A Phase I Study of the Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
研究概览
简要总结
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.
详细描述
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.
Population: healthy adults, 18-49 years inclusive
Number of Sites: One
Study Duration: 12 months
Subject Duration: 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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/m
- •Subject has a systolic blood pressure >160 or < 80 mmHg or diastolic blood pressure >100 or < 60 mmHg.
- •Subject has a resting pulse rate < 50 bpm or >100 bpm.
- •Subject donated blood 56 days before screening OR will donate blood on or before day 28 of the study.
研究组 & 干预措施
IIV delivered by MN patch by study staff
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
干预措施: Inactivated influenza vaccine (Biological)
IIV delivered IM by study staff
Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
干预措施: Inactivated influenza vaccine (Biological)
IIV delivered by MN patch by subject
Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
干预措施: Inactivated influenza vaccine (Biological)
Placebo MN patch by study staff
Placebo delivered by microneedle patch administered by study staff
干预措施: Placebo (Other)
结局指标
主要结局
Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
时间窗: 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.
Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.
时间窗: From Day 0 until Day 28
Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.
时间窗: From Day 0 until Day 180
次要结局
- 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 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)
- 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)
研究者
Mark Prausnitz
Investigator
Georgia Institute of Technology