Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

Completed · Phase 1 · Has a placebo group

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT02438423

Run by

Mark Prausnitz

People needed

100

Starts

2015-06-01

Expected to finish

2016-03-23

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

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
• Subject has a history of Guillain-Barre Syndrome.
• Subject is pregnant, post-partum (<12 months after delivery), or breast feeding or plans to breastfeed during the study.
• 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.
• 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.
• Subject has received any experimental products within 30 days before study entry or plan to receive experimental products at any time during the study.
• 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.
• 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.
• Subject has received immunoglobulin or blood products in the past 90 days or planned receipt at any time during the study.
• Subject BMI >35 kg/m2.
• Subject has a systolic blood pressure >160 or < 80 mmHg or diastolic blood pressure >100 or < 60 mmHg.

Where it is running

• The Hope Clinic — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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