Clinical trial NCT01353534: Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Immunogenicity and Safety
Lead sponsor: Intercell USA, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Evaluate hemagglutination inhibition (HI) immune responses
timeFrame: Day 42
Secondary outcomes:
measure: Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP
timeFrame: 8 months
measure: Characterize HI immune responses
timeFrame: 8 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Privatklinik Leech
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Antwerp
country: Belgium
facility: Antwerp University - Campus Drie Eiken
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: Medical University of Vienna
name: Bernd Jilma, MD
role: PRINCIPAL_INVESTIGATOR
References: