MVA SMALLPOX VACCINE IN ADULTS WITH AND WITHOUT PREVIOUS SMALLPOX VACCINE

曾接种或未接种过天花疫苗的成人 MVA 天花疫苗

• 批准号: 7380595
• 负责人: DANIEL SETH FIERER
• 金额: $ 0.38万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-17 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380595
• 关键词: Poxviridae disease; active immunization

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. Hypothesis: ACAM3000 smallpox vaccine has a highly favorable safety profile compared with the traditional smallpox vaccine and elicits an adequate immunological response to expect that it will be effective in preventing smallpox. Modified Vaccinia Ankara (MVA) is a strain of vaccinia that has been attenuated by serial passage in chick embryo fibroblasts (CEFs) and is essentially non-replicating in humans. It is believed, therefore, that MVA vaccine may provide effective protection against smallpox without the reactivity and severe side effects associated with replication-competent vaccinia vaccines. A vaccine based on MVA was tested in approximately 120,000 persons in Germany in the 1970s, and was licensed by the German national control authority for use as a pre-vaccination, to be followed by traditional vaccinia vaccine. The ACAM3000 MVA smallpox vaccine, which has a common origin with the German vaccine was subsequently developed in the US at the NIH by further passaging. The Phase 1 study in which 88 vaccination-nanve subjects were vaccinated with ACAM3000 MVA smallpox vaccine was completed in February 2005; there were no serious adverse effects reported, and 97% of the subjects seroconverted after 2 vaccine doses in the highest dose group (1+108 TCID50). No subjects in this study had been previously vaccinated against smallpox, however, and as a large proportion of the population in the US and world-wide has been previously vaccinated against smallpox, it is important to know the safety profile and immunogenicity of the vaccine in this population as well. This Phase II study is therefore designed to confirm the findings of the Phase I trial, further assessing the safety, tolerability, and immunogenicity of ACAM3000 in healthy vaccination-nanve subjects, and to extend the findings in healthy subjects previously vaccinated against smallpox.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。假设：ACAM3000 天花疫苗与传统天花疫苗相比具有非常有利的安全性，并能引起足够的免疫反应，从而有望有效预防天花。改良安卡拉牛痘 (MVA) 是一种牛痘菌株，通过在鸡胚成纤维细胞 (CEF) 中连续传代而减毒，并且在人体中基本上不可复制。因此，人们相信 MVA 疫苗可以提供针对天花的有效保护，而不会产生与具有复制能力的痘苗疫苗相关的反应性和严重副作用。 20 世纪 70 年代，基于 MVA 的疫苗在德国约 120,000 人身上进行了测试，并获得德国国家控制机构许可，可用作预接种疫苗，随后接种传统痘苗疫苗。与德国疫苗同源的ACAM3000 MVA天花疫苗随后在美国NIH进一步传代研制成功。 2005年2月完成了1期研究，其中88名未接种疫苗的受试者接种了ACAM3000 MVA天花疫苗；没有报告严重的不良反应，最高剂量组 (1+108 TCID50) 中 97% 的受试者在接种 2 剂疫苗后出现血清转化。然而，本研究中没有受试者之前接种过天花疫苗，并且由于美国和世界各地很大一部分人口之前接种过天花疫苗，因此了解疫苗的安全性和免疫原性非常重要。这个人口也是如此。 因此，这项 II 期研究旨在证实 I 期试验的结果，进一步评估 ACAM3000 在未接种天花的健康受试者中的安全性、耐受性和免疫原性，并将研究结果扩展到先前接种过天花疫苗的健康受试者中。