NCT01353534

Brief Summary

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site. The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2011

Longer than P75 for phase_1 healthy

Geographic Reach
2 countries

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

May 12, 2011

Last Update Submit

October 17, 2012

Conditions

Healthy

Keywords

Immunogenicity and Safety

Outcome Measures

Primary Outcomes (1)

  • Evaluate hemagglutination inhibition (HI) immune responses

    Evaluate hemagglutination inhibition (HI) immune responses to two doses of 15μg A/H5N1 achieved in the antigen plus VEP group versus the antigen alone group (Group 3 vs. Group 2) at Day 42 using standard serological parameters (Geometric Mean Titer \[GMT\], Geometric Mean Fold Ratio \[GMFR\], seroconversion and seroprotection).

    Day 42

Secondary Outcomes (2)

  • Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP

    8 months

  • Characterize HI immune responses

    8 months

Study Arms (4)

Group 1

EXPERIMENTAL

3.8 mcg with AS03 adjuvant at D0 and 21

Biological: A/H5N1 Antigen

Group 2

EXPERIMENTAL

15 mcg at D0 and 21

Biological: A/H5N1 Antigen

Group 3

EXPERIMENTAL

15 mcg + 50 mcg VEP at D0 and 21

Biological: A/H5N1 AntigenDrug: Vaccine Enhancement Patch

Group 4

EXPERIMENTAL

30 mcg + 50 mcg VEP at D0

Biological: A/H5N1 AntigenDrug: Vaccine Enhancement Patch

Interventions

A/H5N1 AntigenBIOLOGICAL

A/H5N1 Antigen

Group 1Group 2Group 3Group 4
Vaccine Enhancement PatchDRUG

Vaccine Enhancement Patch

Group 3Group 4

Eligibility Criteria

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

You may qualify if:

  • Healthy adult males or females 18-49 years of age (inclusive)
  • signed Informed Consent
  • Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and at all in-clinic visits with understanding to not become pregnant over the duration of the study.

You may not qualify if:

  • Clinically significant laboratory abnormalities at screening
  • abnormalities at physical examination
  • known allergies to any component of the A/H5N1 antigen
  • known egg protein allergy
  • known allergies to adhesives
  • known coagulation disorders
  • use of any anticoagulant medication within 30 days prior to vaccination or planned usage during the study period
  • participated in research involving investigational product within 30 days before planned date of vaccination or planned participation during study period
  • donated or received blood or blood products such as plasma within the three months before planned date of vaccination or planned donation or use during the study period
  • received or planned receipt of seasonal influenza vaccine during the study period
  • received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live vaccines) prior to planned date of vaccination
  • planned receipt of any licensed vaccine during the first 42 days on study
  • previous or planned vaccination with any vaccine containing an oil in water emulsion adjuvant
  • previous or planned vaccination with pandemic vaccine against A/H5N1 or previous proven contact with A/H5N1 wild type virus
  • ever received investigational enterotoxigenic E. coli LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd. Ever received cholera toxin or vaccine
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Privatklinik Leech

Graz, Graz, 8010, Austria

Location

Medizinische Universität Wien

Vienna, Vienna, 1090, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Antwerp University - Campus Drie Eiken

Antwerp, Antwerp, 2610, Belgium

Location

University Hospital Ghent

Ghent, Ghent, 9000, Belgium

Location

Study Officials

  • Bernd Jilma, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 13, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

October 1, 2012

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

BE(2)AU(3)