Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults
This study has been completed.
Sponsor:
VaxInnate Corporation
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT00603811
First received: January 4, 2008
Last updated: June 6, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Infection |
Biological: VAX102 [Flagellin.HuM2e] Biological: Placebo |
Phase 1 |
VaxInnate Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by VaxInnate Corporation:
Primary Outcome Measures:
- Safety (local and systemic reactogenicity, laboratory tests and AEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immunogenicity after prime and boost (serum IgG to M2e antigen) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
VAX102, a recombinant fusion protein that links the influenza A virus M2e antigen to S. typhimurium flagellin, a TLR5 ligand.
|
Biological: VAX102 [Flagellin.HuM2e]
dose ranging, 2 i.m. doses given 28 days apart
|
|
Placebo Comparator: 2
Vaccine buffer
|
Biological: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603811
Locations
| United States, Kansas | |
| Johnson County Clinical Trials | |
| Lenexa, Kansas, United States, 66219 | |
| United States, Texas | |
| Sealy Vaccine Center, UTMB | |
| Galveston, Texas, United States, 77555 | |
Sponsors and Collaborators
VaxInnate Corporation
Bill and Melinda Gates Foundation
Investigators
| Principal Investigator: | Christine Turley, MD | UTMB |
More Information
No publications provided
| Responsible Party: | David N. Taylor, MD, VaxInnate Corporation |
| ClinicalTrials.gov Identifier: | NCT00603811 History of Changes |
| Other Study ID Numbers: | VAX102-01, Gates grant 42462 |
| Study First Received: | January 4, 2008 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by VaxInnate Corporation:
|
Influenza vaccines M2e |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013