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Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults

Influenza Infection Clinical Trial

Official title:
A Multicenter, Double-blind, Randomized, Escalating Dose-ranging Study to Investigate the Safety and Immunogenicity of the VAX102 Influenza Vaccine in Healthy Adults

Clinical Trial Summary

This study will evaluate the safety and immunogenicity of VAX102 [Flagellin.HuM2e], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

Clinical Trial Description

VAX102 is a cross-protective influenza A vaccine based on a recombinant protein expressed in E. coli. The protein comprises Salmonella typhimurium flagellin type 2 (STF2; TLR5 ligand) fused to Human M2e. The active component of the VAX102 vaccine is manufactured by a standard fermentation process. Unlike the HA and NA viral proteins, the amino acid sequence of M2e has remained remarkably stable in all human influenza A virus isolates. Thus an influenza vaccine based on the M2e antigen could elicit cross-protective immunity against most human influenza A virus strains. VAX102 vaccine relies on a single cross-reactive influenza A virus antigen manufactured by a recombinant protein fermentation-production process. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00603811
Study type Interventional
Source VaxInnate Corporation
Contact
Status Completed
Phase Phase 1
Start date September 2007
Completion date October 2008
View Details
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