CLINICAL TRIAL: PHASE II STUDY OF UNADJUVANTED NOVARTIS H1N1 INFLUENZA VACCINE I

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 有必要提供有关哮喘患者接种H1N1流感疫苗的安全性和免疫原性的早期信息，特别是那些吸入大剂量糖皮质激素和口服糖皮质激素的患者， 根据其他新型甲型流感病毒的临床数据，为了保护最大数量的疫苗接受者，可能需要更高剂量或更多剂量的未经佐剂的灭活流感H1N1疫苗。一种新的无佐剂、灭活的H1N1流感疫苗在轻度/中度或重度哮喘患者中诱导最佳反应的能力尚不清楚。该方案将探索在两个不同剂量水平(15微克和30微克)接种疫苗后的抗体反应。每种剂量水平的甲型H1N1流感灭活疫苗将需要两次接种，间隔21天。 这项研究还将评估单剂疫苗接种后的免疫反应，以测试个人是否具有任何先前存在的主要免疫力，以便最初接种H1N1疫苗起到促进作用，从而在需要较少剂量的情况下提供更快的保护时间。抗体反应将在每次接种疫苗后8天进行评估，以评估记忆反应的发展。此外，将在每次注射后21天评估抗体反应。 这项研究将使用诺华公司2009年H1N1未加佐剂的甲型H1N1流感灭活疫苗。

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. There is a need for early information on the safety and immunogenicity of H1N1 influenza vaccination on patients with asthma, especially those on high doses of inhaled glucocorticosteroids and oral glucocorticosteroids, Based on clinical data from other novel influenza A viruses, a higher dose, or multiple doses of an unadjuvanted, inactivated influenza H1N1 vaccine may be necessary to confer protection to a maximal number of vaccine recipients. The capacity of a novel unadjuvanted, inactivated influenza H1N1 vaccine to elicit an optimal response in patients with mild/moderate, or severe asthma is not known. This protocol will explore the antibody response following vaccination at two different dose levels (15 mcg and 30 mcg). Each dose level of inactivated influenza H1N1 vaccine will require two administrations that will be given 21 days apart. This study will also assess the immune response following a single dose of vaccine, to test whether individuals have any pre-existing prime immunity, such that the initial H1N1 vaccination serves as a boost, thus conferring a more rapid time to protection with the need for fewer doses. Antibody responses will be assessed at 8 days after each vaccine administration to evaluate the development of an anamnestic response. In addition, antibody responses will be assessed at 21 days after each dose. This study will utilize the H1N1 unadjuvanted inactivated Influenza A (H1N1) 2009 vaccine from Novartis.