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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00603811
Other study ID # VAX102-01
Secondary ID Gates grant 4246
Status Completed
Phase Phase 1
First received January 4, 2008
Last updated September 22, 2014
Start date September 2007
Est. completion date October 2008

Study information

Verified date September 2014
Source VaxInnate Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 49 Years
Eligibility 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.

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


Intervention

Biological:
VAX102 [Flagellin.HuM2e]
dose ranging, 2 i.m. doses given 28 days apart
Placebo
Placebo

Locations

Country Name City State
United States Sealy Vaccine Center, UTMB Galveston Texas
United States Johnson County Clinical Trials Lenexa Kansas

Sponsors (2)

Lead Sponsor Collaborator
VaxInnate Corporation Bill and Melinda Gates Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety (local and systemic reactogenicity, laboratory tests and AEs) 6 months Yes
Secondary Immunogenicity after prime and boost (serum IgG to M2e antigen) 6 months No
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