Influenza Clinical Trial
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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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