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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014