AnthraxPhase 1IN NE-rPANCT04148118

A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults

A Phase 1 study testing BW-1010: 50 µg - sprayer - IN, BW-1010: 50 µg - pipette - IN and BW-1010: 100 µg - sprayer - IN in people with Anthrax, run by BlueWillow Biologics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1010. BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to anthrax. The vaccine will be administered intranasally (IN) to healthy adults, age 18 - 49. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Anthrax
What is being tested?: BW-1010: 50 µg - sprayer - IN, BW-1010: 50 µg - pipette - IN and BW-1010: 100 µg - sprayer - IN
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteUnited States
Study dates: 8 Jan 2020to 2 Sep 2021
Phase: Phase 1
Are there results?: None posted in the registry

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 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Between 18 to 49 years of age, inclusive.
Female of child-bearing potential, must be non-lactating and non-pregnant as confirmed by a negative serum pregnancy test conducted at screening and a negative urine pregnancy test conducted at the site within 24 hours preceding each receipt of vaccine.
Females should be either:
Surgically sterile. Surgical sterilization includes hysterectomy, bilateral salpingectomy, tubal ligation or successful other permanent sterilization methods such as Essure® placement with documented confirmation test at least 3 months after the procedure, or
At least one year post-menopausal, or
Agree to use highly effective hormonal contraceptive method defined by a <1% failure rate that is not affected by adherence such as progestin releasing subdermal implants, or levonorgestrel releasing IUDs, for a minimum of 30 days prior to immunization and for 3 months following the last immunization. Concurrent use of a barrier method of birth control is not required. or

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If using a moderately effective contraceptive method defined by a 5-9% failure rate per year with typical use, such as the pill, hormone releasing transdermal patch or ring, or Progestin-only Injectable Contraceptive (DMPA) injections. Concurrent use of a barrier method of contraception is required. or
Have acceptable sexual abstinence as defined by refraining from heterosexual intercourse for a minimum of 30 days prior to immunization and a credible intent to continue to do so until 3 months following the last immunization. The reliability of sexual abstinence will be to be evaluated in relation to the preferred and usual lifestyle of the subject.
Males must agree to use condoms from screening through 3 months following the last immunization, unless vasectomized.
Males must not donate sperm from screening through 3 months following the last immunization.
Are healthy, as determined by medical history, physical examination, vital signs, and clinical laboratory examinations. Healthy participants have no chronic medical conditions and no acute medical conditions that required the use of systemic prescription medications in the last 30 days or 5 half-lives, whichever is longer.
Comprehends the study requirements, is available for the required study period, and is able to attend scheduled visits.
Has given written informed consent to participate in the study.

Who cannot join

Presence of significant acute illness or any chronic medical condition.
Presence of psychiatric illness, currently untreated or clinically unstable (in the opinion of the PI) schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with participant compliance or safety evaluations.
Participants with a history of chronic cough, reactive airway disease, asthma, chronic obstructive pulmonary disease (COPD), frequent sinus infections, sinusitis, allergic rhinitis, nasal polyps or obstruction, including deviated septum or other major nasopharyngeal anatomic abnormalities significant enough to obstruct the nasal openings, are to be excluded. Participants with seasonal rhinitis may be included if their 'season' does not occur within 3 months of the immunization date and they are not currently receiving intranasal steroids.
History of natural anthrax infection.
Receipt of any licensed or experimental anthrax vaccine at any time in the participant's lifetime.
The participant or an immediate household member is meeting criteria for which receipt of licensed anthrax vaccine is recommended or expected including:

