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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：目的是探讨吸附炭疽疫苗（AVA）与CpG 7909联合肌内注射（i.m）三次，每次注射间隔两周时，人体免疫系统反应的特征和动力学以及安全性。研究计划：该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或单独注射CpG 7909。方法：大约75名正常志愿者将被随机分为三组（每组25人）。男性和女性将分别随机抽取。在研究第0、2和4周，参与者将接受三次静脉注射研究药物。将在筛查时和整个研究期间的不同时间点采集血液，以评估免疫结果措施。在筛选和研究结束时将收集血液和尿液以评估安全性参数（血液化学和血液学、传染病血清学、自身免疫性疾病标志物和尿液分析）。不良事件将在每次就诊时进行评估。临床意义：本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。2004随机分组的7名受试者于2005年3月31日前完成预定的6个月安全随访问卷。这7名受试者未出现新的医学问题或其他不良事件。截至2005年3月31日，所有受试者均未发现严重不良事件。两个研究中心的总入组人数为135名受试者，66名被排除，69名随机接受研究注射。

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.