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| ID | Type | Description | Link |
|---|---|---|---|
| Gates grant 42462 |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | VAX102, a recombinant fusion protein that links the influenza A virus M2e antigen to S. typhimurium flagellin, a TLR5 ligand. |
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| 2 | Placebo Comparator | Vaccine buffer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAX102 [Flagellin.HuM2e] | Biological | dose ranging, 2 i.m. doses given 28 days apart |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety (local and systemic reactogenicity, laboratory tests and AEs) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity after prime and boost (serum IgG to M2e antigen) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Turley, MD | UTMB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States | ||
| Sealy Vaccine Center, UTMB |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo |
| Biological |
Placebo |
|
| Galveston |
| Texas |
| 77555 |
| United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |