PER-065-06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
ational Health Institute(Division Sida),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 old.
- •2) Access to a HIV Vaccine Clinical Trials Unit that participates and the willingness to receive follow-up for the duration planned for the study.
- •3) Complete a questionnaire before the first vaccination, express that you have understood all the questions that were answered incorrectly.
- •4) Willingness to receive the results of the HIV analysis.
- •5) Informed consent: Have the possibility and willingness to give informed consent.
- •6) Hemoglobin ≥ institutional normal limit specific to sex and at least 11.0 g / dl for women. 12.5 g / dl for men.
- •7) WBC count = 3,300 to 12,000 cells / mm3.
- •8) Total lymphocyte count ≥ 800 cells / mm3.
- •9) The rest of the differential within the normal institutional limit or accompanied by the approval of the center´s doctor.
- •10) Platelets = 125,000 to 550,000 / mm3.
- •11) Chemistry panel: Part A: The values of ALT, AST, alkaline phosphatase and creatinine do not exceed the upper normal institutional limit and the CPK value does not exceed twice the higher institutional normal value. Part B: the values of ALT, AST and alkaline phosphatase do not exceed the upper normal institutional limit in 1.25 times; creatinine does not exceed the upper normal institutional limit.
- •12) Blood test negative for HIV.
- •13) Surface antigen for Hepatitis B (HBsAg) negative.
- •14) Antibodies to the hepatitis C virus (anti-HCV) negative, or PCT negative to HCV if the anti-HCV test is positive
- •15) Normal urine test.
- •16) Pregnancy test of B-HCG in serum or urine made on the day of the initial vaccination, before the same.
- •17) Reproductive status; a female participant must: a) Agree to use contraception consistently from a minimum of 21 days before enrollment until the last protocol visit. OR b) Not have reproductive capacity. c) Agree not to seek pregnancy by alternative methods such as artificial insemination or in vitro fertilization until the last visit of the protocol.
排除标准
- •1) The participant has received one of the following substances: a) Vaccine (s) for HIV in a previous study. b) Immunosuppressive drugs in a period of 168 days before the first vaccination. c) Hemoderivates in a period of 120 before the first vaccination. d) Immunoglobulin in a period of 60 days before the first vaccination. e) Vaccines to live attenuated virus within 30 days before the first vaccination. f) Experimental research agents in a period of 30 days before the first vaccination. g) Vaccines of subunits or killed virus by medical indication. h) Prophylaxis or current anti-TB treatment.
- •2) The participant has a clinically significant medical condition, findings on the physical examination, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health.
- •3) Any medical, psychiatric or social or occupational or other liability that interferes with, or would be a contraindication to adherence to the protocol, the assessment of safety or reactogenicity, the ability of a participant to give informed consent.
- •4) Severe adverse reactions to vaccines.
- •5) Autoimmune disease.
- •6. Immunodeficiency.
- •7) Infection by active syphilis.
- •8) Asthma that is not mild or well controlled.
- •9) Diabetes mellitus type I or type II.
- •10) Thyroid disease or thyroidectomy that required medication during the last 12 months.
- •11) Angioedema within the last 3 years if the episodes are considered serious or have required medication during the past 2 years.
- •12) Hypertension: a) If a person has been diagnosed with hypertension during the screening or before, exclude those whose hypertension is not well controlled. b) If a person is NOT diagnosed with hypertension during selection or earlier, it will be excluded if: Systolic blood pressure ≥ 150 mm Hg at the time of enrollment OR Diastolic blood pressure ≥ 100 mm Hg at the time of enrollment.
- •13) BMI ≥ 40; or, BMI ≥ 35 with more than 1 of the following: age> 45, systolic blood pressure> 140 mm Hg, diastolic blood pressure> 90 mm Hg, smoking, known hyperlipidemia.
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