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

Primary Purpose

Influenza Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VAX102 [Flagellin.HuM2e]

Placebo

About this trial

This is an interventional prevention trial for Influenza Infection focused on measuring Influenza vaccines, M2e

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Johnson County Clinical Trials
Sealy Vaccine Center, UTMB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

VAX102, a recombinant fusion protein that links the influenza A virus M2e antigen to S. typhimurium flagellin, a TLR5 ligand.

Vaccine buffer

Outcomes

Primary Outcome Measures

Safety (local and systemic reactogenicity, laboratory tests and AEs)

Secondary Outcome Measures

Immunogenicity after prime and boost (serum IgG to M2e antigen)

Full Information

NCT ID

NCT00603811

First Posted

January 4, 2008

Last Updated

September 22, 2014

Sponsor

VaxInnate Corporation

Collaborators

Bill and Melinda Gates Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00603811

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VaxInnate Corporation

Collaborators

Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Infection

Keywords

Influenza vaccines, M2e

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

VAX102, a recombinant fusion protein that links the influenza A virus M2e antigen to S. typhimurium flagellin, a TLR5 ligand.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Vaccine buffer

Intervention Type

Biological

Intervention Name(s)

VAX102 [Flagellin.HuM2e]

Intervention Description

dose ranging, 2 i.m. doses given 28 days apart

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Safety (local and systemic reactogenicity, laboratory tests and AEs)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Immunogenicity after prime and boost (serum IgG to M2e antigen)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Turley, MD

Organizational Affiliation

UTMB

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johnson County Clinical Trials

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

Facility Name

Sealy Vaccine Center, UTMB

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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