Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT01353534
First received: May 12, 2011
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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)


Condition Intervention Phase
Healthy
Biological: A/H5N1 Antigen
Drug: Vaccine Enhancement Patch
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Randomized, Open-Label, Study to Assess the Immunogenicity and Safety of a Vaccine Enhancement Patch (VEP) When Administered With Two Doses of Intramuscular Inactivated Influenza H5N1 Vaccine in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Intercell USA, Inc.:

Primary Outcome Measures:
  • Evaluate hemagglutination inhibition (HI) immune responses [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Comprehensive assessment of solicited and non-solicited local (vaccination site) and systemic adverse events (AEs) Safety follow-up through six months after last vaccination

  • Characterize HI immune responses [ Time Frame: 8 months ] [ Designated as safety issue: No ]

    Characterize HI immune responses in the 15µg A/H5N1 antigen alone group (Group 2) and the 15µg A/H5N1 antigen plus VEP group (Group 3) to determine if levels meet or exceed EMA CPMP/BWP/214/96 criteria for immunogenicity:

    • The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40%
    • The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70%
    • GMT increase > 2.5


Enrollment: 276
Study Start Date: May 2011
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
3.8 mcg with AS03 adjuvant at D0 and 21
Biological: A/H5N1 Antigen
A/H5N1 Antigen
Experimental: Group 2
15 mcg at D0 and 21
Biological: A/H5N1 Antigen
A/H5N1 Antigen
Experimental: Group 3
15 mcg + 50 mcg VEP at D0 and 21
Biological: A/H5N1 Antigen
A/H5N1 Antigen
Drug: Vaccine Enhancement Patch
Vaccine Enhancement Patch
Experimental: Group 4
30 mcg + 50 mcg VEP at D0
Biological: A/H5N1 Antigen
A/H5N1 Antigen
Drug: Vaccine Enhancement Patch
Vaccine Enhancement Patch

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Recent or regular use of oral, topical or injected steroid medications within 30 days prior to vaccination or planned use during the study period.
  • Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination or planned use during the study period
  • Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, and end-stage renal disease, as determined by the Investigator
  • positive serology for HIV-1, HIV-2, HBsAg, or HCV
  • history of severe atopy
  • medical history of acute or chronic skin disease at vaccination area
  • active skin allergy
  • signs of acute skin infection, sunburn or skin abnormalities at the vaccination area including fungal infections, severe acne, active contact dermatitis, or a history of keloid formation
  • hirsute at vaccination area
  • artificial tanning over the duration of the study including the screening period
  • visible tattoos or marks at the vaccination area that would prevent appropriate dermatologic monitoring of the vaccination site
  • fever greater than or equal to 38.0°C at the time of planned vaccination
  • suspicion of or recent history of alcohol or substance abuse
  • women who are pregnant or breastfeeding
  • acute illness at screening or at the time of planned vaccination
  • ever had a serious reaction to prior influenza vaccination
  • developed a neurological disorder following a previous influenza vaccination or have any acute and evolving neurological disorder
  • employee of the investigational site or sponsor
  • history of employment in bird or poultry industries or considerable exposure to birds
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353534

Locations
Austria
Privatklinik Leech
Graz, Austria, 8010
Medical University of Vienna
Vienna, Austria, 1090
Medizinische Universität Wien
Wien, Austria, 1090
Belgium
Antwerp University - Campus Drie Eiken
Antwerp, Belgium, 2610
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
Intercell USA, Inc.
Investigators
Principal Investigator: Bernd Jilma, MD Medizinische Universität Wien
  More Information

No publications provided

Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT01353534     History of Changes
Other Study ID Numbers: IC82-102
Study First Received: May 12, 2011
Last Updated: October 17, 2012
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee

Keywords provided by Intercell USA, Inc.:
Immunogenicity and Safety

ClinicalTrials.gov processed this record on April 17, 2014