A Phase 1/2, Randomized, Open-Label, Study to Assess the Immunogenicity and Safety of a Vaccine Enhancement Patch (VEP) When Administered With Two Doses of Intramuscular Inactivated Influenza H5N1 Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 5
- 主要终点
- Evaluate hemagglutination inhibition (HI) immune responses
研究概览
简要总结
Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site.
The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy adult males or females 18-49 years of age (inclusive)
- •signed Informed Consent
- •Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and at all in-clinic visits with understanding to not become pregnant over the duration of the study.
排除标准
- •Clinically significant laboratory abnormalities at screening
- •abnormalities at physical examination
- •known allergies to any component of the A/H5N1 antigen
- •known egg protein allergy
- •known allergies to adhesives
- •known coagulation disorders
- •use of any anticoagulant medication within 30 days prior to vaccination or planned usage during the study period
- •participated in research involving investigational product within 30 days before planned date of vaccination or planned participation during study period
- •donated or received blood or blood products such as plasma within the three months before planned date of vaccination or planned donation or use during the study period
- •received or planned receipt of seasonal influenza vaccine during the study period
- •received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live vaccines) prior to planned date of vaccination
- •planned receipt of any licensed vaccine during the first 42 days on study
- •previous or planned vaccination with any vaccine containing an oil in water emulsion adjuvant
- •previous or planned vaccination with pandemic vaccine against A/H5N1 or previous proven contact with A/H5N1 wild type virus
- •ever received investigational enterotoxigenic E. coli LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd. Ever received cholera toxin or vaccine
- •Recent or regular use of oral, topical or injected steroid medications within 30 days prior to vaccination or planned use during the study period.
- •Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination or planned use during the study period
- •Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, and end-stage renal disease, as determined by the Investigator
- •positive serology for HIV-1, HIV-2, HBsAg, or HCV
- •history of severe atopy
- •medical history of acute or chronic skin disease at vaccination area
- •active skin allergy
- •signs of acute skin infection, sunburn or skin abnormalities at the vaccination area including fungal infections, severe acne, active contact dermatitis, or a history of keloid formation
- •hirsute at vaccination area
- •artificial tanning over the duration of the study including the screening period
- •visible tattoos or marks at the vaccination area that would prevent appropriate dermatologic monitoring of the vaccination site
- •fever greater than or equal to 38.0°C at the time of planned vaccination
- •suspicion of or recent history of alcohol or substance abuse
- •women who are pregnant or breastfeeding
- •acute illness at screening or at the time of planned vaccination
- •ever had a serious reaction to prior influenza vaccination
- •developed a neurological disorder following a previous influenza vaccination or have any acute and evolving neurological disorder
- •employee of the investigational site or sponsor
- •history of employment in bird or poultry industries or considerable exposure to birds
研究组 & 干预措施
Group 1
3.8 mcg with AS03 adjuvant at D0 and 21
干预措施: A/H5N1 Antigen (Biological)
Group 2
15 mcg at D0 and 21
干预措施: A/H5N1 Antigen (Biological)
Group 3
15 mcg + 50 mcg VEP at D0 and 21
干预措施: A/H5N1 Antigen (Biological)
Group 3
15 mcg + 50 mcg VEP at D0 and 21
干预措施: Vaccine Enhancement Patch (Drug)
Group 4
30 mcg + 50 mcg VEP at D0
干预措施: A/H5N1 Antigen (Biological)
Group 4
30 mcg + 50 mcg VEP at D0
干预措施: Vaccine Enhancement Patch (Drug)
结局指标
主要结局
Evaluate hemagglutination inhibition (HI) immune responses
时间窗: Day 42
Evaluate hemagglutination inhibition (HI) immune responses to two doses of 15μg A/H5N1 achieved in the antigen plus VEP group versus the antigen alone group (Group 3 vs. Group 2) at Day 42 using standard serological parameters (Geometric Mean Titer \[GMT\], Geometric Mean Fold Ratio \[GMFR\], seroconversion and seroprotection).
次要结局
- Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP(8 months)
- Characterize HI immune responses(8 months)