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

Phase 1

Completed

• Conditions: Influenza Infection
• Interventions: Biological: Placebo; Biological: VAX102 [Flagellin.HuM2e]

• Registration Number: NCT00603811
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-22
• Last Update Posted: 2014-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Vaccine buffer
1	VAX102 [Flagellin.HuM2e]	VAX102, a recombinant fusion protein that links the influenza A virus M2e antigen to S. typhimurium flagellin, a TLR5 ligand.

Primary Outcome Measures

Name	Time	Method
Safety (local and systemic reactogenicity, laboratory tests and AEs)	6 months

Secondary Outcome Measures

Name	Time	Method
Immunogenicity after prime and boost (serum IgG to M2e antigen)	6 months

Trial Locations

Locations (2)

Johnson County Clinical Trials; 🇺🇸 Lenexa, Kansas, United States

Sealy Vaccine Center, UTMB; 🇺🇸 Galveston, Texas, United States