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

Influenza Infection Clinical Trial

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

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

• Influenza Infection
• Influenza, Human

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