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Exposure to animal products such as hides, hair, or bones which come from anthrax endemic areas and may be contaminated with Bacillus anthracis spores.
Engagement in diagnostic or investigational activities which may result in contact with B. anthracis spores.
Holding of a position such as veterinarians and others handling potentially infected animals.
Military personnel for whom immunization with anthrax vaccine is required.
Positive serology for HIV-1 or HIV-2, or HCV antibodies.
Platelet count <150,000/mm3.
Fever >100.4°C within one week of immunization; this is considered as a temporary exclusion, as an otherwise eligible participant may be immunized once the fever has resolved. Participants must remain within the screening window or be rescreened if >30 days elapses prior to enrollment.
History of aspiration, dysphagia, swallowing disorders, stroke or other neurologic conditions that may predispose the participant to aspiration of test articles into the respiratory tract.
History of Bell's palsy.
Cancer or treatment for cancer, within 3 years. Participants with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Participants with basal cell carcinoma or squamous cell carcinoma are allowed, unless present on or near the nose.
Impaired immune responsiveness, regardless of cause, including diabetes mellitus.
Known or suspected active chronic autoinflammatory condition
Presently receiving or a history of receiving any medications or treatments that affect the immune system such as immunoglobulin, interferon, immuno-modulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past six (6) months.
Chronic use of inhaled or intranasal sprays including decongestants and corticosteroids; chronic use of these products is prohibited during the first 12 weeks of the study.
Presently a vaper, smoker or tobacco user or with a history of vaping, smoking or tobacco use within the past year prior to screening.
Receipt or planned administration of a non-study vaccine within 30 days of screening or 60 days after the initiation of the study. Immunization on an emergency basis such as with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) upon exposure will be allowed. Administration of study vaccine can be delayed if a non-study vaccine has been administered and will be given as soon as acceptable, as described above.
Known allergy to any vaccine component.
History of allergic and/or anaphylactic type reaction to tetracycline-based drugs, injected vaccines, or to any of the components of BW-1010 [soybean oil, dehydrated alcohol (anhydrous ethanol), polysorbate 80 (Tween 80) and, Cetylpyridinium chloride (CPC)], or any of the BioThrax components (aluminium, benzethonium chloride, or formaldehyde).
History of drug or chemical abuse in the year before the study.
Receipt of any investigational product or nonregistered drug within the 30 days of screening, or currently enrolled in any investigational drug study, or intends to enroll in such a study within the ensuing 12 month period.
Use of nasally administered prescription or nasally administered over-the-counter (OTC) medications within seven (7) days before immunization.
Receipt of blood or blood products eight (8) weeks before study entry or planned receipt within the ensuing 12 month period.
Donation of blood or blood products within eight (8) weeks before screening or planned donation within the ensuing Week 12 visit.
Acute disease within a week prior to immunization, defined as the presence of a moderate or severe illness (as determined by the PI through medical history and physical examination) with or without fever. For participants with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness, the participant can be re-screened once they have completely recovered.
Any condition that, in the opinion of the PI, might interfere with study objectives.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johnson County Clin-Trial
Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: A Phase 1 Randomized, Observer-Blind, Active- and Placebo-Controlled Dose Comparison, Safety, Tolerability and Immunogenicity Study of Intranasal Adjuvanted Anthrax Vaccine (BW-1010; rPA + 20%W805EC) in Healthy Adult Volunteers Administered by Nasal Sprayer and Pipette With an Additional Unblinded Positive Control Arm

The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1010.

BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to anthrax.

The vaccine will be administered intranasally (IN) to healthy adults, age 18 - 49.

The study will be conducted in 84 volunteers in one center in the United States.

The study will compare 2 different dose levels of rPA (50µg and 100µg rPA), and 2 different administration methods (a sprayer and dropper) with a negative control (saline) and a positive control (the injectable BioThrax licensed vaccine).

The vaccines and negative controls will be administered in 2 IN doses (4 weeks apart). The positive control will be 3 subcutaneous doses, 2 weeks apart. All volunteers will be observed for 1 year after the last dose.

Immunological outcome studied will be from the serum, blood cells and nasal washes.

Read the detailed description

This study is a single center, randomized, observer-blind, active- and placebo-controlled, dose comparison study to assess the safety, tolerability and immunogenicity of BW-1010 administered IN using an Aptar Bidose sprayer or an Eppendorf Electronic Repeater pipette in healthy adult volunteers. There is an additional unblinded BioThrax arm administered by SC injection. BioThrax is included in the study design only to provide a licensed, active control for immunogenicity and safety comparisons. A total of 84 participants will be enrolled in the study. Participants will be randomized in one of the following 7 arms:

BW-1010: 50µg - sprayer - IN, 400 µL; 16 participants.
BW-1010: 50µg - pipette - IN, 400 µL; 16 participants.
BW-1010: 100µg - sprayer - IN, 400 µL; 16 participants.
BW-1010: 100µg - pipette - IN, 400 µL; 16 participants.
Saline (Placebo) - sprayer - IN, 400 µL; 6 participants.
Saline (Placebo) - pipette - IN, 400 µL; 6 participants.
BioThrax (Positive control) - SC, 500 µL; 8 participants.

