Influenza Clinical Trial
Official title:
A Randomized, Observer-Blind, Controlled Phase 1/2a Study of the Safety, Tolerability and Immunogenicity of Fluzone Administered With and Without LIQ001 in Two Cohorts of Healthy Subjects: 18-49 Years of Age and 65 Years of Age or Older.
This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65 years of age or older.
Significant advances have been made in the design and delivery of vaccines for the
prevention of influenza over the decades. However, two major hurdles remain in the global
approach to influenza prevention. First, recent epidemiology research has demonstrated that
immune response and protection in elderly populations are suboptimal resulting in
significant seasonal influenza disease in this population every year. Second, while
preparations for the emergence of pandemic influenza strains have progressed, current
egg-based manufacturing methods have not provided sufficient global capacity. Furthermore,
the genesis and scale-up of other manufacturing platforms will not rapidly solve this
problem. Thus, safe and effective ways are needed to improve protection in the elderly as
well as reduce the antigen dose in younger populations in preparation for global needs of
pandemic vaccines.
Historically it is known that presentation of antigens in particulate form, for a wide range
of pathogens, has clear advantages over the presentation of soluble antigen alone. A novel
approach using highly uniform particles has been developed which utilizes size, shape, and
composition to control the delivery and presentation of the vaccine antigen(s) to the immune
system. Production of these highly uniform particles is possible because of a proprietary
manufacturing approach called Pattern Replication in Non-wetting Templates (PRINT®).
The proposed approach is to use the PRINT process to make bioabsorbable particles to improve
the immune response and efficacy of the seasonal influenza vaccine. It is proposed that
mixing properly sized and charged particles with commercial trivalent influenza vaccine
(TIV) will increase vaccine effectiveness and/or decrease the amount of antigen necessary to
induce an immune response.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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