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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Double-blind, Randomized, Escalating Dose-ranging Study to Investigate the Safety and Immunogenicity of the VAX102 Influenza Vaccine in Healthy Adults

Conditions
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Influenza Infection

Intervention / Treatment
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* Biological: VAX102 [Flagellin.HuM2e]
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>VAX102, a recombinant fusion protein that links the influenza A virus M2e antigen to S. typhimurium flagellin, a TLR5 ligand. | Biological: VAX102 [Flagellin.HuM2e]<br>* dose ranging, 2 i.m. doses given 28 days apart<br>|
| Placebo Comparator: 2<br>Vaccine buffer | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (local and systemic reactogenicity, laboratory tests and AEs) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity after prime and boost (serum IgG to M2e antigen) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccines, M2e