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CompletedNCT00603811Updated Sep 23, 2014

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

A Phase 1 interventional study of VAX102 [Flagellin.HuM2e] and Placebo in Influenza Infection, sponsored by VaxInnate Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-23.

Sponsored by VaxInnate Corporation · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Influenza Infection

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Keywords

  • Influenza vaccines
  • M2e
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 60 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

VaxInnate Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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]

  • Placebo comparator
    2

    Vaccine buffer

    Biological: Placebo

Interventions

  • BiologicalVAX102 [Flagellin.HuM2e]

    dose ranging, 2 i.m. doses given 28 days apart

  • BiologicalPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Safety (local and systemic reactogenicity, laboratory tests and AEs)

    Time frame: 6 months

Secondary outcomes

  1. Immunogenicity after prime and boost (serum IgG to M2e antigen)

    Time frame: 6 months

07

Study locations

2 sites
  • Johnson County Clinical Trials
    Lenexa, Kansas 66219, United States
  • Sealy Vaccine Center, UTMB
    Galveston, Texas 77555, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00603811
Lead sponsor
VaxInnate Corporation
Collaborators
Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
Jan 29, 2008
Start date
Sep 2007
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Sep 23, 2014

Study contacts

Christine Turley, MD
principal investigator · UTMB

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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