Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults

Exclusion Criteria

• •1. Pregnancy as determined by a positive human choriogonadotropin (ßHCG) test in a person of reproductive capacity.
• •2. Currently breastfeeding.
• •3. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, electrocardiogram (EKG), and/or laboratory studies.
• •4. Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
• •5. A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with exercise, seasonal hay fever or allergic rhinitis.
• •6. Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation.
• •7. Use of systemic or nasal steroid preparations or immunosuppressive drugs within 30 days prior to vaccination. Topical steroid preparations are permitted.
• •8. Inhaled bronchodilator or inhaled steroid use within the last year or use after upper respiratory tract infections within the last 5 years.
• •9. Current or past (in the last 4 weeks) use of intranasal medications (including steroids, decongestants, or hormonal medications), or planning to use them within 28 days of study vaccination.
• •10. Evidence of current alcohol or illicit drug abuse or addiction.
• •11. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
• •12. Positive ELISA and confirmatory tests for human immunodeficiency virus (HIV).
• •13. Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV).
• •14. Positive hepatitis B virus surface antigen (HBsAg) by ELISA.
• •15. Known immunodeficiency syndrome.
• •16. Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to receipt of the study vaccine or planned receipt within 90 days after vaccination. (Exception, influenza vaccine may be obtained more than 2 weeks after or prior to the study vaccine).
• •17. History of a surgical splenectomy.
• •18. Receipt of blood or blood-derived products (including immunoglobulin \[Ig\]) within 6 months prior to study inoculation.
• •19. Has participated in another investigational study involving any investigational product within 30 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
• •20. Body mass index (BMI) \< 18.5 or \>40.
• •21. Any significant abnormality of the nose or nasopharynx, including recurrent epistaxis and including nasal or sinus surgery.
• •22. History of Bell's palsy.
• •23. Has a confirmed SARS-CoV-2 infection or COVID-19 vaccine/booster within 16 weeks prior to enrollment.
• •24. Unwillingness to have nasopharyngeal (NP) or blood samples saved for future respiratory virus research.
• •25. Pulmonary function test (PFT) testing for FVC, FEV1, FEV1% and PEF of \<80 or incentive spirometer value \< normal parameters based on gender, age, and height.