Phase 1
Completed N=100
Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle
Source: ClinicalTrials.gov NCT02438423 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Jul 2019
Primary outcomePrimary: Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration. — 20; 4; 21; 4 Reactions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration. |
20; 4; 21; 4; 5; 11 | — |
| PRIMARY Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration. |
0; 0; 0; 0 | — |
| PRIMARY Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration. |
0; 0; 0; 0 | — |
| SECONDARY 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). |
1197; 997.3; 287; 223.2; 125.8; 94.48 | — |
| SECONDARY 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). |
100; 100; 100; 100; 96; 100 | — |
| SECONDARY 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). |
92; 80; 83; 76; 71; 32 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 ( 35 kg/m2.
- Subject has a systolic blood pressure >160 or 100 or 100 bpm.
- Subject donated blood 56 days before screening OR will donate blood on or before day 28 of the study.
Data sourced from ClinicalTrials.gov (NCT02438423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.