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Development of a novel highly effective influenza vaccine

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI109925-01A1
Agency Tracking Number: R41AI109925
Amount: $600,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA10-124
Timeline
Solicitation Year: 2015
Award Year: 2014
Award Start Date (Proposal Award Date): 2014-06-15
Award End Date (Contract End Date): 2017-05-31
Small Business Information
597 Science Drive, Madison, WI, 53711-1084
DUNS: 827404208
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 PAMUK BILSEL
 (608) 442-6562
 pbilsel@flugen.com
Business Contact
 PAUL RADSPINNER
Phone: (608) 442-6562
Email: pradspinner@flugen.com
Research Institution
 BIOMEDICAL RESEARCH INSTIT/ SOUTHERN, CA
 OCEANSIDE, CA, 92056-3479
 Domestic nonprofit research organization
Abstract
DESCRIPTION provided by applicant Seasonal influenza flu virus an NIAID category C priority pathogen causes widespread infection resulting in at least million cases of severe illness and deaths worldwide Young children and elderly or immunocompromised individuals are typically at greater risk of severe illness or death from influenza Newly emerging strains can result in influenza pandemics with much higher mortality rates even in young healthy adults To address this threat to public health annual universal vaccination is recommended for all individuals aged over months in the US Current vaccines include inactivated trivalent split or subunit and live attenuated vaccine both of which have the drawback that they must be grown using laborious methods in eggs and reformulated every year based on the influenza strains predicted to be prevalent in the next flu season However the major disadvantage of these vaccines is a surprising lack of effectiveness which was highlighted in a recent meta analysis of influenza vaccine live and inactivated in the US Even in the recent season in which the vaccine was well matched to circulating strains only efficacy across the population and a meager efficacy in the elderly was achieved casting doubt on the long standing belief that a close match between the vaccine virus strains and circulating strains results in high effectiveness There is an urgent need for the development of highly effective and cross protective influenza vaccines and new rapid methods of manufacturing To meet this need FluGen has developed a novel vaccine virus M SR based on the deletion of the M gene This deletion in the viral genome allows for single replication of the vaccine virus in the host and production of viral proteins which induces strong cross protective immunity without the generation of progeny virions shedding a goal unmet by current vaccine strategies The M SR is a platform backbone virus that can be modified to encode the viral antigens from any influenza strain and is produced in a novel cell culture system avoiding the use of eggs We hypothesize that M SR will provide safe highly effective broad spectrum long lasting protection against influenza Our preliminary data support this hypothesis and show that the vaccine elicits strong systemic and mucosal immune responses and provides effective cross reactive protection against lethal challenge with influenza We will test this hypothesis in Specific Aims Aim To determine the efficacy of protection afforded by the M SR vaccine We will further investigate the efficacy and longevity of protection against homologous and heterologous viral challenge Aim To determine whether M SR has any pathological effects Lung histology and the inflammatory response will be assessed after vaccination and challenge Aim To determine the mechanism of heterologous protection We will investigate the role of virus specific T and B cell responses in cross protection These studies will provide a comprehensive pre clinical evaluation of the efficacy and safety of the M SR vaccine PUBLIC HEALTH RELEVANCE Seasonal influenza viruses infect of the population resulting in between and deaths and up to hospitalizations per year in the US alone while influenza pandemics can result in as many as million deaths worldwide However current vaccines are only around effective in normal healthy people have very low efficacy in vulnerable populations such as the elderly and provide poor cross reactive protection against newly emerging strains There is an urgent need for a highly effective and safe influenza vaccine which we propose can be met by FluGenandapos s new M SR vaccine

* Information listed above is at the time of submission. *

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