NCT00369031终止1 期
A Phase I, Open Label, Parallel Group Trial To Evaluate Safety And Immunogenicity Of Three Nasal Immunisations Using A Fixed Dose-Level Of HIV gp140 V2 Loop Deleted Protein Adjuvanted With LTK63 Followed By Intramuscular Boosting With HIV gp140 V2 Loop Deleted Protein Adjuvanted With MF59 When Administered To Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32
研究概览
简要总结
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken.
详细描述
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken by measuring gp140- and LTK63-specific IgG and IgA in cervical secretions, vaginal secretions, serum and nasal wash. IFNg secretion of T cells in response to gp140 peptide stimulation will be undertaken along with neutralising assays.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are adult volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
- •They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
- •They are available for the duration of the study
- •They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period.
排除标准
- •They have hypersensitivity to any component of the vaccines used in this study.
- •They are found to be HIV antibody positive at the time of initial screening
- •They have a known or suspected history of nasal disease, malignancy or abnormality, or any nasal disease, malignancy or abnormality discovered at time of screening.
- •They have a known or suspected history of severe seasonal allergies and allergic rhinitis (requiring medication), recurrent nose bleeds, asthma, or cardio-pulmonary disease, or any of these conditions discovered at time of screening.
- •They present in the samples obtained at the screening visit:
- •a clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick:
- •a clinically significant abnormality in the haematological or biochemical assays
- •An abnormal value will be defined by the ranges quoted in the St George's Pathology Services Handbook.
- •They have a known impairment of immune function or are receiving immunosuppressive therapy (including systemic or inhaled steroids, but excluding topical).
- •They are receiving any medications via nasal route.
- •They have any acute infections (including fever greater than or equal to 38°C) or any chronic disease.
- •They are women capable of becoming pregnant who do not agree to have pregnancy testing before application of study products, or who do not agree to take appropriate contraception measures during the whole study period. Appropriate contraception shall include physician-prescribed oral, injected or implanted hormonal agents; barrier contraceptives used in conjunction with spermicidal agents; or intrauterine devices only.
- •They present a current problem with substance abuse or with a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the study.
- •They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •They have received an investigational agent within 3 months prior to study entry.
- •They cannot speak fluent English, or are planning to leave the area of the study site prior to the end of the study period, or are likely not to complete the study.
- •They have a weight (W)/height (H) index (WHI) less than 18.5 or greater than 40
结局指标
主要结局
To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32
时间窗: 32 weeks
次要结局
- To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32(32 weeks)
- To determine the frequency of subjects mounting a nasal wash gp140-specific IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32(32 weeks)
- To determine frequency of subjects mounting a serum IgG response, nasal IgA response and vaginal IgA response to LTK63 at weeks 0, 4, 8, 10, 12, 16, 28 & 32(32 weeks)
- To determine the frequency of subjects mounting a serum IgG neutralising antibody response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32(32 weeks)
- To determine the frequency of subjects with a serum T-cell response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32(32 weeks)
- To determine the frequency of female subjects mounting a vaginal secretions IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32(32 weeks)
研究者
研究点 (2)
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