PER-052-06已完成未知
Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Protein Vaccine EP-1043 and the HIV-1090 EP DNA Vaccine Administered Separately and Combined to Healthy Adult Participants, Not Infected with HIV-1
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 个研究点目标入组 0 人开始时间: 2006年10月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
入选标准
- •1) Age: 18 to 50 years.
- •2) Access to a participating HIV Vaccine Trial Unit and willingness to be followed for the planned duration of the study.
- •3) Assessment of understanding: Complete a questionnaire prior to first vaccination; verbalize understanding of all questions answered incorrectly.
- •4) Willingness to receive HIV test results.
- •5) Informed consent: Be able and willing to provide informed consent
- •6) Health: Be in good general health as shown by medical history, physical exam, and screening laboratory tests performed within 56 days of enrollment.
- •7) Hemoglobin: ≥ sex-specificc institutional lower limit of normal and at least 11.0 g/dL for women, 12.5 g/dL for men.
- •8) WBC count = 3,300 to 12,000 cells/mm3.
- •9) Total lymphocyte count > 800 cells/mm3.
- •10) Remaining differential either within institutional normal range or accompanied by site physician approval.
- •11) Platelets = 125,000 to 550,000/mm3.
- •12) Chemlstry panel: Part A: ALT, AST, alkaline phosphatase, and creatinine values do not exceed institutional upper limit of normal, and CPK value does not exceed 2 times the institutional upper limit of normal; Part B: ALT, AST, and alkaline phosphatase do not exceed 1.25 times the institutional upper limit of normal; creatinine does not exceed institutional upper limit of normal.
- •13) Negative HIV blood test. US participants must have a negative FDA-approved ELISA test. Non-US sites will use locally available and locally approved assays.
- •14) Negative Hepatitis B surface antigen (HBsAg).
- •15) Negative anti-HepatitIs C virus antibodies, or negative HCV PCR if the anti-HCV is positive
- •16) Normal urine test.
- •17) Negative serum or urine B-HCG pregnancy test performed on the day of initial vaccination prior to vaccination
- •18) Reproductive status: a female participant must: a) Agree to consistently use contraception for at least 21 days prior to enrollment until the last protocol visit. b) Not be of reproductive potential, such as having reached menopause or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation. c) Agree not to seek pregnancy through altemative methods such as artificial insemination or in vitro fertilization until last protocol visit.
排除标准
- •1) Age: 18 to 50 years.
- •2) Access to a participating HIV Vaccine Trial Unit and willingness to be followed for the planned duration of the study.
- •3) Assessment of understanding: Complete a questionnaire prior to first vaccination; verbalize understanding of all questions answered incorrectly.
- •4) Willingness to receive HIV test results.
- •5) Informed consent: Be able and willing to provide informed consent
- •6) Health: Be in good general health as shown by medical history, physical exam, and screening laboratory tests performed within 56 days of enrollment.
- •7) Hemoglobin: ≥ sex-specificc institutional lower limit of normal and at least 11.0 g/dL for women, 12.5 g/dL for men.
- •8) WBC count = 3,300 to 12,000 cells/mm3.
- •9) Total lymphocyte count > 800 cells/mm3.
- •10) Remaining differential either within institutional normal range or accompanied by site physician approval.
- •11) Platelets = 125,000 to 550,000/mm3.
- •12) Chemlstry panel: Part A: ALT, AST, alkaline phosphatase, and creatinine values do not exceed institutional upper limit of normal, and CPK value does not exceed 2 times the institutional upper limit of normal; Part B: ALT, AST, and alkaline phosphatase do not exceed 1.25 times the institutional upper limit of normal; creatinine does not exceed institutional upper limit of normal.
- •13) Negative HIV blood test. US participants must have a negative FDA-approved ELISA test. Non-US sites will use locally available and locally approved assays.
- •14) Negative Hepatitis B surface antigen (HBsAg).
- •15) Negative anti-HepatitIs C virus antibodies, or negative HCV PCR if the anti-HCV is positive
- •16) Normal urine test.
- •17) Negative serum or urine B-HCG pregnancy test performed on the day of initial vaccination prior to vaccination
- •18) Reproductive status: a female participant must: a) Agree to consistently use contraception for at least 21 days prior to enrollment until the last protocol visit. b) Not be of reproductive potential, such as having reached menopause or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation. c) Agree not to seek pregnancy through altemative methods such as artificial insemination or in vitro fertilization until last protocol visit.
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