PACTR201106000304583招募中未知
A Phase I trial to assess safety and immunogenicity of i.d. DNA priming and i.m. MVA boosting in healthy volunteers in Mozambique and to develop further HIV vaccine trial capacity building in Mozambique
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 24
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 26 Year(s)（—）
- 性别
- All
入选标准
- •1. Age: 18 to 26 years
- •2. Willing to undergo HIV counseling and testing
- •3. Have a negative antigen/antibody or antibody ELISA for HIV infection
- •4. Able to give informed consent
- •5. Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test
- •6. Basic abilities to read and write
- •7. Resident in Maputo, 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 (their presence is therefore an exclusion criteria):
- •sexual partner with HIV
- •sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations
- •sexual partner is known to be at high risk for HIV
- •more than one sexual partner in the last 6 months
- •history of being an alcoholic [as medically defined or more than 35 units /week]
- •history of STI within past 6 months
- •9. Verbal assurances that adequate birth control methods 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 urine 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.
- •13. Laboratory criteria:
- •Hb >10.5g/dl
- •White blood cell count <13,000/mm3
- •Neutrophils >1,300/mm3
- •Lymphocytes >1.000/ mm3
- •Platelets >120,000/ mm3
- •Random Blood Glucose < 6.44 mmol/L; if elevated, then a Fasting Blood Glucose < 6.11mmol/L (according to DAIDS Table for Lab Criteria)
- •Bilirubin <1.25 x uln
- •ALT <1.25 x uln
- •Creatinine <1.25 x uln
- •Urine dipstick for protein and blood: negative or trace. (If either is ¿ 1+, complete urinalysis (UA) will be performed.
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
- •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 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.
- •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 vaccine candidate
- •14. History of severe local or general reaction to vaccination defined as:
- •Local: Extensive, indurate redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours
- •General: Fever >= 39.5 0C within 48 hours; anaphylaxis; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours
- •15. Being a lactating mother
- •16. Study site employees who are involved in the protocol and may have direct access to the immunogenicity results
- •17. Unlikely to comply with protocol as judged by the principal investigator or his designate.
研究者
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