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

University Of Virginia, Charlottesville VA

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Abstract

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.