PACTR2010050002122368已完成未知
A Phase I/II trial to assess safety and immunogenicity of i.d. DNA priming, i.m. MVA and i.m. rgp140/GLA-AF boosting in healthy volunteers in Tanzania and to develop further HIV vaccine trial capacity building in Tanzania
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 40 Year(s)（—）
- 性别
- All
入选标准
- •1. Age: 18 to 40 years
- •2. Willing to undergo counseling and HIV testing
- •3. Have a negative antigen/antibody ELISA for HIV infection
- •4. Able to give informed consent
- •5. Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test.
- •6. Basic abilities to read and write.
- •7. Resident in Dar es Salaam or Mbeya, and willing to remain so for the duration of the study
- •8. At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior
- •9. Verbal assurances that adequate birth control measures are used not to conceive/father a child during the study and up to 3 months after the last vaccine injection
- •10. Women shall have a negative urinary pregnancy test
- •11. Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV.
- •12. Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters as judged by the study physician.
排除标准
- •1. At risk of HIV infection as mentioned above in the inclusion criteria
- •2. Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection (for example detection of Hepatitis B surface antigen, or active syphilis).
- •3. A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
- •4. Autoimmune disease by history and physical examination.
- •5. Hives or recurrent hives and severe eczema
- •6. A history of psychiatric, medical (including traditional medicine) and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial.
- •7. History of grand-mal epilepsy, or currently taking anti-epileptics
- •8. Received blood or blood products or immunoglobulins in the past 3 months.
- •9. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
- •10. Use of experimental therapeutic agents within 30 days of study entry.
- •11. Reception of any live, attenuated vaccine within 60 days of study entry. {NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions}.
- •12. Abnormality in ECG that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures.
- •13. Previously received an HIV candidate vaccine.
- •14. History of severe local or general reaction to vaccination in the past
- •15. Lactating mother
- •16. Study site employees who are involved in the protocol
- •17. Ulikeliness of protocol compliance
研究者
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