Healthy
Conditions
Keywords
Immunogenicity and Safety
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)
Interventions
BIOLOGICALA/H5N1 Antigen
A/H5N1 Antigen
DRUGVaccine Enhancement Patch
Vaccine Enhancement Patch
Sponsors
Intercell USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate hemagglutination inhibition (HI) immune responses | Day 42 | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP | 8 months | 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 | 8 months | 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 |
Countries
Austria, Belgium
Outcome results
None listed