All participants receiving test article or placebo will receive two doses of the vaccine four weeks apart. Each of these participants will receive treatment intranasally using either an Aptar Bidose sprayer or an Eppendorf Electronic Repeater pipette. Eight participants will be randomized to receive a positive control (BioThrax vaccine) and will receive 3 doses of vaccine two weeks apart.

Since this is the first-in-human study for BW-1010, a total of twelve sentinel participants will receive either the test article or the placebo in a randomized fashion prior to dosing the main participants. Four of the 50 µg rPA vaccine and two placebo control participants will be randomized and dosed first, with no more than one participant/day with at least 24 hours safety follow up prior to enrolling the next participant. The Safety Review Committee (SRC) will review all safety data available through the Day 8 visit of the last sentinel participant dosed from this group and provide clearance to proceed with the 50 µg rPA Main Study participants and the 100 µg sentinel group. Four of the 100 µg rPA vaccine Sentinel Group and two placebo control participants will be randomized and dosed after safety clearance of the 50 µg rPA sentinel group, with no more than one participant/day with at least 24 hours safety follow up prior to enrolling the next participant. The SRC will review all safety data available through the Day 8 visit of the last sentinel participant dosed from this group and provide clearance to proceed with the 100 µg rPA Main Study participants.

Participants will be followed up for safety and tolerability for 1 year following last immunization.

Participants will be assessed for production of specific antibodies in the form of serum toxin neutralization antibodies (TNA) and serum anti-rPA IgG throughout the study until the termination visit.

Since this is a nasal vaccine and it is anticipated that the immune response will be different that the standard parental vaccines, the participants will be tested 10 days post last dose for rPA-specific cytokine on T-cells (IFN-ɤ, IL-5 and IL-17) and rPA-specific IgG and Ig-A on B-cells. Nasal wash will also be tested for total IgA and rPA-specific IgG and IgA.

Safety and immunogenicity analysis will include all randomized participants. Analysis will compare the different dose levels, different method of administration. Participants who received BW-1010 will be compared to participants who received the saline negative control and the BioThrax positive control.

COVID-19 Shut Down Impact on the Clinical Trial:

After the majority of the 50µg subjects had received only 1 of the 2 planned immunization, the Covid-19 pandemic stay-at-home order was instated and they could not receive their 2nd immunization. As a result of this, after COVID shut down was released, subjects involved in the clinical trial were divided into 2 Cohorts:

Cohort 1: Subjects from the Sentinel and 50µg main groups who received 2 or 1 immunizations prior to COVID-19 stay-at-home restrictions. Except for COVID-interrupted visits, these subjects will continue safety assessment at their their originally planned visits. Due to incomplete immunization schedule, no immunological testing will be performed.
Cohort 2: These are the subjects who were not enrolled prior to the Covid-19 impacts. In order to maintain enough power to detect critical safety issues in the clinical trial, these remaining 43 subjects will be randomized to receive the 100 µg rPA dose or placebo (either by pipette or sprayer) or BioThrax. No additional 50 µg rPA subjects will be dosed. These 43 subjects will follow the original study plan:
Immunization at Week 0 and Week 4 (+ Week 2 for BioThrax).
Follow up on Weeks 1, 5.5, 8, 12, 28 and 56 for safety and immunogenicity.

