NCT00902824已完成1 期
Phase I Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TBC-M4 (MVA Based HIV Vaccine) Alone or in a Prime-Boost Regimen With ADVAX, DNA HIV Vaccine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX
研究概览
简要总结
This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses.
详细描述
Two vaccine candidates will be used in two different prime-boost regimens: ADVAX (DNA) + TBC-M4 (MVA) and TBC-M4 (MVA) alone. Both these vaccines have already been tested in humans and both were found to be well tolerated and immunogenic. Approximately 32 volunteers (24 vaccine /8 placebo recipients) will be included in the study.
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 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
- •Confirmed HIV-1 or HIV-2 infection;
- •High-risk behaviour for HIV infection which is defined as (Within 6 months before vaccination, the volunteer has):
- •Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e., no continuing established relationship)
- •Engaged in sex work for money or drugs
- •Substance abuse/use injection drugs
- •Acquired a sexually transmitted disease (STD) (e.g., gonorrhoea, chlamydia, syphilis, Trichomonas vaginalis, and symptomatic herpes genitalis)
- •Having a high-risk partner either currently or within the previous 6 months
- •Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator within the previous 6 months; (Note: use of inhaled steroids for asthma and use of topical steroids for localized skin conditions will not exclude a volunteer from participation.)
- •Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study;
- •Any of the following abnormal laboratory parameters listed below:
- •Haemoglobin <10.0 g/dL
- •Absolute Neutrophil Count (ANL): <1,000/mm3
- •Absolute Lymphocyte Count (ALC): <600/mm3
- •Platelets: <100,000/mm3
- •Creatinine: >1.3 x ULN
- •AST: >2.5 x ULN
- •ALT: >2.5 x ULN
- •Cardiac Troponin I: > ULN
- •Urinalysis: Abnormal dipstick confirmed by microscopy:
- •blood = 3+ or more (not due to menses)
- •protein = 3+ or more
- •leucocytes = 3+ or more
- •Confirmed diagnosis of hepatitis B (HBsAg), hepatitis C (HCV antibodies), or active syphilis;
- •If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating;
- •Receipt of live attenuated vaccine within the previous 60 days (live attenuated flu vaccine within 14 days) or planned receipt within 60 days after vaccination with Investigational Product or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product;
- •Receipt of blood transfusion or blood products within the previous 6 months.
- •Participation in another clinical study of an investigational product currently, within the previous 3 months or expected participation during this study;
- •Receipt of another investigational HIV vaccine in the last 6 years (note: receipt of an HIV vaccine placebo will not exclude a subject from participation if documentation is available to the study site and the IAVI Medical Monitor gives approval);
- •History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions;
- •Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years;
- •Smallpox vaccination within the previous 3 years;
- •ECG with clinically significant findings or features that would interfere with the assessment of myopericarditis, including but not limited to:
- •Conduction disturbance (atrio-ventricular or intra-ventricular conduction, left or right bundle branch block, AV block of any degree, or QTc prolongation)
- •Repolarization (ST segment or T wave) abnormality
- •Significant atrial or ventricular arrhythmia
- •Frequent atrial or ventricular arrhythmia
- •Frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, two premature ventricular contractions in a row)
- •ST elevation consistent with ischemia
- •Evidence of past or evolving myocardial infarction (heart attack).
- •History of, or known active cardiac disease, including but not limited to:
- •Previous myocardial infarction
- •Angina pectoris
- •Congestive heart failure
- •Valvular heart disease, including mitral valve prolapse
- •Cardiomyopathy
- •Pericarditis
- •Stroke or transient ischemic attack
- •Chest pain or shortness of breath with activity (such as walking up stairs)
- •Other heart conditions under the care of a doctor.
- •Have 3 or more of the following risk factors:
- 另有 5 项未显示
结局指标
主要结局
Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX
时间窗: 12 months
Safety and tolerability of TBC-M4 alone (given im) or in a prime-boost regimen with ADVAX (administered by Biojector)
次要结局
- Immunogenicity of TBM-M4 alone or in a prime-boost regimen with ADVAX(12 months)
研究者
研究点 (2)
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