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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Intercell USA, Inc.
• Treatments: Vaccines

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