NCT01719783已完成1 期
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Turkey/Turkey/05/133 (H5N2) Influenza Vaccine
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse Events by Severity
研究概览
简要总结
To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Legal male or female adult 18 through 49 years of age at the enrollment visit.
- •Literate and willing to provide written informed consent.
- •Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
- •Capable and willing to complete diary cards and willing to return for all follow-up visits
- •Willing to comply with the rules of the isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by a study physician).
- •For females, willing to take reliable birth control measures throughout the entire period of participation in the study.
排除标准
- •Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
- •Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
- •Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
- •Recent history of frequent nose bleeds (>5 within the past year).
- •Clinically relevant abnormal paranasal anatomy.
- •Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
- •Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
- •Other acute illness at the time of study enrollment.
- •Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
- •Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed, exclusive of nasal.)
- •Participation in any previous trial of any H5 or H7 containing influenza vaccine.
- •History of asthma.
- •Hypersensitivity after previous administration of any influenza vaccine.
- •History of wheezing after past receipt of any live influenza vaccine.
- •Other adverse event (AE) following immunization, at least possibly related to previous receipt of any influenza vaccine.
- •Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
- •Seasonal (autumnal) hypersensitivity to the natural environment.
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. Subjects with physical examination findings or clinical laboratory screening results which would be graded 2 or higher on the AE severity grading scale (see Attachments) will be excluded from entry into the study and will be excluded from receipt of dose two of study vaccine or placebo.
- •History of leukemia or any other blood or solid organ cancer.
- •History of thrombocytopenic purpura or known bleeding disorder.
- •History of seizures.
- •Known or suspected immunosuppressive or immunodeficient condition of any kind, including HIV infection.
- •Known chronic hepatitis B (HBV) or hepatitis C (HCV) infection.
- •Known tuberculosis infection or evidence of previous tuberculosis exposure.
- •History of chronic alcohol abuse and/or illegal drug use.
- •Claustrophobia or sociophobia.
- •Pregnancy or lactation. (A negative pregnancy test will be required before administration of study vaccine or placebo for all women of childbearing potential.)
- •Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives
研究组 & 干预措施
LAIV H5N2
Experimental
Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
干预措施: LAIV H5N2 (Biological)
Placebo
Placebo Comparator
two doses of placebo solution intranasal
干预措施: Placebo (Other)
结局指标
主要结局
Adverse Events by Severity
时间窗: 6 days
Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity
次要结局
- Number/Percentage of Subjects With Serum Neutralizing Antibodies(28 days (Dose 1) and 56 days (Dose 2))
- Number/Percentage of Subjects With Seroconversion for Secretory IgA(28 days (Dose 1) and 56 days (Dose 2))
- Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)(28 days (Dose 1) and 56 days (Dose 2))
- Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose(6 days post-vaccination)
- Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)(28 days (Dose 1) and 56 days (Dose 2))
- Number/Percentage of Subjects With Seroconversion for IgA in Saliva(28 days (Dose 1) and 56 days (Dose 2))
- Geometric Mean Titers for Serum HAI Antibodies(0 days, 28 days (Dose 1) and 56 days (Dose 2))
- Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)(28 days (Dose 1) and 56 days (Dose 2))
- Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose(6 days post-vaccination)
- Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies(0 days, 28 days (Dose 1) and 56 days (Dose 2))
研究者
研究点 (1)
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