NCT00189904已完成1 期
A Multicenter, Open-label Phase I/II Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in HIV Infected Subjects (CD4 Counts >350 / µl) and Healthy Subjects With and Without Previous Smallpox Vaccination
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 10
- 主要终点
- Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study
研究概览
简要总结
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects between 18 and 49 years of age or female subjects between 18 and 55 years of age who provided informed consent.
- •Women with negative pregnancy test.
- •Women of childbearing potential must use an acceptable method of contraception.
- •Cardiac enzymes within ULN.
- •White blood cells ≥ 2500/mm3 and < 11,000/ mm
- •Absolute neutrophil count ≥ 1000/mm
- •Adequate renal function.
- •Adequate hepatic function.
- •Negative hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
- •Negative antibody test to hepatitis C virus (HCV).
- •Negative urine glucose by dipstick or urinalysis.
- •Normal 12-lead electrocardiogram.
- •Availability for follow-up during the study.
- •Groups 1 and 3 (All vaccinia-naïve subjects) additionally:
- •No history of known or suspected previous smallpox vaccination.
- •No detectable vaccinia scar.
- •No military service prior to 1989 or after January
- •Groups 2 and 4 (All previously vaccinated subjects) additionally:
- •History of at least one previous smallpox vaccination
- •Time since most current smallpox vaccination > 10 years.
- •Groups 1 and 2 (All HIV Infected subjects) additionally:
- •Documented HIV-1 infection
- •Plasma HIV-1 RNA level < 400 copies/mL at screening.
- •CD4 cells ≥ 350/µL
- •Haemoglobin ≥ 9.0 g/dL.
- •Platelets ≥ 100,000/mm
- •AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN
- •Groups 3 and 4 (All Healthy subjects) additionally:
- •Negative ELISA for HIV.
- •Haemoglobin >11 g/dL.
- •Platelets ≥ 140,000/mm
- •AST (SGOT), ALT (SGPT) and alkaline phosphatase without clinically significant findings
排除标准
- •Pregnant or breast-feeding women.
- •Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- •History of any serious medical condition (other than HIV infection).
- •History of or active autoimmune disease.
- •Known or suspected impairment of immunologic function (other than HIV infection).
- •History of malignancy.
- •History or clinical manifestation of clinically significant and severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- •Clinically significant mental disorder not adequately controlled by medical treatment.
- •Any condition which might interfere with study objectives.
- •History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
- •History of an immediate family member with onset of ischemic heart disease before age
- •Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool.
- •History of chronic alcohol abuse and/or intravenous drug abuse.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Known previous allergic reaction to immunoglobulins.
- •Known allergies to cidofovir or probenecid.
- •History of anaphylaxis or severe allergic reaction.
- •Acute disease (illness with or without a fever) at the time of enrollment.
- •Temperature >100.4°F at the time of enrollment.
- •Subjects undergoing treatment for tuberculosis infection or disease.
- •Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
- •Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after study vaccination.
- •Chronic administration of immuno-suppressant or immune-modifying drugs.
- •Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- •Administration or planned administration of immunoglobulins and/or any blood products.
- •Use of any investigational or non-registered drug or vaccine.
结局指标
主要结局
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study
次要结局
- Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points)
- ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points)
研究者
研究点 (10)
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