A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING CLINICAL

I 期、随机、双盲、安慰剂对照、剂量范围临床

基本信息

批准号：
7606207
负责人：
ChrisAnna Mink
金额：
$ 4.57万
依托单位：
LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-02-01 至 2007-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7606207
关键词：
Adjuvant Adult Adverse event Age-Years Aluminum Hydroxide Antibody Formation Biological Assay Blood Blood specimen Child Clinic Clinic Visits Clinical Computer Retrieval of Information on Scientific Projects Database Creatinine Data Dose Dose-Limiting Double-Blind Method Enrollment Evaluation Funding Grant Human Resources Immunization Institution Laboratories Licensing Memory Monitor Oral Participant Pharmaceutical Preparations Phase Physical Examination Placebo Control Placebos Platelet Count measurement Pre-study Pregnancy Pregnancy Tests Procedures Randomized Range Reporting Research Research Personnel Resources Safety Saline Screening procedure Serum Signs and Symptoms Site Source Staging Temperature Testing Toxic effect United States National Institutes of Health Upper arm Urine Vaccination Vaccines Visit Week cost day follow-up influenza virus vaccine neutralizing antibody

项目摘要

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. This is a NIH-sponsored, multicenter randomized, partially-blinded (investigator, safety data collectors), placebo-controlled, dose-ranging study of A/H5N1 influenza vaccine in approximately 300 healthy adults, 18 to 40 years of age. At this site, it is anticipated that 75-90 adults may take part in the study. Each subject's participation will last about 7 months. Subjects will be randomly assigned to one of six study groups (50 subjects per group) and will receive 2 doses of either: 1) saline placebo, 2) 7.5 mcg A/H5N1 influenza vaccine with adjuvant (aluminum hydroxide), 3) 7.5mcg vaccine without adjuvant, 4) 15 mcg vaccine with adjuvant, 5) 15mcg vaccine without adjuvant, or 6) 45mcg without adjuvant. The vaccine will be given intramuscularly in the upper arm with the doses administered ~28 days apart. For subjects of child-bearing potential, a urine pregnancy test must be negative prior to administration of each vaccine dose. Symptoms and signs will be assessed in the clinic for 15-30 minutes after inoculation, and the subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 7 days after each immunization. Subjects will visit the clinic 1 to 3 days after vaccination and study personnel will assess concomitant medication and AEs. A targeted physical examination will be performed if indicated. This will be reported on Day 7 when they return to the clinic for a blood sample. The second vaccination will occur at approximately day 28 and the same post vaccination procedures and visits will take place. At approximately day 208 (6 months after the second vaccination), subjects will return to the clinic for follow-up which includes a final blood sample and a targeted physical examination if indicated. The HA and neutralizing antibody response assays will be performed in a central laboratory. The study will be conducted in 2 stages. In stage 1, 90 subjects will be enrolled (15 per study group). Blood samples for safety evaluations (WBC, Hgb, platelet count, ALT, serum creatinine, serum pregnancy) will be obtained at a pre-study screening visit and before and one week after each vaccination. The Safety Monitoring Committee (SMC) will meet approximately 10 days after the enrollment of subjects in stage 1 to review clinical and laboratory data safety data. If no clinical or laboratory safety-related issues or dose-limiting toxicity are noted during the week after administration of each dose of vaccine during stage 1, then 210 additional subjects will be enrolled into each vaccine group during stage 2. The additional blood for safety laboratory tests will not be collected for subjects in stage 2. For subjects in Stage 1, NIH will provide an option to receive the regular licensed flu vaccine. Participants will be offered the vaccine at no cost when they come for Visit 7 (day 56). Subjects in Stage 2 will be encouraged to receive their flu vaccine prior to study participation (2 weeks for inactivated flu vaccine). Stage 2 is expected to take place after all Stage 1 participants have received their vaccines, so enrollment for Stage 2 will occur around January 2007.

该副本是利用众多研究子项目之一由NIH/NCRR资助的中心赠款提供的资源。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构是对于中心，这不一定是调查员的机构。这是一项由NIH赞助的，多中心的随机，部分盲（研究人员，安全数据收集器），安慰剂控制的，剂量的研究，对大约300名健康成年人，18至40岁的A/H5N1流感疫苗的研究。在此地点，预计75-90名成年人可能会参加这项研究。每个受试者的参与将持续约7个月。受试者将随机分配给六个研究组之一（每组50名受试者），并将接受2剂的剂量：1）盐安慰剂，2）7.5 mcg A/H5N1流感疫苗与辅助剂（氧化铝铝）（3）7.5MCG疫苗，无需辅助疫苗。 45mcg无辅助。该疫苗将在上臂的肌肉内给予，剂量相隔约28天。对于育儿潜力的受试者，在服用每种疫苗剂量之前，尿液妊娠试验必须为阴性。接种后，将在诊所评估症状和体征，并将受试者保持记忆辅助，以记录口服温度以及每次免疫后7天的口腔温度以及全身和局部不良事件（AES）。疫苗接种后1至3天，受试者将访问诊所，研究人员将评估伴随的药物和AE。如果指示，将进行有针对性的身体检查。这将在第7天返回诊所以获取血液样本的报道。第二次疫苗接种将在大约28天发生，并将进行相同的疫苗接种程序和访问。在大约208天（第二次疫苗接种后6个月），受试者将返回诊所进行随访，其中包括最终的血液样本和有针对性的身体检查。 HA和中和抗体反应测定将在中央实验室进行。该研究将分为两个阶段进行。在第1阶段，将招募90名受试者（每个研究组15名）。用于安全评估的血液样本（WBC，HGB，血小板计数，ALT，血清肌酐，血清妊娠）将在每次疫苗接种后的前筛查前以及一周后获得。安全监测委员会（SMC）将在第1阶段入学后大约10天，以审查临床和实验室数据安全数据。如果在第1阶段服用每种剂量的疫苗后的一周内未发现与临床或实验室安全有关的问题或剂量限制性毒性，那么在第2阶段期间，将招募210名其他受试者。在第2阶段，每个疫苗组都将在第2阶段的安全实验室测试中接受安全实验室测试的额外血液。对于第1阶段的受试者，NIH将提供一种接收常规许可流感疫苗的选择。当参与者来参观7（第56天）时，将免费提供疫苗。在研究参与之前，将鼓励第2阶段的受试者接受其流感疫苗（灭活流感疫苗2周）。预计所有第1阶段参与者收到了疫苗后，第2阶段将进行，因此第2阶段的入学率将在2007年1月左右发生。