Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
Condition: Influenza
Intervention: NasoVAX
Intervention description: Single ascending dose study
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose study
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety
      and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be
      screened within 28 days of randomization (Day 1).
    

Eligibility criteria:

        Subjects who meet all of the following criteria may be included in the study:

          1. Men and women 18 to 49 years of age, inclusive

          2. Good general health status as determined by the Investigator

          3. Adequate venous access for repeated phlebotomies

          4. Screening laboratory results within institutional normal range or Grade 1 elevation if
             the Investigator documents clinical insignificance. Creatine kinase or bilirubin may
             be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) and the Investigator considers the result not to be clinically
             significant due to vigorous exercise or Gilbert's syndrome

          5. Negative drug and alcohol screen at Screening and predose on Day 1

          6. For women who have not been surgically sterilized or have laboratory confirmation of
             postmenopausal status, negative pregnancy test

          7. Willingness to practice a highly effective method of contraception that may include,
             but is not limited to, abstinence, sex only with persons of the same sex, monogamous
             relationship with a postmenopausal partner, monogamous relationship with vasectomized
             partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation,
             salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD),
             or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28
             days after the NasoVAX/placebo dose

          8. Willingness to participate and comply with all aspects of the study through the entire
             study period, including nasopharyngeal swabs and blood and urine samples

          9. Provision of written informed consent

        Subjects who meet any of the following criteria will be excluded from the study:

          1. Pregnant, possibly pregnant, or lactating women

          2. Household contacts of pregnant women, children < 5 years of age, or immunocompromised
             individuals for the period up through 2 weeks postvaccination

          3. Persons who care for pregnant women, children < 5 years of age, or immunocompromised
             individuals for the period up through 2 weeks postvaccination

          4. Body mass index > 35.0 kg/m2

          5. Positive results for HIV, hepatitis B virus, or hepatitis C virus at Screening

          6. Asthma or other chronic lung disease that is greater than mild in severity.
             Specifically excluded are participants with the any of the following events in the
             past year:

               -  Daily symptoms

               -  Daily use of short acting beta 2 agonists

               -  Use of inhaled steroids or theophylline

               -  Use of pulse systemic steroids

               -  Emergency care or hospitalization related to asthma or other chronic lung disease

               -  Systemic steroids for asthma exacerbation

          7. History of diabetes mellitus (gestational diabetes is allowed if treatment was not
             required postpartum and serum glucose is currently in the normal range)

          8. History of coronary artery disease, arrhythmia, or congestive heart failure

          9. Clinically significant ECG abnormality as determined by the Investigator

         10. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood
             pressure > 95 mmHg) at Screening or predose on Day 1

         11. History of anaphylaxis or angioedema

         12. Known allergy to any of the ingredients in the vaccine formulation

         13. History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other
             nasal abnormality that might affect vaccine administration

         14. Previous nasal surgery or nasal cauterization

         15. Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before
             Day 1

         16. Any symptoms within 24 hours before Day 1 of upper respiratory illness of allergy
             flare-up that, in the opinion of the Investigator, presents as nasal congestion or
             rhinorrhea that could inhibit the proper administration of the IP

         17. Known or suspected malignancy, excluding non-melanoma skin cancers and other early
             stage surgically excised malignancies that the Investigator considers to be
             exceedingly unlikely to recur

         18. Immunocompromised individuals, including those who have used corticosteroids
             (including intranasal steroids), alkylating drugs, antimetabolites, radiation,
             immune-modulating biologics, or other immunomodulating therapies within 90 days before
             Day 1 or those who plan use during the study period

         19. Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1)

         20. Receipt of intranasal medications (including over-the-counter medications) within 30
             days before Day 1

         21. Receipt of any investigational product (IP) within 30 days before Day 1

         22. Receipt of any vaccine within 30 days before Day 1

         23. Receipt of intranasal vaccine within 90 days before Day 1

         24. Receipt of any influenza vaccine within 6 months before Day 1

         25. Any change in medication for a chronic medical condition within 30 days before Day 1

         26. Past regular use or current use of intranasal illicit drugs

         27. Smoking of any type (eg, cigarettes, electronic cigarettes, marijuana) or use of any
             tobacco product within 30 days before Day 1

         28. Any medical, psychiatric, or social condition or occupational or other responsibility
             that in the judgment of the Investigator would interfere with or serve as a
             contraindication to protocol adherence, assessment of safety (including
             reactogenicity), or a subject's ability to give informed consent