PH I/II PROOF OF CONCEPT TRIAL OF ANTHRAX VACCINE COMBINED WITH CPG 7909

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心，不一定是研究者所在机构。目的：目的是探索人免疫系统应答的特征和动力学以及炭疽吸附疫苗（AVA）与CpG 7909的组合在以三次肌内注射（i.m.）每次注射间隔两周。 研究报告：本研究将是一项概念验证、双盲、随机、对照试验，比较AVA联合CpG与单独AVA或单独CpG 7909注射。 方法：将75名正常志愿者随机分为三组（每组25人）。雄性和雌性动物将分别随机分组。参与者将获得三个i. m。在研究第0、2和4周注射研究药物。将在筛选时和整个研究期间的不同时间点采集血液，以评估免疫学结局指标。将在筛选和研究结束时采集血液和尿液，以评估安全性参数（血生化和血液学、感染性疾病血清学、自身免疫性疾病标志物和尿分析）。将在每次临床访视时评估不良事件。 临床相关性：这项临床试验的目的是采取措施解决如何加速对炭疽的保护性免疫反应。 截至2005年3月31日，2004年随机分组的7例受试者完成了计划的6个月安全性随访问卷。这7例受试者未报告新的医学问题或其他不良事件。 截至2005年3月31日，所有受试者均未发生严重不良事件。 两个研究中心的研究总入组人数为135例受试者，66例被排除，69例被随机分配接受研究注射。

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. OBJECTIVE: The objectives are to explore the characteristics and kinetics of the human immune system response as well as the safety profile of the combination of Anthrax Vaccine Adsorbed (AVA) with CpG 7909 when given as three intramuscular injections (i.m.) with each injection given two weeks apart. RESEARCH PLAN: This study will be a proof-of-concept, double-blind, randomized, controlled trial comparing AVA combined with CpG to AVA alone or CpG 7909 injection alone. METHODS: Approximately 75 normal volunteers will be randomized equally to one of the three groups (25 per group). Males and females will be separately randomized. Participants will be given three i.m. injections of investigational agents at study weeks 0, 2, and 4. Blood will be collected at screening and at various time points throughout the study period to assess immunological outcome measures. Blood and urine will be collected at screening and study end to assess safety parameters (blood chemistry and hematology, infectious diseases serology, autoimmune disease markers, and urinalysis). Adverse events will be assessed at each clinic visit. CLINICAL RELEVANCE: It is the intent of this clinical trial to take steps in addressing how to accelerate the protective immune response against anthrax. The scheduled six month safety follow-up questionnaire was completed by 7 subjects from the 2004 randomization group by 3/31/05. No new medical problems or other adverse events were reported by these 7 subjects. No serious adverse events have been noted for all subjects through 3/31/05. Total enrollment for the study at both sites is 135 subjects, 66 were excluded, and 69 were randomized to receive study injections.