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

NCT ID: NCT01353534

Last Updated: 2012-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-10-31

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)

Conditions

Healthy

Keywords

Immunogenicity and Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

3.8 mcg with AS03 adjuvant at D0 and 21

Group Type: EXPERIMENTAL

A/H5N1 Antigen

Intervention Type: BIOLOGICAL

A/H5N1 Antigen

Group 2

15 mcg at D0 and 21

Group Type: EXPERIMENTAL

A/H5N1 Antigen

Intervention Type: BIOLOGICAL

A/H5N1 Antigen

Group 3

15 mcg + 50 mcg VEP at D0 and 21

Group Type: EXPERIMENTAL

A/H5N1 Antigen

Intervention Type: BIOLOGICAL

A/H5N1 Antigen

Vaccine Enhancement Patch

Intervention Type: DRUG

Vaccine Enhancement Patch

Group 4

30 mcg + 50 mcg VEP at D0

Group Type: EXPERIMENTAL

A/H5N1 Antigen

Intervention Type: BIOLOGICAL

A/H5N1 Antigen

Vaccine Enhancement Patch

Intervention Type: DRUG

Vaccine Enhancement Patch

Interventions

A/H5N1 Antigen

A/H5N1 Antigen

Intervention Type: BIOLOGICAL

Vaccine Enhancement Patch

Vaccine Enhancement Patch

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intercell USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernd Jilma, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Privatklinik Leech

Graz, Graz, Austria

Medizinische Universität Wien

Vienna, Vienna, Austria

Medical University of Vienna

Vienna, , Austria

Antwerp University - Campus Drie Eiken

Antwerp, Antwerp, Belgium

University Hospital Ghent

Ghent, Ghent, Belgium

Countries

Austria; Belgium

Other Identifiers

IC82-102

Identifier Type: -

Identifier Source: org_study_id