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

临床试验：未佐剂诺华 H1N1 流感疫苗 I 的 II 期研究

• 批准号: 8167206
• 负责人: WILLIAM GERALD TEAGUE
• 金额: $ 18.58万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167206
• 关键词: Antibody Formation; Asthma; Breathing; Clinical Data; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Development; Dose; Funding; Grant; H1N1 vaccine; Immune response; Immunity; Individual; Influenza; Influenza A Virus, H1N1 Subtype; Influenza A virus; Influenza vaccination; Institution; Oral; Patients; Phase; Protocols documentation; Research; Research Personnel; Resources; Safety; Source; Testing; Time; United States National Institutes of Health; Vaccination; Vaccines; base; immunogenicity; influenza virus vaccine; novel; response

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 需要获得关于哮喘患者接种H1N1流感疫苗的安全性和免疫原性的早期信息，特别是那些接受高剂量吸入性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，可能需要更高剂量或多次剂量的无佐剂灭活H1N1流感疫苗，以向最大数量的疫苗接种者提供保护。新型无佐剂灭活H1N1流感疫苗在轻度/中度或重度哮喘患者中引发最佳应答的能力尚不清楚。本方案将探索两种不同剂量水平（15 mcg和30 mcg）疫苗接种后的抗体应答。每个剂量水平的灭活H1N1流感疫苗需要两次接种，间隔21天。 本研究还将评估单剂疫苗接种后的免疫反应，以测试个体是否具有任何预先存在的初次免疫力，以便初始H1N1疫苗接种可以作为加强免疫，从而在需要更少剂量的情况下更快地获得保护。将在每次疫苗接种后8天评估抗体应答，以评价既往应答的发展。此外，将在每次给药后21天评估抗体应答。 本研究将使用Novartis的2009年H1N1无佐剂灭活甲型H1N1流感疫苗。