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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
A/H5N1 Antigen
Vaccine Enhancement Patch
Privatklinik Leech
Graz, Graz, Austria
Medizinische Universität Wien
Vienna, State of Vienna, Austria
Medical University of Vienna
Vienna, Austria
Antwerp University - Campus Drie Eiken
Antwerp, Antwerp, Belgium
University Hospital Ghent
Ghent, Ghent, Belgium
Evaluate hemagglutination inhibition (HI) immune responses
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).
Time frame: Day 42
Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP
Comprehensive assessment of solicited and non-solicited local (vaccination site) and systemic adverse events (AEs) Safety follow-up through six months after last vaccination
Time frame: 8 months
Characterize HI immune responses
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
Time frame: 8 months
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