EVALUATION OF IMVAMUNER SMALLPOX VACCINE WITH RESPECT TO SAFETY AND OPTIMIZATION

IMVAMUNER 天花疫苗的安全性和优化评估

• 批准号: 7952160
• 负责人: Christine B. Turley
• 金额: $ 0.99万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952160
• 关键词: Adverse effects; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Development; Dose; Enrollment; Evaluation; Event; Funding; Grant; Immune response; Immune system; Immunization; Individual; Institution; Placebos; Protocols documentation; Randomized; Readiness; Recommendation; Research; Research Personnel; Resources; Safety; Smallpox; Smallpox Vaccine; Source; Time; Toxic effect; United States National Institutes of Health; Vaccines; Visit; biodefense; diaries; follow-up; immunogenicity; improved

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. Development of safe, effective vaccines for protection against smallpox is an important component of national readiness in biodefense. The specific aims are to 1) establish the safety and clinical side effect profile of Imvamune Vaccine as compared to placebo and to Dryvax. 2) Understand the different components of the immune system that the vaccine activates to develop an immune response. 3) Understand the timing of protection in individuals receiving Imvamune in different doses and /or Dryvax for use in eventual development of recommendations in a post-event scenario for biodefense. In July, 2007, enrollment was halted at the request of CBER. The protocol has been modified as follows. One hundred and ninety-five subjects will be randomly assigned to one of three groups to be immunized twice with IMVAMUNE¿ vaccine or placebo subcutaneously in Groups A and B, or to receive a single immunization with IMVAMUNE¿ or placebo subcutaneously in Group F. (NOTE: A total of 197 subjects will be randomly assigned to Groups A, B, and F as two subjects were previously enrolled in Group B.) These individuals will come for follow up visits frequently in the month following vaccine, and then 6 and 12 months after receiving the first dose of vaccine. They will be asked to maintain a diary of side effects and will have lab studies done to evaluate for safety, toxicity and immune response. An alternative smallpox vaccine with an improved safety profile and immunogenicity profile is important to the nation's ability to strategically provide biodefense.

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。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 开发安全、有效的天花疫苗是国家生物防御准备工作的重要组成部分，具体目标是 1) 确定 Imvamune 疫苗与安慰剂和 Dryvax 相比的安全性和临床副作用。疫苗激活免疫系统的不同组成部分以产生免疫反应 3) 了解接受不同剂量的 Imvamune 和/或 Dryvax 的个体的保护时间，以便最终制定建议。生物防御的事后场景。 2007 年 7 月，应 CBER 的要求停止了招募。 方案修改如下： 195 名受试者将被随机分配到三组中的一组，接受两次 IMVAMUNE 免疫。 A 组和 B 组皮下注射疫苗或安慰剂，或接受 IMVAMUNE 单次免疫接种F 组皮下注射或安慰剂。（注：总共 197 名受试者将被随机分配到 A、B 和 F 组，因为之前有两名受试者被纳入 B 组。）这些人将在本月频繁进行随访接种第一剂疫苗后，以及接种第一剂疫苗后 6 个月和 12 个月，他们将被要求记录副作用日记，并进行实验室研究，以评估具有替代性天花疫苗的安全性、毒性和免疫反应。改善安全状况和免疫原性特征对于国家战略性提供生物防御的能力非常重要。