CLINICAL TRIAL: INFLUENZA VACCINE ALONE OR WITH ALUMINUM HYDROXIDE TO HEALTHY YO

临床试验：单独使用流感疫苗或与氢氧化铝一起使用可保持健康

• 批准号: 7717917
• 负责人: CORNELIA L DEKKER
• 金额: $ 4.31万
• 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/7717917
• 关键词: Adjuvant; Administrator; Alanine Transaminase; Alcohol or Other Drugs use; Aluminum Hydroxide; Bird Flu vaccine; Blinded; Blood; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Creatinine; Data; Dose; Dose-Limiting; Double-Blind Method; Effectiveness; Enrollment; Evaluation; Funding; Grant; Hemoglobin; Human Resources; Immune response; Influenza; Influenza A Virus, H5N1 Subtype; Institution; Intramuscular; Intramuscular Injections; Laboratories; Monitor; Phase; Placebo Control; Placebos; Platelet Count measurement; Preparation; Procedures; Purpose; Randomized; Range; Research; Research Personnel; Resources; Route; Safety; Saline; Screening procedure; Serum; Site; Source; Staging; Toxic effect; Treatment Protocols; United States National Institutes of Health; Vaccination; Vaccines; Vero Cells; Week; White Blood Cell Count procedure; aged; cohort; day; design; dosage; immunogenicity; influenza virus vaccine; influenzavirus; young adult

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 purpose of this study is to determine the safety and effectiveness of an avian flu vaccine given with or without an adjuvant, a substance used to boost the immune response. The information will be used to design a an avian flu vaccine which could produce an effective immune response at the lowest effective dose. This is a Phase I, multicenter, staged, randomized, double-blind, placebo-controlled, dosage ranging study of the safety, reactogenicity, and preliminary immunogenicity of a Vero cell-grown, inactivated, whole virus influenza A/H5N1 vaccine administered with or without aluminum hydroxide adjuvant by the intramuscular (IM) route as a 2-dose regimen (Day 0 and Day 28). Approximately 300 healthy young adults (aged 18 to 40 years inclusive) will be enrolled by five sites. Subjects will be enrolled over a 2-3 month period. The Stanford site expects to enroll a total of about 60 subjects-15-20 subjects in Stage 1 and 40-45 subjects in Stage 2. Each subject will be randomly assigned to receive 2 doses of either saline placebo, or 7.5 or 15 ?g of the influenza A/H5N1 virus vaccine with or without aluminum hydroxide, or 45 ?g of the influenza A/H5N1 virus vaccine without aluminum hydroxide (N=50/dose group) by IM injection. Vaccine preparation and administration will be performed by an unblinded vaccine administrator, who will not be involved in subsequent study procedures. All study assessments will be performed by blinded study personnel and subjects will be blinded as much as practical to treatment assignment. The study will be conducted in 2 stages (1 and 2). During Stage 1, 90 subjects who meet the entry criteria for the study will be randomized to receive saline placebo or 7.5 mg (with or without aluminum hydroxide), 15 mg (with or without aluminum hydroxide), or 45 mg (without aluminum hydroxide) (6 groups; N=15 per group). Blood for safety evaluations (including total white blood cell count [WBC], hemoglobin [Hgb], platelet count, alanine aminotransferase [ALT], and serum creatinine) will be obtained from all subjects in Stage 1 cohort at screening, and before and 1 week after each vaccination. The Safety Monitoring Committee (SMC) will meet approximately 10 days after enrollment and completion of first vaccination of subjects in Stage 1 to review available clinical and laboratory safety data. If no clinical or laboratory safety-related issues or dose-limiting toxicities are noted during the week after administration of the first dose of vaccine during Stage 1, then all Stage 1 subjects will receive second vaccination. Furthermore, the SMC will meet to review a complete clinical and laboratory safety data package for Stage 1 prior to initiation of the enrollment of 210 additional subjects into each vaccine group during Stage 2 (N=50 per group total).

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是确定使用或不使用佐剂（一种用于增强免疫反应的物质）的禽流感疫苗的安全性和有效性。 这些信息将用于设计一种禽流感疫苗，该疫苗可以以最低的有效剂量产生有效的免疫反应。 这是一项 I 期、多中心、分阶段、随机、双盲、安慰剂对照、剂量范围研究，研究使用 Vero 细胞生长的灭活全病毒 A/H5N1 流感疫苗的安全性、反应原性和初步免疫原性或不使用氢氧化铝佐剂，通过肌内 (IM) 途径作为 2 剂量方案（第 0 天和第 28 天）。 五个站点将招募大约 300 名健康的年轻人（18 岁至 40 岁）。 受试者将在 2-3 个月内注册。 斯坦福大学预计总共招募约 60 名受试者，其中第一阶段为 15-20 名受试者，第二阶段为 40-45 名受试者。每位受试者将被随机分配接受 2 剂生理盐水安慰剂，即 7.5 或 15 µg含或不含氢氧化铝的甲型/H5N1 流感病毒疫苗，或不含氢氧化铝的甲型/H5N1 流感病毒疫苗 45 µg（N=50/剂）组）通过肌内注射。 疫苗的制备和给药将由不盲的疫苗管理员进行，该管理员不会参与后续的研究程序。 所有研究评估将由盲法研究人员进行，并且受试者将尽可能对治疗分配进行盲法。 该研究将分两个阶段（1 和 2）进行。在第一阶段，符合研究进入标准的 90 名受试者将被随机接受盐水安慰剂或 7.5 毫克（含或不含氢氧化铝）、15 毫克（含或不含氢氧化铝）或 45 毫克（不含氢氧化铝） （6组；每组N=15）。 用于安全性评估的血液（包括总白细胞计数 [WBC]、血红蛋白 [Hgb]、血小板计数、丙氨酸氨基转移酶 [ALT] 和血清肌酐）将从筛选时、之前和 1 阶段队列中的所有受试者获取每次疫苗接种后一周。 安全监测委员会 (SMC) 将在第一阶段受试者入组和完成首次疫苗接种后约 10 天举行会议，审查现有的临床和实验室安全数据。 如果在第一阶段接种第一剂疫苗后一周内没有发现临床或实验室安全相关问题或剂量限制性毒性，则所有第一阶段受试者将接受第二次疫苗接种。 此外，在第 2 阶段期间开始将 210 名额外受试者纳入每个疫苗组（每组总数 N=50）之前，SMC 将召开会议审查第 1 阶段的完整临床和实验室安全数据包。