Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults

Inclusion Criteria

Subjects eligible to participate in this study must meet all inclusion criteria:

• Provide written informed consent prior to initiation of any study procedures.
• Able to understand and comply with planned study procedures and be available for all study visits.
• Males or non-pregnant females, 18-49 years of age, inclusive.
• In good health*.

*As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days that would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days. This includes no change in chronic prescription medication, dose, or frequency because of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, if it is in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes after enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical and inhaled medications (with the exception of inhaled or nasal corticosteroids within 30 days prior to enrollment), herbals, vitamins, and supplements are permitted.

• Oral temperature is / = 20 IU/mL and / or PRN serum IgG antibodies > / = 125 IU/ml.
• Unwilling to refrain from smoking tobacco for 28 days post vaccination.
• Receipt of immunoglobulin or blood derived products within 90 days of enrollment.
• Receipt of a vaccine against pertussis in the past 2 years.
• Receipt of a live vaccine within 30 days of study vaccination or an inactivated vaccine within 14 days of study vaccination.
• Planned vaccination with a licensed vaccine within 28 days of study vaccination.
• History of severe allergic reaction (e.g., anaphylaxis) or Bell's palsy, or Guillain-Barre syndrome, after a previous dose of any diphtheria toxoid-tetanus toxoid-, or pertussis-containing vaccine, or encephalopathy within 7 days of administration of a previous pertussis containing vaccine.
• History of a progressive neurologic disorder.
• In close contact* with children less than 1 year of age or contact with persons with known immunocompromising conditions.

*Close contact includes sharing a household, serving as a healthcare worker, or working professionally in settings with repeated exposures.

• Receipt of B. pertussis-active antibiotics* within 7 days prior to vaccination.

*B. pertussis active antibiotics include macrolides, fluoroquinolones, trimethoprim-sulfamethoxazole, tetracyclines.

• Known hypersensitivity to any component of the study vaccine.
• Hypersensitivity to azithromycin, which may be used in the event of ongoing BPZE1 colonization.
• Any condition that, in the opinion of the investigator, might interfere with objectives of the study or safety to the individual.
• Acute illness, including temperature > 100 degrees Fahrenheit within one week prior to vaccination*.
• Enrollment may be postponed if a