NCT00921947

Brief Summary

  1. 1.To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
  2. 2.To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.

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 Jun 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

June 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 22, 2011

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

1 month

First QC Date

June 15, 2009

Results QC Date

June 13, 2011

Last Update Submit

August 22, 2011

Conditions

Influenza

Keywords

influenza vaccineM2eUniversal influenza vaccine

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)

    Solicited local and general symptoms experienced within 7 days after vaccination 1.

    0 to 7 days after vaccination

  • Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)

    Solicited local and general symptoms experienced within 14 days after vaccination 2

    14 days after vaccination

Secondary Outcomes (1)

  • Anti-M2e Serum Antibody Concentration

    42 days (+/- 2)

Study Arms (2)

VAX102 IM

EXPERIMENTAL

VAX102 given as 1 µg intramuscular (i.m.)

Biological: VAX102

VAX102 SC

EXPERIMENTAL

VAX102 given as a 2 µg subcutaneous (s.c.) dose

Biological: VAX102

Interventions

VAX102BIOLOGICAL

Universal M2e influenza vaccine

Also known as: STF2.4xM2e
VAX102 IMVAX102 SC

Eligibility Criteria

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

You may qualify if:

  • Adult men or women aged 18 to 49 years inclusive.
  • Able and willing to provide written informed consent to participate.
  • Healthy, as determined by medical history, physical examination, and vital signs.
  • Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
  • Willing to provide multiple blood specimens collected by venipuncture.
  • Females should avoid becoming pregnant during the course of the study
  • Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
  • Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.

You may not qualify if:

  • Persons under 18 years old or 50 years or older.
  • Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
  • Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
  • Persons who have had a prior serious reaction to influenza vaccine.
  • Persons with a history of anaphylactic-type reaction to injected vaccines.
  • Persons with a history of drug or chemical abuse in the year preceding the study.
  • Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
  • Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
  • Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
  • Persons currently participating in another research study involving any study medications (medicines or vaccines).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

VAX102 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. David N.Taylor
Organization
VaxInnate
david.taylor@vaxinnate.com
609-860-2260

Study Officials

  • David N Taylor, MD

    VaxInnate Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

August 24, 2011

Results First Posted

August 22, 2011

Record last verified: 2011-08

Locations

US(1)