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Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438423
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Mark Prausnitz, Georgia Institute of Technology

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Influenza Biological: Inactivated influenza vaccine Other: Placebo Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Phase I Study of the Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle
Study Start Date : June 2015
Actual Primary Completion Date : March 23, 2016
Actual Study Completion Date : March 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: IIV delivered by MN patch by study staff
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
 Biological: Inactivated influenza vaccine
Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
Active Comparator: IIV delivered IM by study staff
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
 Biological: Inactivated influenza vaccine
Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
Experimental: IIV delivered by MN patch by subject
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
 Biological: Inactivated influenza vaccine
Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
Placebo Comparator: Placebo MN patch by study staff
Placebo delivered by microneedle patch administered by study staff
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration. [ Time Frame: From Day 0 through Day 8 ]
    Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after, and serious adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study product administration. Local and systemic reactions were graded using an Injection Site Reaction table listing local reactions (e.g., swelling, erythema, etc.) and grade levels from 0 to 4 for each local reaction, a General Adverse Reaction table listing systemic reactions (e.g., fatigue, myalgia, etc.) and grade levels from 0 to 4 for each systemic reaction, and a Clinical Adverse Event Grading Scale (grades 1-4) for safety labs. In all tables, the higher the grade, the worse the adverse event.

  2. Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration. [ Time Frame: From Day 0 until Day 180 ]
  3. Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration. [ Time Frame: From Day 0 until Day 28 ]

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of HAI Antibody Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff). [ Time Frame: At Day 28 ]
  2. Percentage of Subjects Achieving Seroprotection (Defined as a HAI Antibody Titer of 1:40 or Greater) Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff). [ Time Frame: At Day 28 ]
  3. Percentage of Subjects Achieving Seroconversion Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff). [ Time Frame: At Day 28 ]
    Seroconversion is defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438423


Locations
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United States, Georgia
The Hope Clinic
Decatur, Georgia, United States, 30030
Sponsors and Collaborators
Mark Prausnitz
Emory University
Investigators
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Principal Investigator: Nadine Rouphael, MD Emory University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mark Prausnitz, Investigator, Georgia Institute of Technology
ClinicalTrials.gov Identifier: NCT02438423    
Other Study ID Numbers: 2015 TIV-MNP
First Posted: May 8, 2015    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases