Immune Response Following Seasonal Influenza Vaccination
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Licensed seasonal influenza vaccine
Intervention description: 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Seasonal

Summary:

      This is an open-label, single administration dose study in adult healthy male and female
      subjects. After qualifying for the study, subjects will receive a single intramuscular
      injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women 18 to 50 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. Bilirubin may be Grade 2 if
             associated with no1mal alanine aminotransferase (ALT) and aspartate aminotransferase
             (AST) and the Investigator considers the result not to be clinically significant (e.g.
             vigorous exercise or Gilbert's syndrome)

          5. Negative drug and alcohol screen at Screening and pre-dose on Day I

          6. For women of child bearing potential, 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 (e.g., condom, diaphragm) with spermicide for 28
             days after the Fluzone Intramuscular Quadrivalent vaccine dose.

        Exclusion Criteria:

          1. Pregnant, possibly pregnant, or lactating women

          2. Body mass index> 35.0 kg/m2

          3. Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening

          4. Asthma or other chronic lung disease that is greater than mild in severity.
             Specifically excluded are participants with 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

          5. History of diabetes mellitus (gestational diabetes is allowed if treatment was not
             required postpartum and serum glucose is currently in the normal range)

          6. History of coronary artery disease, arrhythmia, or congestive heart failure

          7. Clinically significant ECG abnormality

          8. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood
             pressure > 95 mmHg) at Screening or pre-dose on Day I

          9. History of anaphylaxis or angioedema

         10. Known allergy to any of the ingredients in the vaccine formulation including egg
             allergy

         11. History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other
             nasal abnormality that might affect vaccine administration

         12. Previous nasal surgery or nasal cauterization

         13. Any symptoms of upper respiratory infection or temperature> 38°C within 3 days before
             Day I

         14. Significant nasal congestion or rhinorrhea as assessed by the investigator.

         15. 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

         16. 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

         17. Use of statin medication within 30 days before Day I (including atorvastatin,
             fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin)

         18. Receipt of intranasal medications (including over-the-counter medications) within 30
             days before Day 1

         19. Receipt of any IP within 30 days before Day 1

         20. Receipt of any vaccine within 30 days before Day I

         21. Receipt of intranasal vaccine within 90 days before Day I

         22. Receipt of any influenza vaccine within 6 months before Day I

         23. Any change in medication for a chronic medical condition within 30 days before Day I

         24. Past regular use or current use of intranasal illicit drugs or any regular use of
             illicit drugs by any other route.

         25. Use of tobacco products or electronic cigarettes within 30 days before Day l. Any
             other smoking products including marijuana will be excluded.

         26. Any medical, psychiatric, or social condition or any 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
             immunogenicity), or a subject's ability to give informed consent