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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603811
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : September 23, 2014
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
VaxInnate Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Infection Biological: VAX102 [Flagellin.HuM2e] Biological: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety (local and systemic reactogenicity, laboratory tests and AEs) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Immunogenicity after prime and boost (serum IgG to M2e antigen) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603811

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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
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Principal Investigator: Christine Turley, MD UTMB
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Responsible Party: VaxInnate Corporation Identifier: NCT00603811    
Other Study ID Numbers: VAX102-01
Gates grant 42462
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: September 23, 2014
Last Verified: September 2014
Keywords provided by VaxInnate Corporation:
Influenza vaccines
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases