A Study to Evaluate the Safety, Tolerability and Immunogenicity of a Universal Influenza A Vaccine
The purpose of this study is to investigate the safety, tolerability and immunogenicity of ascending doses of a novel, universal flu vaccine, in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability and Immunogenicity of Repeated Intramuscular Administration of an Influenza A Vaccine (FP-01.1)|
- Immunogenicity of FP-01.1. [ Designated as safety issue: No ]Immunogenicity of ascending doses will be assessed
|Study Start Date:||August 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: placebo||Biological: placebo|
Ascending doses of FP-01.1 will be administered
FP-01.1 is composed of a mixture of synthetic peptides, modified with a fluorocarbon vector, which is anticipated to enhance the immune properties of the drug, and allows differentiation from recent investigational interventions by avoiding the use of adjuvant. The peptide sequences, derived from internal influenza-A proteins, were selected based on the presence of CD4+ and CD8+ T cell epitopes and a high degree of conservation across all influenza strains, using a proprietary bioinformatics approach, and, it is proposed, will enable FP-01.1 to universally treat influenza-A -infected populations.
This study is the initial exploration of the safety, tolerability and immunogenicity response of FP-01.1 in healthy volunteers. Ascending doses of FP-01.1 will be assessed.
|Hammersmith Medicines Research Ltd|
|London, United Kingdom|
|Principal Investigator:||Steve Warrington, MD||Hammersmith Medicines Research Ltd|