Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated influenza vaccine; Placebo
Intervention description: Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of
      Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.

      This is a single center, partially blinded, randomized phase I study in which healthy adult
      subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by
      microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is
      designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an
      inactivated influenza vaccine delivered by microneedle patch.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject provides written informed consent prior to any study procedures being
             performed.

          2. Subject is male or non-pregnant female between the ages of 18 and 49, inclusive, on
             the day of signing informed consent.

          3. Subject is in good health as determined by vital signs, medical history and targeted
             physical examination

          4. Women of childbearing potential must agree to practice abstinence from sexual
             intercourse with men or use acceptable contraception, initiated at least 30 days prior
             to the study vaccination throughout D180 in order to avoid pregnancy.

          5. Women of childbearing potential must have a negative urine pregnancy test prior to
             administration of the study product.

          6. Subject is able to understand and comply with required study procedures.

        Exclusion Criteria:

          1. Subject has received a 2014-2015 seasonal influenza vaccine.

          2. Subject with documented influenza infection during the 2014-2015 influenza season.

          3. Subject has touched or handled a microneedle patch prior to study enrollment
             (excluding dermaroller-like devices).

          4. Subject has a known allergy to eggs, egg or chicken protein or other components of the
             study product

          5. Subject has a history of severe reactions following previous immunization with
             licensed influenza virus vaccines.

          6. Subject has an acute illness with fever (temperature >100.4 °F) within 72 hours prior
             to vaccination.

          7. Subject has a known chronic medical problem

          8. Subject has known immunosuppression due to underlying illness or treatment

          9. Subject has a scar, tattoo, rash or other dermatologic condition in the area of the
             vaccination site which will interfere with the assessment of injection site
             reactogenicity.

         10. Subject has a history of keloid formation.

         11. Subject has used long-term* high-dose** oral or parenteral glucocorticoids, or
             high-dose inhaled steroids***.

               -  Long term is defined as taken for 2 weeks or more in total at any time during the
                  past 2 months.

               -  High dose defined as prednisone ≥ 20 mg total daily dose, or equivalent dose of
                  other glucocorticoids.

               -  High dose defined as > 800 mcg/day of beclomethasone dipropionate or equivalent.

             If short term corticosteroids are given, then the subject should not receive study
             vaccination or have blood collected for immunogenicity studies within 1 week of
             steroid administration

         12. Subject has a history of Guillain-Barre Syndrome.

         13. Subject is pregnant, post-partum (<12 months after delivery), or breast feeding or
             plans to breastfeed during the study.

         14. Alcohol or drug abuse and psychiatric conditions that, in the opinion of the
             investigator, would preclude compliance with the trial or interpretation of safety or
             endpoint data.

         15. Subject has any condition that, in the opinion of the investigator, may put the
             subject at increased risk of harm, may cause the subject to be unable to meet the
             requirements or might otherwise interfere with evaluations required by the study.

         16. Subject has received any experimental products within 30 days before study entry or
             plan to receive experimental products at any time during the study.

         17. Subject has received a live vaccine within 28 days prior to study entry or plans to
             receive a live vaccine prior to Day 28 of the study.

         18. Subject has received an inactivated vaccine within 14 days prior to study entry or
             plans to receive an inactivated vaccine prior to Day 28 of the study.

         19. Subject has received immunoglobulin or blood products in the past 90 days or planned
             receipt at any time during the study.

         20. Subject BMI >35 kg/m2.

         21. Subject has a systolic blood pressure >160 or < 80 mmHg or diastolic blood pressure
             >100 or < 60 mmHg.

         22. Subject has a resting pulse rate < 50 bpm or >100 bpm.

         23. Subject donated blood 56 days before screening OR will donate blood on or before day
             28 of the study.