NCT00376090已完成1 期
A Phase I Double-Blind, Randomized, Dose Escalating, Placebo-Controlled, Study of Safety and Immunogenicity of WRAIR/NIH Live Recombinant MVA-CMDR (HIV-1 CM235 Env/ CM240 Gag/Pol) Administered by Intramuscular (IM) or Intradermal (ID) Route In HIV-Uninfected Adults
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2005年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this study is to determine the safety and the immune responses to the HIV vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three HIV "passenger" genes encoded with the viral vector, MVA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A participant must meet all of the following criteria:
- •Low risk for HIV infection
- •18 to 40 years at the time of enrollment and vaccinia naive
- •Good health
- •Availability for 12 months of participation.
- •Successful completion of the Test of Understanding
- •Able and willing to give informed consent.
- •HEMATOCRIT: WOMEN: 35 %-45 %; MEN 36 % - 49 %
- •White cell count: 3,000 - 11,000 cells/mm3
- •Platelets: 125,000 - 450,000 per mm3
- •Normal cardiac enzyme level at second Screening Visit
- •Urinalysis (UA) for protein and blood: negative or trace.
- •Normal liver function tests to include ALT/AST, alkaline phosphatase, GGT (< 1.25x institutional upper limits of normal) and CPK (< 480) and creatinine (< 1.25 mg/dL)
- •Negative serology for HIV infection
- •Any female volunteer must have a negative serum or urine pregnancy test at the screening visit as well as immediately prior to each vaccine/placebo vaccination, as well as verbal assurance that adequate birth control measures have been followed for 60 days prior to the first vaccine/placebo vaccination and will continue to be followed for at least 3months after the final vaccine/placebo vaccination. This means using any of the following methods: Birth control drugs that prevent pregnancy given by pills, shots or placed under the skin, Male or female condoms with or without a cream or gel that kills sperm, diaphragm or cervical cap with a cream or gel that kills sperm, or Abstinence
排除标准
- •A volunteer will be excluded if one or more of the following conditions apply.
- •A woman who:
- •Is pregnant.
- •Is breast-feeding.
- •Anyone who:
- •Is U.S. military personnel.
- •Acknowledges engaging in highest-risk behavior within six months of study entry
- •Has active tuberculosis or other systemic infectious process by review of systems and physical examination.
- •Has history of or known cardiac disease including any of the following: prior myocardial infarction (heart attack), angina pectoris, congestive heart failure, conduction disturbances, repolarization (ST segment or T wave) abnormalities, serious cardiac arrhythmias (ventricular tachycardia or ventricular fibrillation), cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity (e.g. climbing stairs), valvular heart disease including mitral valve prolapse, or other heart conditions under the care of a doctor.
- •Has ECG on Screening Visit 2 with clinical significant findings, or features that would interfere with the assessment of myo/pericarditis (as determined by the contract ECG Lab) including any of the following: conduction disturbance (atrioventricular or intraventricular condition, left or right bundle branch block, AB block of any degree or QTc prolongation), repolarization (ST segment or T wave) abnormality, significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy (e.g. frequent premature atrial contractions, 2 premature ventricular contractions in a row), ST elevation consistent with ischemia, or evidence of past or evolving myocardial infarction
- •Has history of seizure disorder, immunodeficiency, chronic illness, autoimmune disease, diabetes mellitus active malignancy or use of immunosuppressive medications.
- •Has evidence of psychiatric, medical and/or substance abuse problems during the past six months that the investigator believes would adversely affect the volunteer's ability to participate in the trial.
- •Has occupational or other responsibilities that would prevent completion of participation in the study.
- •Has received any live attenuated vaccine within 60 days of study entry.
- •Has used experimental therapeutic agents within 30 days of study entry.
- •Has received blood products or immunoglobulins in the past three months.
- •Has history of anaphylaxis or other serious adverse reactions to vaccines.
- •Has previously received an HIV vaccine or an MVA or vaccinia vaccine.
- •Has chronic or active Hepatitis B or Hepatitis C virus infection or active syphilis (positive RPR and FTA).
- •Has had an immediate type hypersensitivity reaction to eggs, egg products or neomycin/streptomycin (used to prepare MVA vaccine).
- •Is a study site employee.
研究组 & 干预措施
Group II Placebo
Placebo Comparator
干预措施: Placebo (Biological)
Group III Placebo
Placebo Comparator
干预措施: Placebo (Biological)
Group IV Placebo
Placebo Comparator
干预措施: Placebo (Biological)
Group I Placebo
Placebo Comparator
干预措施: Placebo (Biological)
Group I Vaccine
Experimental
干预措施: MVA-CMDR (Biological)
Group II Vaccine
Experimental
干预措施: MVA-CMDR (Biological)
Group IV Vaccine
Experimental
干预措施: MVA-CMDR (Biological)
Group III Vaccine
Experimental
干预措施: MVA-CMDR (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: Study Day 0 through 8 months post-vaccination
Evaluate the safety and tolerability of MVA-CMDR (HIV-1 CM235 Env/CM240 Gag/Pol) administered by IM or ID injection to HIV uninfected adults
次要结局
- Immunogenicity(Study Day 0 through Study Day 280)
研究者
研究点 (2)
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