Conditions: Anthrax
Being tested: BW-1010: 50 µg - sprayer - IN, BW-1010: 50 µg - pipette - IN, BW-1010: 100 µg - sprayer - IN, BW-1010: 100 µg - pipette - IN, Saline (Placebo) - sprayer - IN
Keywords: Anthrax, Nanoemulsion adjuvant, Nasal Vaccine, Recombinant Protective Antigen
Medical subject headings: Anthrax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BW-1010: 50 µg - sprayer - INBiological
20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL).
Two doses administered 4 weeks apart.
BW-1010: 50 µg - pipette - INBiological
20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by pipette (400µL).
Two doses administered 4 weeks apart.
BW-1010: 100 µg - sprayer - INBiological
20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL)
Two doses administered 4 weeks apart
BW-1010: 100 µg - pipette - INBiological
20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by pipette (400µL).
Two doses administered 4 weeks apart.
Saline (Placebo) - sprayer - INBiological
Saline (negative control) administered intranasally by Aptar Bidose Sprayer (400µL).
Two doses administered 4 weeks apart.
Saline (Placebo) - pipette - INBiological
Saline (negative control) administered intranasally by pipette (400µL).
Two doses administered 4 weeks apart.
BioThrax (positive control) - SCBiological
BioThrax licensed vaccine administered subcutaneously (500µL).
Three doses administered 2 weeks apart.

Study groups in NCT04148118
Study group	Role	What they receive
NE+50µg rPA - sprayer	Experimental	Not described Receives: Biological: BW-1010: 50 µg - sprayer - IN
NE+50µg rPA - pipette	Experimental	Not described Receives: Biological: BW-1010: 50 µg - pipette - IN
NE+100µg rPA - sprayer	Experimental	Not described Receives: Biological: BW-1010: 100 µg - sprayer - IN
NE+100µg rPA - pipette	Experimental	Not described Receives: Biological: BW-1010: 100 µg - pipette - IN
Saline - sprayer	Placebo comparator	Not described Receives: Biological: Saline (Placebo) - sprayer - IN
Saline - pipette	Placebo comparator	Not described Receives: Biological: Saline (Placebo) - pipette - IN
BioThrax - SC	Active comparator	Not described Receives: Biological: BioThrax (positive control) - SC

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Objectives: Frequency of solicited systemic and local reactions (reactogenicity and tolerability) reported after each immunization
This will be conducted throughout the 2 hours in-clinic observation following each immunization, during the follow up Safety Phone Call conducted 1-3 days post immunization, during the review of the Symptom Diary Reminder Card that will be distributed to participants following immunization and during the 7 to 10 day visit following each immunization.
Measured: Up to Day 39 scheduled visit.
Safety Objectives: Frequency of Adverse Events (AE)
All treatment-emergent AEs will be summarized. These are AEs beginning or worsening after the initiation of the first immunization. These including any clinical laboratory abnormalities.
Measured: Up to Day 85 scheduled visit.
Safety Objectives: Frequency of Serious Adverse Events (SAEs)
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 scheduled visit.
Primary Immunogenicity Objectives: Assess and compare the increase in rPA neutralizing antibodies following the different interventions in Cohort 2 subjects.
Use serum Toxin Neutralizing Assay (TNA) to compare immune response in the rPA 100 µg dose between the two different methods of administration (Aptar Bidose sprayer and Eppendorf Electronic Repeater pipette) of BW-1010 and compare them with the positive control arm receiving BioThrax.
Measured: Day 57 and Day 85 (co-primary end point). The two time points will be compared to identify the optimum timing of peak immuneresponse following nasal vaccination.

Secondary outcomes (1)

Secondary Immunogenicity Objectives: Assess and compare the increase in anti-rPA antibodies following the different interventions in Cohort 2 subjects.
Use serum anti-rPA (ELISA) to compare immune response in the rPA 100 µg dose between two different methods of administration (Aptar Bidose sprayer and Eppendorf Electronic Repeater pipette) of BW-1010 and compare them with the positive control arm receiving BioThrax.
Measured: Day 57 and Day 85.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 20202 Sep 2021

