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

Sponsors and Collaborators:	VaxInnate Corporation Bill and Melinda Gates Foundation
Information provided by:	VaxInnate Corporation
ClinicalTrials.gov Identifier:	NCT00603811

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 I

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator 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

Responsible Party:	VaxInnate Corporation ( David N. Taylor, MD )
Study ID Numbers:	VAX102-01, Gates grant 42462
Study First Received:	January 4, 2008
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00603811
Health Authority:	United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:

Influenza vaccines
M2e

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009