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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
152
A single vaccination of Fluzone alone
A single vaccination of 0.45 mg LIQ001
A single vaccination of 1.8 mg LIQ001
Accelovance - Melbourne
Melbourne, Florida, United States
The rate of Adverse Events attributable to each of the doses of LIQ001 mixed with Fluzone compared to Fluzone alone.
Time frame: 35 days post-vaccination
HAI response (Geometric Mean Titer) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Time frame: 21 days post-vaccination
HAI response (Percent with HAI titer greater than or equal to 1:40) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Time frame: 21 days post-vaccination
HAI response (Seroconversion rate) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
Time frame: 21 days post-vaccination
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