A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
研究概览
简要总结
The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.
The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
详细描述
Objectives:
The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females in good general health, 19-49 years of age
- •Subjects must provide written consent
- •Willing to participate through study completion
- •Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
- •Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
- •Meet screening criteria for hematology, chemistry and urinalysis
排除标准
- •Pregnant (or possibly pregnant) and lactating women
- •Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
- •Any intranasal steroid medication administered in the 10 days prior to study enrollment
- •History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
- •Any previous nasal cautery or significant surgery for nasal septal defects
- •Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use
- •Asthma that is greater than mild in severity
- •Diagnosed active Hepatitis B or C
- •HIV positive at screening
- •Known or suspected malignancy, leukemia, or lymphoma
- •Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids
- •Receipt of an influenza vaccine within the past 6 months
- •Receipt of any vaccine in the past 30 days
- •Receipt of any investigational drug in the past 30 days
- •Known Diabetes mellitus
- •History of anaphylaxis or angioedema
- •Hypertension that is not well controlled
- •Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent
研究组 & 干预措施
Group 1
There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
干预措施: Pandemic Influenza Vaccine (Biological)
Group 2
There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
干预措施: Pandemic Influenza Vaccine (Biological)
Group 3
There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).
干预措施: Pandemic Influenza Vaccine (Biological)
Experimental: Group 4
There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d).
干预措施: Placebo (Biological)
结局指标
主要结局
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
时间窗: 56 day observations with 2 year follow-up
次要结局
- Determination of immunogenicity and correlates of protection based on HI titers in vaccinates(28 days and 56 days post vaccination)