Reporting Local or Systemic Reactions to Intramuscular H5N1 IIV Vaccine
Time frame: Day 197
Safety Endpoint: Number of Participants Reporting Solicited Reactions and General AEs
Time frame: Day 204, for the preceding 7-day period
Safety Endpoint: Number of Participants Reporting Unsolicited AEs
Time frame: Day 225, for the preceding 28-day period
Safety Endpoint: Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormality (Grade 1 of Higher)
Time frame: Day 204, for the preceding 7-day period
Safety Endpoint: Number of Participants Reporting Medically Attended AEs (MAAEs)
Time frame: Day 225, for the preceding 28-day period
Primary Humoral Immune Response Outcome: Serum HI Geometrical Mean Titers Levels at Baseline
Time frame: Baseline
Primary Humoral Immune Response Outcome: Rates of Seroconversion
Time frame: Day 57 compared to Day 1
Primary Humoral Immune Response Outcome: Serum IgA ELISA Geometric Mean Titer (GMT) at Baseline
Time frame: Baseline
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Baseline
Time frame: baseline
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Activation Marker (CD69), Cytokines/Chemokines
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Activation Marker (CD154), Cytokines/Chemokines
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Baseline
Time frame: baseline
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IFN-gamma
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific TNF-α
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-4
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-2
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-10
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IL-21
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific CD107a
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific Granzyme B
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Effector Memory Cell)
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Central Memory Cell)
Time frame: Up to Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific T-cell Memory Subset (Effector Memory CD45RA+ Cell)
Time frame: Up to Day 197
Primary Humoral Immune Response Outcome: Serum H5N1 (Clade 2.1) Hemagglutination Inhibition Geometric Mean Titer (GMT) at Day 57
Time frame: Day 57
Primary Humoral Immune Response Outcome: Serum IgA ELISA Geometric Mean Titer (GMT) After Both Intranasal Vaccinations
Time frame: Day 57
Primary Humoral Immune Response Outcome: Serum IgG ELISA Geometric Mean Titer (GMT) at Baseline
Time frame: Baseline
Primary Humoral Immune Response Outcome: Serum IgG ELISA Geometric Mean Titer (GMT) at Day 57
Time frame: Day 57
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 43
Time frame: Day 43
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 57
Time frame: Day 57
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgG Geometric Mean Titer (GMT) at Day 197
Time frame: Day 197
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 43
Time frame: Day 43
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 57
Time frame: Day 57
Primary Mucosal Immunogenicity Outcome: Mucosal Vaccine-specific IgA Geometric Mean Titer (GMT) at Day 197
Time frame: Day 197
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41198655Deming ME, Toapanta FR, Pasetti M, Golding H, Khurana S, Hamouda T, Fattom A, Liang Y, Tennant SM, McGilvray MF, Bernal PJ, Oshinsky JJ, Datta S, Booth JP, Coughlan L, Neuzil KM, Costley CD, Kotloff KL, Sztein MB, Ortiz JR; rH5 Writing Group. An intranasal adjuvanted, recombinant influenza A/H5 vaccine primes against diverse H5N1 clades: a phase I trial. Nat Commun. 2025 Nov 6;16(1):9321. doi: 10.1038/s41467-025-64686-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Ortiz, MD, MS principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN and BW-1014: 100 µg rH5 in 20% NE - pipette - IN in people with Influenza, Pandemic, run by BlueWillow Biologics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome: Number of Participants Reporting Local or Systemic Reactions After First Intranasal Vaccination (time frame: Within one hour of first intranasal vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.