NCT00189930已完成2 期
A Single-blind, Randomized, Controlled, Phase II Study to Evaluate Immunogenicity and Safety of Two Doses of the MVA-nef HIV Vaccine in HIV-1 Infected Patients With CD4 > 250/µl
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 5
- 主要终点
- T-cell response against MVA-BN and the Nef antigen assessed by intracellular cytokine staining assay (ICS)
研究概览
简要总结
The objective of the study is to compare two doses of MVA-nef vs. MVA-BN to induce Nef-specific cellular immune response in HIV-1 infected patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-60
- •HIV-1 infection, as documented by any licensed PCR kit or ELISA (confirmed by an complementary assay e.g. Western blot HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA) at any time prior to study entry.
- •Stable on HAART for at least 6 consecutive months prior to study entry (changes of one drug for the another drug due to reasons other than virologic failure are allowed)
- •Plasma HIV-1 RNA levels of < 50 copies/ml for at least 6 months prior to study entry (two single blips of up to 200 HIV-1 RNA copies/ml are acceptable if they resolve spontaneously without a change in HAART)
- •Plasma HIV-1 RNA levels of < 50 copies/ml at study entry
- •CD4 nadir >100
- •CD4+ cell counts > 250/µl (one measurement within 4 months prior to study entry and one measurement within screening phase)
- •For women, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination.
- •If the volunteer is female and of childbearing potential, she agrees to use an acceptable method of contraception, and not become pregnant for at least 56 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) with use of method for a minimum of 30 days prior to vaccination).
- •ALT/SGPT, AST/SGOT, and alkaline phosphatase < 3 times institutional upper limit of normal (ULN).
- •Urine protein by dipstick or urinalysis < 100mg/dl or <2+ proteinuria
- •CBC: Haemoglobin >8 g/dl; White blood cells greater than 2,500 and less than 11,000/mm3; Platelets greater than or equal to 100,000/mm3
- •Read, signed and dated informed consent document after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure
- •Cardiac enzymes: within normal range.
排除标准
- •Pregnant or breast-feeding women.
- •Administration of any HIV nef vaccine or vaccinia immunization within the past 5 years.
- •Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- •History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
- •History of or active autoimmune disease. Persons with vitiligo or thyroid disease on thyroid replacement are not excluded.
- •History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
- •History or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- •Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator.
- •ECG with clinical significance (complete left or right bundle branch block, or sustained ventricular arrythmia, or 2 PVCs in a row, or ST elevation consistent with ischemia).
- •History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
- •3 or more of the following risk factors:
- •High blood pressure requiring therapy.
- •High blood cholesterol (> 300 mg/dl or ratio LDL/HDL ≥ 3) not induced by the HIV therapy.
- •Diabetes mellitus or high blood sugar.
- •He/she has a first degree relative (for example mother, father, brother, or sister) who had a heart condition before the age of
- •Smoking cigarettes now.
- •History of chronic alcohol abuse (40g / day for at least 6 month) and/or intravenous drug abuse (within the past 6 month).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of anaphylaxis or severe allergic reaction.
- •Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
- •Any vaccinations with active vaccines within a period starting 30 days prior to administration of the vaccine and ending 30 days after administration of the study vaccine. Any vaccinations with inactive vaccines within a period starting 14 days prior to administration of the vaccine and ending 14 days after administration of the study vaccine.
- •Chronic administration (defined as more than 14 days) of immuno- suppressant or immune-modifying drugs during the study period (Corticosteroid nasal sprays are permissible. Subjects who have used topical and inhaled steroids can be enrolled after their therapy is completed).
- •Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is longer) preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
研究组 & 干预措施
1
Active Comparator
High dose
干预措施: MVA-nef (Biological)
2
Active Comparator
Low dose
干预措施: MVA-nef (Biological)
3
Placebo Comparator
干预措施: IMVAMUNE (Biological)
结局指标
主要结局
T-cell response against MVA-BN and the Nef antigen assessed by intracellular cytokine staining assay (ICS)
时间窗: 52 Weeks
次要结局
- Occurrence, intensity and relationship of adverse events occurring at any time during the study(52 weeks)
研究者
研究点 (5)
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