Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

NCT02438423 | Completed Phase 1 Results DMC

• 1 other identifier: 2015 TIV-MNP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.

  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.

  From Day 0 through Day 8

• Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.

  From Day 0 until Day 180

• Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.

  From Day 0 until Day 28

Secondary Outcomes (3)

• 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).

  At Day 28

• 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).

  At Day 28

• 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).

  At Day 28

Study Arms (4)

IIV delivered by MN patch by study staff

EXPERIMENTAL

Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff

Biological: Inactivated influenza vaccine

IIV delivered IM by study staff

ACTIVE COMPARATOR

Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff

Biological: Inactivated influenza vaccine

IIV delivered by MN patch by subject

EXPERIMENTAL

Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject

Biological: Inactivated influenza vaccine

Placebo MN patch by study staff

PLACEBO COMPARATOR

Placebo delivered by microneedle patch administered by study staff

Other: Placebo

Interventions

Inactivated influenza vaccine BIOLOGICAL

Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season

IIV delivered IM by study staff; IIV delivered by MN patch by study staff; IIV delivered by MN patch by subject

Placebo OTHER

Placebo MN patch by study staff

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject provides written informed consent prior to any study procedures being performed.
• Subject is male or non-pregnant female between the ages of 18 and 49, inclusive, on the day of signing informed consent.
• Subject is in good health as determined by vital signs, medical history and targeted physical examination
• 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.
• Women of childbearing potential must have a negative urine pregnancy test prior to administration of the study product.
• Subject is able to understand and comply with required study procedures.

You may not qualify if:

• Subject has received a 2014-2015 seasonal influenza vaccine.
• Subject with documented influenza infection during the 2014-2015 influenza season.
• Subject has touched or handled a microneedle patch prior to study enrollment (excluding dermaroller-like devices).
• Subject has a known allergy to eggs, egg or chicken protein or other components of the study product
• Subject has a history of severe reactions following previous immunization with licensed influenza virus vaccines.
• Subject has an acute illness with fever (temperature \>100.4 °F) within 72 hours prior to vaccination.
• Subject has a known chronic medical problem
• Subject has known immunosuppression due to underlying illness or treatment
• 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.
• Subject has a history of keloid formation.
• 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

Sponsors & Collaborators

• Mark Prausnitz: lead
• Emory University: collaborator

Study Sites (1)

The Hope Clinic

Decatur, Georgia, 30030, United States

Location

Related Publications (1)

• Rouphael NG, Paine M, Mosley R, Henry S, McAllister DV, Kalluri H, Pewin W, Frew PM, Yu T, Thornburg NJ, Kabbani S, Lai L, Vassilieva EV, Skountzou I, Compans RW, Mulligan MJ, Prausnitz MR; TIV-MNP 2015 Study Group. The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial. Lancet. 2017 Aug 12;390(10095):649-658. doi: 10.1016/S0140-6736(17)30575-5. Epub 2017 Jun 27.

  PMID: 28666680 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mark Prausnitz, PhD
• Organization: Georgia Tech

prausnitz@gatech.edu

404-894-5135

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: June 1, 2015
• Primary Completion: March 23, 2016
• Study Completion: March 23, 2016
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

US (1)