NCT01353534

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

Completed Phase 1/Phase 2 Last updated 17 October 2012

What this trial tests

Phase 1/Phase 2 trial testing A/H5N1 Antigen in Healthy in 276 participants. Completed in 1 October 2012.

Timeline

1 May 2011

Primary endpoint
1 December 2011

1 October 2012

Quick facts

Lead sponsor	Intercell USA, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	276
Start date	1 May 2011
Primary completion	1 December 2011
Estimated completion	1 October 2012
Sites	5 locations across Austria, Belgium

Drugs / interventions tested

• A/H5N1 Antigen — full drug profile →
• Vaccine Enhancement Patch — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Intercell USA, Inc. — full company profile →

Who can join

Adults 18 to 49, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluate hemagglutination inhibition (HI) immune responses
  Time frame: 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).

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoengineering of vaccines using natural polysaccharides.
   Cordeiro AS, Alonso MJ, de la Fuente M. · · 2015 · cited 70× · PMID 26049133 · DOI 10.1016/j.biotechadv.2015.05.010
2. Alternative vaccine delivery methods
   · 2012