NCT01224262

A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Liquidia Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)	A single vaccination of Fluzone alone
BIOLOGICAL	LIQ001 (0.45mg)	A single vaccination of 0.45 mg LIQ001
BIOLOGICAL	LIQ001 (1.8mg)	A single vaccination of 1.8 mg LIQ001

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-10-20
• Last updated: 2013-03-01

Locations

1 site across 1 country: United States