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资助的中心赠款提供的资源的许多研究子项目之一。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。列出的机构适用于该中心，这不一定是调查员的机构。假设：与传统的天花疫苗相比，ACAM3000天花疫苗具有高度有利的安全性，并引起足够的免疫反应，可以预期它将有效防止天花。修改后的Ankara（MVA）是一种疫苗菌株，已因雏鸡胚胎成纤维细胞（CEF）的系列通过而减弱，并且在人类中基本上没有复制。因此，据信，MVA疫苗可以提供有效的天花保护，而没有反应性和严重的副作用，与复制能力的疫苗疫苗有关。 1970年代，在德国约有12万人对基于MVA的疫苗进行了测试，并获得了德国国家控制权管理局的许可，以用作疫苗接种，随后是传统的疫苗疫苗。随后通过进一步传播在美国在美国开发了与德国疫苗具有共同起源的ACAM3000 MVA天花疫苗，该疫苗与德国疫苗具有共同的起源。 2005年2月，完成了88名疫苗接种受试者接种ACAM3000 MVA天花疫苗的1阶段研究；没有严重的不良反应报道，在最高剂量组中2次疫苗剂量后，有97％的受试者（1+108 TCID50）在血清转化。然而，这项研究中没有对天花接种疫苗，并且由于在美国和全球范围内的很大一部分人口已经接种了天花，因此也重要的是要了解该疫苗在该人群中的安全性和免疫原性。 因此，这项II期研究旨在确认I期试验的发现，进一步评估ACAM3000在健康疫苗接种中的ACAM3000的安全性，耐受性和免疫原性，并扩展了先前针对天花接种疫苗的健康受试者的发现。