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Report for Clinical Trial NCT01353534

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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)

NCT01353534 Healthy
MeSH:Influen Influenza in Birds

2 Interventions

Name: A/H5N1 Antigen

Description: A/H5N1 Antigen
Type: Biological
Group Labels: 4

Group 1 Group 2 Group 3 Group 4

Name: Vaccine Enhancement Patch

Description: Vaccine Enhancement Patch
Type: Drug
Group Labels: 2

Group 3 Group 4

Primary Outcomes

Description: 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).

Measure: Evaluate hemagglutination inhibition (HI) immune responses

Time: Day 42

Secondary Outcomes

Description: Comprehensive assessment of solicited and non-solicited local (vaccination site) and systemic adverse events (AEs) Safety follow-up through six months after last vaccination

Measure: Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP

Time: 8 months

Description: 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

Measure: Characterize HI immune responses

Time: 8 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 R192G

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. --- R192G ---

HPO Nodes