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

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT00603811
First received: January 4, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Influenza Infection
Biological: VAX102 [Flagellin.HuM2e]
Biological: Placebo
Phase 1

VaxInnate Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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

Resource links provided by NLM:


Further study details as provided by VaxInnate Corporation:

Primary Outcome Measures:
  • Safety (local and systemic reactogenicity, laboratory tests and AEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity after prime and boost (serum IgG to M2e antigen) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
VAX102, a recombinant fusion protein that links the influenza A virus M2e antigen to S. typhimurium flagellin, a TLR5 ligand.
Biological: VAX102 [Flagellin.HuM2e]
dose ranging, 2 i.m. doses given 28 days apart
Placebo Comparator: 2
Vaccine buffer
Biological: Placebo
Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18-49 years inclusive who provide written informed consent to participate.
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Exclusion Criteria:

  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
  • Documented influenza infection in the 6 months prior to study entry.
  • Presently receiving or history of receiving any medications or treatments that affects the immune system
  • Acute disease within 72 hours prior to vaccinations Investigational product (test article) administrations will occur on Days 0 and 28 (± 3).
  • In-clinic safety evaluations will be performed at screening, before each test article dose, and at Days 1, 7 (± 2), 14 (± 2), 29, 35 (± 2), 42 (± 2), 60 (± 2), 120 (± 7), and 180 (± 7).
  • Completion of a Memory Aid for seven days following each vaccine dose will be requested of subjects for use in accurate recall of local and systemic reactions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603811

Locations
United States, Kansas
Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
United States, Texas
Sealy Vaccine Center, UTMB
Galveston, Texas, United States, 77555
Sponsors and Collaborators
VaxInnate Corporation
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Christine Turley, MD UTMB
  More Information

No publications provided

Responsible Party: David N. Taylor, MD, VaxInnate Corporation
ClinicalTrials.gov Identifier: NCT00603811     History of Changes
Other Study ID Numbers: VAX102-01, Gates grant 42462
Study First Received: January 4, 2008
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:
Influenza vaccines
M2e

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014