A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2.
研究概览
简要总结
Japanese encephalitis (JE) live attenuated vaccine SA14-14-2 has been in use for more more than 20 years in Asia. JE vaccine SA14-14-2 is licensed in India and has been widely used since 2006. JE vaccines give protection by generating a neutralizing antibody response, but both naturally exposed persons and patients with JE also have T cell responses. Whether JE vaccine SA14-14-2 elicits T cell responses is unknown. This study tests the hypothesis that T cell responses are generated in response to JE SA14-14-2 vaccination. The aim of this study is to characterize T cell responses to JE vaccine SA14-14-2 in healthy people, and to investigate differences in T cell responses between natural exposure, vaccination and disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding administration of SA14-14-2 vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within a period of six months before vaccination or at any time during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •A family history of congenital or hereditary immunodeficiency.
- •Any antiviral drug therapy within a period of six months before vaccination or at any time during the study period.
- •History of significant allergic disease or reactions likely to be exacerbated by any component of the study vaccine, especially allergic disease or reactions to any previous dose of any vaccine.
- •History of having received JE vaccine, yellow fever vaccine, tick-borne encephalitis vaccine or experimental flavivirus vaccine.
- •History of documented JE infection.
- •Detectable anti JE or West Nile neutralizing antibodies in screening tests.
- •Acute disease at the time of enrollment. Entry into the study may be deferred until the illness is resolved.
- •Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, neurological or renal functional abnormality, as determined by history and physical or laboratory examination that is not controlled by drugs.
- •Administration of immunoglobulins and/or any blood products within the three months preceding administration of vaccine, or planned administration during the study period.
- •Seropositive for HIV, HCV or HbsAg.
- •Lactation, pregnancy or intention to get pregnant.
- •History of excessive alcohol consumption, drug abuse or significant psychiatric illness.
- •Any other condition that in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
研究组 & 干预措施
Vaccine
Single dose live attenuated Japanese encephalitis vaccine SA14-14-2
干预措施: Live attenuated Japanese encephalitis vaccine SA14-14-2 (Biological)
结局指标
主要结局
Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2.
时间窗: Week 1, week 2, week 4, week 8, 6 months
Interferon gamma (IFNγ) spot forming cells (SFC)/million peripheral blood mononuclear cells (PBMC) at week 2 (peak response)
次要结局
- Number of Participants Reporting Adverse Events (Graded in Severity 1-4).(one month)
- Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination.(4 weeks)
研究者
Prof S Vijaya, Dr. Lance Turtle
Professor
Indian Institute of Science