NCT01697007已完成2 期
A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 3
- 主要终点
- The presence of an interferon gamma ELISpot responses to a pool of HIV peptides encoded by the vaccine to which there was no response at baseline
研究概览
简要总结
Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Willing to undergo counselling and HIV testing.
- •Have a negative antigen/antibody ELISA for HIV infection.
- •Able to give informed consent.
- •Basic abilities to read and write.
- •Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test.
- •Resident of the region where the study is taking place.
- •At low risk of HIV infection.
- •Verbal assurances for adequate birth control measures.
- •Healthy as evidenced by clinical and laboratory measures
排除标准
- •At risk of HIV infection.
- •Active tuberculosis.
- •A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or chronic illness requiring continuous or frequent medical intervention.
- •Autoimmune disease.
- •Hives and severe eczema.
- •Substance abuse problems.
- •History of grand-mal epilepsy.
- •Received blood or blood products or immunoglobulins in the past 3 months.
- •Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
- •Use of experimental therapeutic agents within 30 days of study entry.
- •History of cardiac disease
结局指标
主要结局
The presence of an interferon gamma ELISpot responses to a pool of HIV peptides encoded by the vaccine to which there was no response at baseline
时间窗: 2 weeks after the last vaccination
Grade 3 or above local and systemic solicited adverse events
时间窗: Within 2 weeks post each immunization up to week 64 from enrollment
次要结局
- The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining(2 weeks post last vaccination)
研究者
Patricia Jane Munseri
Prof Eligius Lyamuya
Muhimbili University of Health and Allied Sciences
研究点 (3)
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