NCT00603811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 23, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

January 4, 2008

Last Update Submit

September 22, 2014

Conditions

Influenza Infection

Keywords

Influenza vaccinesM2e

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

1

EXPERIMENTAL

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

Biological: VAX102 [Flagellin.HuM2e]

2

PLACEBO COMPARATOR

Vaccine buffer

Biological: Placebo

Interventions

VAX102 [Flagellin.HuM2e]BIOLOGICAL

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

1
PlaceboBIOLOGICAL

Placebo

2

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johnson County Clinical Trials

Lenexa, Kansas, 66219, United States

Location

Sealy Vaccine Center, UTMB

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Christine Turley, MD

    UTMB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 29, 2008

Study Start

September 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 23, 2014

Record last verified: 2014-09

Locations

US(2)