Eligibility Details:
Inclusion Criteria:
1. Between 18 to 49 years of age, inclusive.
2. 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.
3. Females should be either:
1. 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
2. At least one year post-menopausal, or
3. 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
4. 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
5. 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.
4. Males must agree to use condoms from screening through 3 months following the last
immunization, unless vasectomized.
5. Males must not donate sperm from screening through 3 months following the last
immunization.
6. 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.
7. Comprehends the study requirements, is available for the required study period, and is
able to attend scheduled visits.
8. Has given written informed consent to participate in the study.
Exclusion Criteria:
1. Presence of significant acute illness or any chronic medical condition.
2. 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.
3. 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.
4. History of natural anthrax infection.
5. Receipt of any licensed or experimental anthrax vaccine at any time in the
participant's lifetime.
6. The participant or an immediate household member is meeting criteria for which receipt
of licensed anthrax vaccine is recommended or expected including:
1. Exposure to animal products such as hides, hair, or bones which come from anthrax
endemic areas and may be contaminated with Bacillus anthracis spores.
2. Engagement in diagnostic or investigational activities which may result in
contact with B. anthracis spores.
3. Holding of a position such as veterinarians and others handling potentially
infected animals.
4. Military personnel for whom immunization with anthrax vaccine is required.
7. Positive serology for HIV-1 or HIV-2, or HCV antibodies.
8. Platelet count <150,000/mm3.
9. 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.
10. 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.
11. History of Bell's palsy.
12. 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.
13. Impaired immune responsiveness, regardless of cause, including diabetes mellitus.
14. Known or suspected active chronic autoinflammatory condition
15. 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.
16. 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.
17. Presently a vaper, smoker or tobacco user or with a history of vaping, smoking or
tobacco use within the past year prior to screening.
18. 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.
19. Known allergy to any vaccine component.
20. 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).
21. History of drug or chemical abuse in the year before the study.
22. 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.
23. Use of nasally administered prescription or nasally administered over-the-counter
(OTC) medications within seven (7) days before immunization.
24. Receipt of blood or blood products eight (8) weeks before study entry or planned
receipt within the ensuing 12 month period.
25. Donation of blood or blood products within eight (8) weeks before screening or planned
donation within the ensuing Week 12 visit.
26. 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.
27. Any condition that, in the opinion of the PI, might interfere with study objectives.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
