CLINICAL TRIAL: CIRCUMSPOROZOITE MALARIA VACCINE IN HEALTHY ADULTS 18 TO 45 YEAR

临床试验：环孢子疟疾疫苗在 18 至 45 岁健康成年人中的应用

• 批准号: 7717936
• 负责人: CORNELIA L DEKKER
• 金额: $ 2.53万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717936
• 关键词: Academic Medical Centers; Adenoviruses; Adult; California; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Enrollment; Female; Funding; Grant; Institution; Intramuscular; Intramuscular Injections; Malaria Vaccines; Normal saline; Placebo Control; Randomized; Research; Research Personnel; Resources; Route; Safety; Serious Adverse Event; Site; Source; Telephone; Tennessee; United States; United States National Institutes of Health; Universities; Vaccines; Viral; aged; circumsporozoite; dosage; immunogenicity; male; particle; volunteer

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The study will enroll a total of 96 healthy male and female volunteers aged 18 to 45 years in the United States. Participating sites include Vanderbilt University Medical Center, Nashville, Tennessee and Stanford University, Stanford California. The study duration will be approximately 7 months per subject, to be followed by annual phone calls for a period of five years for serious adverse event assessment. The investigational agent is an Adenovirus Type 35 Circumsporozoite Malaria Vaccine (Ad35.CS.01) which will be compared with a Normal Saline Placebo Control via Intramuscular Injection. Volunteers will be randomized in a 5:1 ratio to receive 3 doses of the vaccine or normal saline placebo control by the intramuscular route at 0, 1 and 6 months. The safety, reactogenicity and immunogenicity of ascending dosages of the vaccine will be assessed. Fifteen volunteers will receive vaccine at each of the following dosage levels: 108 viral particles (vp)/ml and 109vp/ml with three volunteers receiving placebo control at each of these dosage levels. Twenty-five volunteers will receive vaccine at each of the next dosage levels of 1010vp/ml and 1011vp/ml with five volunteers receiving placebo control at each of these dosage levels. Dosage escalation will proceed only after review of the safety data after the initial dose of the prior dosage level.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 该研究将在美国招募总共96名年龄在18至45岁之间的健康男性和女性志愿者。 参与的地点包括范德比尔特大学医学中心，纳什维尔，田纳西州和斯坦福大学，斯坦福大学加州。 每例受试者的研究持续时间约为7个月，之后每年进行一次电话随访，为期5年，以评估严重不良事件。 研究药物是腺病毒35型环子孢子疟疾疫苗（Ad35.CS.01），将通过肌内注射与生理盐水安慰剂对照进行比较。 志愿者将以5：1的比例随机分配，在0、1和6个月时通过肌内途径接受3剂疫苗或生理盐水安慰剂对照。将评估疫苗剂量递增的安全性、反应原性和免疫原性。15名志愿者将接受以下剂量水平的疫苗：108病毒颗粒（vp）/ml和109 vp/ml，3名志愿者接受这些剂量水平的安慰剂对照。25名志愿者将接受1010 vp/ml和1011 vp/ml剂量水平的疫苗，5名志愿者接受这些剂量水平的安慰剂对照。仅在既往剂量水平的首次给药后审查安全性数据后，才可进行剂量递增。