First posted1 Nov 2019
Study start8 Jan 2020
Primary completion2 Sep 2021
Study completion2 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnthraxStudies 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-1010 in 2 different dose levels (50 µg or 100 µg rPA), using 2 different method of administration (Aptar sprayer or pipette dropper). Negative control participants (Placebo) will receive saline using the 2 different methods as well. The positive control participants will receive BioThrax subcutaneously. Since this is first in humans, a sentinel group, 4 participants with the smaller dose level (50 µg rPA) and 2 placebos, will be dosed first. The main group of the 50 µg rPA and the higher level rPA sentinels will dosed after day 8 safety clearance of the low dose rPA sentinel participants.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04148118
Sponsor's protocol ID: BW1010-001
Other IDs: HHSN272201600045C, 16-0111
Acronym: IN NE-rPA
Status last verified: May 2022
First submitted: 28 Oct 2019
Last updated: 18 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Randomized, Observer-Blind, Active- and Placebo-Controlled Dose Comparison, Safety, Tolerability and Immunogenicity Study of Intranasal Adjuvanted Anthrax Vaccine (BW-1010; rPA + 20%W805EC) in Healthy Adult Volunteers Administered by Nasal Sprayer and Pipette With an Additional Unblinded Positive Control Arm
ClinicalTrials.gov ID: NCT04148118
Acronym / sponsor ID: IN NE-rPA / BW1010-001
Conditions: Anthrax
Keywords: Anthrax, Nanoemulsion adjuvant, Nasal Vaccine, Recombinant Protective Antigen
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: BlueWillow BiologicsIndustry (pharma, biotech, devices)
Collaborators: Porton Biopharma Ltd.
Study start: 8 Jan 2020 (actual)
Primary completion: 2 Sep 2021 (actual)
Study completion: 2 Sep 2021 (actual)
First posted: 1 Nov 2019 (actual)
Results: Not posted in the source record

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-1010.

BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to anthrax.

The vaccine will be administered intranasally (IN) to healthy adults, age 18 - 49.

The study will be conducted in 84 volunteers in one center in the United States.

Immunological outcome studied will be from the serum, blood cells and nasal washes.

Detailed description

BW-1010: 50µg - sprayer - IN, 400 µL; 16 participants.
BW-1010: 50µg - pipette - IN, 400 µL; 16 participants.
BW-1010: 100µg - sprayer - IN, 400 µL; 16 participants.
BW-1010: 100µg - pipette - IN, 400 µL; 16 participants.
Saline (Placebo) - sprayer - IN, 400 µL; 6 participants.
Saline (Placebo) - pipette - IN, 400 µL; 6 participants.
BioThrax (Positive control) - SC, 500 µL; 8 participants.

Participants will be followed up for safety and tolerability for 1 year following last immunization.

Participants will be assessed for production of specific antibodies in the form of serum toxin neutralization antibodies (TNA) and serum anti-rPA IgG throughout the study until the termination visit.

COVID-19 Shut Down Impact on the Clinical Trial:

Cohort 1: Subjects from the Sentinel and 50µg main groups who received 2 or 1 immunizations prior to COVID-19 stay-at-home restrictions. Except for COVID-interrupted visits, these subjects will continue safety assessment at their their originally planned visits. Due to incomplete immunization schedule, no immunological testing will be performed.
Cohort 2: These are the subjects who were not enrolled prior to the Covid-19 impacts. In order to maintain enough power to detect critical safety issues in the clinical trial, these remaining 43 subjects will be randomized to receive the 100 µg rPA dose or placebo (either by pipette or sprayer) or BioThrax. No additional 50 µg rPA subjects will be dosed. These 43 subjects will follow the original study plan:
Immunization at Week 0 and Week 4 (+ Week 2 for BioThrax).
Follow up on Weeks 1, 5.5, 8, 12, 28 and 56 for safety and immunogenicity.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7
Model description: Participants will be randomized to receive BW-1010 in 2 different dose levels (50 µg or 100 µg rPA), using 2 different method of administration (Aptar sprayer or pipette dropper). Negative control participants (Placebo) will receive saline using the 2 different methods as well. The positive control participants will receive BioThrax subcutaneously. Since this is first in humans, a sentinel group, 4 participants with the smaller dose level (50 µg rPA) and 2 placebos, will be dosed first. The main group of the 50 µg rPA and the higher level rPA sentinels will dosed after day 8 safety clearance of the low dose rPA sentinel participants.

