PER-008-07已完成未知
A Phase Ib Clinical Trial to Compare the Safety, Tolerability, and Immunogenicity of an HIV-1 Adenoviral Vector Boost Administered Intramuscularly, Intradermally, or Subcutaneously After an HIV-1 DNA Plasmid Vaccine Prime Administered Intramuscularly to Healthy Adenovirus Type 5 Seropositive HIV-1-Uninfected Adults
ASOCIACION CIVIL SELVA AMAZONICA,0 个研究点目标入组 18 人开始时间: 2007年4月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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
- 0 至 0（—）
入选标准
- •1) Age: From 18 to 50 years old.
- •2) Access to a HVTU that participates in the study and a willingness to receive follow-up during the planned duration of the study.
- •3) Assessment of comprehension: Complete a questionnaire before the first vaccination; express that they have understood all the questions that were answered incorrectly.
- •4) Good disposition to receive the results of the HIV test
- •5) Informed Consent: Be able and willing to provide informed consent.
- •6) Health: Have a good general health.
- •7) Neutralizing titers of Ad5 ≥ 1:12.
- •8) Hemoglobin ≥ than the institutional normal lower limit.
- •9) Number of leukocytes = from 3,300 to 12,000 cells / mm3.
- •10) Total number of lymphocytes ≥ 800 cells / mm3.
- •11) The rest of the leukocyte formula within normal limits.
- •12) Thrombocytes: From 125,000 - 550,000 / mm3.
- •12) ALT: 1.25 times lower than the upper normal institutional limit.
- •13) Creatinine: Does not exceed the upper normal institutional limit.
- •14) Negative test result of HIV-1/2.
- •15) Negative result in the analysis of the surface antigen of hepatitis B (HBsAg).
- •16) Negative result in the analysis of the antibodies against the hepatitis C virus (against HCV), or in the PCR for the HCV in case the analysis against the HCV is positive.
- •17) Normal urine test.
- •18) Negative result in the pregnancy test of B-HCG in serum or urine.
- •19) Reproductive status: A female participant must agree to use contraception consistently, from at least 21 days before enrollment until the last protocol visit.
排除标准
- •1) Vaccine (s) against HIV in a previous study of HIV vaccines.
- •2) Immunosuppressive drugs within 168 days before the first vaccination.
- •3) Blood products within 120 days before the first vaccination.
- •4) Immunoglobulin within 60 days before the first vaccination.
- •5) Attenuated vaccines within 30 days before the first vaccination.
- •6) Substances under investigation within 30 days before the first vaccination.
- •7) Vaccines of subunits or inactivated administered by medical indication.
- •8) Prevention or current treatment against tuberculosis: The participant suffers from a clinically significant disease, presents signs, clinically significant abnormalities are observed in the laboratory results, or has medical history with clinically significant sequelae for the current state of health.
- •9) Any medical, psychiatric, social or occupational disease or other situation that would interfere with, or be a contraindication to, adherence to the protocol, assessment of safety, reactogenicity, or the ability of a participant to give informed consent.
- •10) Serious adverse reactions to vaccines.
- •11) Autoimmune disease.
- •12) Immunodeficiency.
- •13) Infection by active syphilis.
- •14) Asthma.
- •15) Type I or type II diabetes, including cases controlled only with diet.
- •16) Thyroid disease or thyroidectomy that required medication during the last 12 months.
- •17) Angioedema in the last 3 years if the episodes are considered serious or have required medication during the last 2 years.
- •18) 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 has not been diagnosed with hypertension during the selection or before, exclude if he has a systolic blood pressure ≥ 150 mm Hg or diastolic ≥ 100 mm Hg in the inscription.
- •19) BMI ≥ 40 or BMI ≥ 35 plus one of the following: Age> 45 years, systolic blood pressure> 140 mm Hg, diastolic blood pressure> 90 mm Hg, known smoking or hyperlipidemia.
- •20) Haemorrhagic disorder diagnosed by a doctor.
- •21) Malignant neoplasm.
- •22) Convulsive disorder.
- •23) Asplenia.
- •24) Psychiatric illness that prevents compliance with the protocol.
研究者
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