NCT01250795已完成1 期
A Phase 1a/b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Reactogenicity, and Immunogenicity of FhCMB HAI-05, a Recombinant Hemagglutinin (rHA) Vaccine Derived From Influenza A/Indonesia/05/2005 (H5N1), in Healthy Adults 18 to 49 Years
Fraunhofer, Center for Molecular Biotechnology4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年11月1日最近更新:
适应症
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
- 4
- 主要终点
- safety
研究概览
简要总结
The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults.
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
- Double (Participant, 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
- •Subjects accepted for this study must meet the following inclusion criteria:
- •Male or female aged 18 to 49 years inclusive
- •Able to give written informed consent to participate
- •Healthy as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
- •Females should fulfill one of the following criteria:
- •At least 1 year post-menopausal
- •Surgically sterile
- •Will use oral, implantable, transdermal, or injectable contraceptives for 30 days prior to first vaccination and until 28 days after each vaccination
- •Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the investigator (e.g., intrauterine device [IUD], female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner, or a sterile sexual partner) for study duration and until 28 days after vaccination
- •Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
- •Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period
排除标准
- •Any of the following are cause for exclusion from the study:
- •Prior receipt of any influenza vaccine containing H5
- •Presence of significant uncontrolled medical or psychiatric illness (acute or chronic); includes institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day 1 prior to vaccination
- •Positive serology for human immunodeficiency virus (HIV 1 or HIV 2), hepatitis B surface antigen (HBsAg). or hepatitis C (HCV)
- •Cancer or treatment for cancer within 3 years excluding basal cell carcinoma or squamous cell carcinoma which are allowed
- •Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus
- •Presently receiving (or has a history of receiving) during the preceding 3 month period any medications or other treatments that may adversely affect the immune system, such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs; other drugs known to be frequently associated with significant major organ toxicity; or systemic (oral or injectable) corticosteroids (inhaled and topical corticosteroids allowed)
- •Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination and during the study (Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use vaccine-tetanus and diphtheria [Td] or tetanus, diphtheria, and pertussis [Tdap] up to 8 days before or at least 8 days after a dose of study vaccine will be allowed, and administration of study vaccine injection can be delayed if a nonstudy vaccine has been administered and will be given as soon as acceptable [as described above] provided the vaccine is not administered within 2 weeks prior to study enrollment.)
- •History of significant allergic reactions (anaphylactic-type reactions, respiratory difficulties, or angioedema) to injected vaccines or to any of the study vaccine components
- •History of drug or chemical abuse in the year before the study; positive urine drug screen at screening.
- •Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period
- •Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period
- •Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study
- •Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination) with or without fever, or a fever >38ºC orally (Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade fever, and vaccination can be delayed until the subject has recovered.)
- •Any condition that, in the opinion of the investigator, might interfere with the primary study objectives or the subject's safety
结局指标
主要结局
safety
时间窗: 200 days
次要结局
- immunogenicity(day 43)
研究者
研究点 (4)
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