Arm	Type	Receives
NE+50µg rPA - sprayer	Experimental	Biological: BW-1010: 50 µg - sprayer - IN
NE+50µg rPA - pipette	Experimental	Biological: BW-1010: 50 µg - pipette - IN
NE+100µg rPA - sprayer	Experimental	Biological: BW-1010: 100 µg - sprayer - IN
NE+100µg rPA - pipette	Experimental	Biological: BW-1010: 100 µg - pipette - IN
Saline - sprayer	Placebo comparator	Biological: Saline (Placebo) - sprayer - IN
Saline - pipette	Placebo comparator	Biological: Saline (Placebo) - pipette - IN
BioThrax - SC	Active comparator	Biological: BioThrax (positive control) - SC

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Between 18 to 49 years of age, inclusive.
Female of child-bearing potential, must be non-lactating and non-pregnant as confirmed by a negative serum pregnancy test conducted at screening and a negative urine pregnancy test conducted at the site within 24 hours preceding each receipt of vaccine.
Females should be either:
Males must agree to use condoms from screening through 3 months following the last immunization, unless vasectomized.
Males must not donate sperm from screening through 3 months following the last immunization.

Key exclusion criteria (31 listed)

Presence of significant acute illness or any chronic medical condition.
Presence of psychiatric illness, currently untreated or clinically unstable (in the opinion of the PI) schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with participant compliance or safety evaluations.
Participants with a history of chronic cough, reactive airway disease, asthma, chronic obstructive pulmonary disease (COPD), frequent sinus infections, sinusitis, allergic rhinitis, nasal polyps or obstruction, including deviated septum or other major nasopharyngeal anatomic abnormalities significant enough to obstruct the nasal openings, are to be excluded. Participants with seasonal rhinitis may be included if their 'season' does not occur within 3 months of the immunization date and they are not currently receiving intranasal steroids.
History of natural anthrax infection.
Receipt of any licensed or experimental anthrax vaccine at any time in the participant's lifetime.

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-1010: 50 µg - sprayer - IN20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL). Two doses administered 4 weeks apart.	Biological	NE+50µg rPA - sprayer
BW-1010: 50 µg - pipette - IN20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.	Biological	NE+50µg rPA - pipette
BW-1010: 100 µg - sprayer - IN20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL) Two doses administered 4 weeks apart	Biological	NE+100µg rPA - sprayer
BW-1010: 100 µg - pipette - IN20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.	Biological	NE+100µg rPA - pipette
Saline (Placebo) - sprayer - INSaline (negative control) administered intranasally by Aptar Bidose Sprayer (400µL). Two doses administered 4 weeks apart.	Biological	Saline - sprayer
Saline (Placebo) - pipette - INSaline (negative control) administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.	Biological	Saline - pipette
BioThrax (positive control) - SCBioThrax licensed vaccine administered subcutaneously (500µL). Three doses administered 2 weeks apart.	Biological	BioThrax - SC

Primary outcome

Safety Objectives: Frequency of solicited systemic and local reactions (reactogenicity and tolerability) reported after each immunization
Time frame: Up to Day 39 scheduled visit.
This will be conducted throughout the 2 hours in-clinic observation following each immunization, during the follow up Safety Phone Call conducted 1-3 days post immunization, during the review of the Symptom Diary Reminder Card that will be distributed to participants following immunization and during the 7 to 10 day visit following each immunization.
Safety Objectives: Frequency of Adverse Events (AE)
Time frame: Up to Day 85 scheduled visit.
All treatment-emergent AEs will be summarized. These are AEs beginning or worsening after the initiation of the first immunization. These including any clinical laboratory abnormalities.
Safety Objectives: Frequency of Serious Adverse Events (SAEs)
Time frame: Up to Day 393 scheduled visit.
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.
Primary Immunogenicity Objectives: Assess and compare the increase in rPA neutralizing antibodies following the different interventions in Cohort 2 subjects.
Time frame: Day 57 and Day 85 (co-primary end point). The two time points will be compared to identify the optimum timing of peak immuneresponse following nasal vaccination.
Use serum Toxin Neutralizing Assay (TNA) to compare immune response in the rPA 100 µg dose between the two different methods of administration (Aptar Bidose sprayer and Eppendorf Electronic Repeater pipette) of BW-1010 and compare them with the positive control arm receiving BioThrax.

1 secondary outcome

Secondary Immunogenicity Objectives: Assess and compare the increase in anti-rPA antibodies following the different interventions in Cohort 2 subjects.
Time frame: Day 57 and Day 85.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 31 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 18 May 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Objectives: Frequency of solicited systemic and local reactions (reactogenicity and tolerability) reported after each immunization (time frame: Up to Day 39 scheduled visit.). The study lists 4 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 NCT04148118.

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 18 May 2022.