The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional Vaccines - Preclinical and clinical trials have demonstrated proof-of-concept for the LT-IS patch. - BioPharm

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The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional Vaccines
Preclinical and clinical trials have demonstrated proof-of-concept for the LT-IS patch.


BioPharm International


We also present real-time stability data showing that the dry LT-IS patch is stable at 2–8 C for at least 22 months. Based on accelerated and thermal cycling stress data, the dry LT-IS patch has an adequate thermostability profile to allow storage and use at room temperature and to withstand extreme temperatures during shipment and distribution.

A pilot-scale manufacturing operation has been custom-built specifically for making LT and other vaccine-based patches. Scale-up work is currently under way to produce and stockpile 150 million LT-IS patches.

Preclinical and Clinical Studies

Dose Sparing for Bird Flu Vaccine Candidate


Figure 1. Dose sparing in the mouse model using rH5 (Anti-A/Vietnam/1203/2004). Mice received two intradermal immunizations 14 days apart of 0.015, 0.15, or 1.5 μg rHA and IS patches containing either 10 μg LT or a placebo with no LT. Serum IgG titers were determined by an ELISA method. Results of individual animals (open circles) and the group geomeans (bars) are shown. Groups receiving LT have statistically greater titers than groups receiving placebo patches.
In a mouse study, the LT-IS patch provided up to 100-fold dose sparing for a pandemic flu vaccine candidate (Figure 1). For this study, three groups of mice were immunized intradermally (ID) with a recombinant hemagglutinin (rHA) protein representing the A/Vietnam/1203/2004 (H5N1) strain at 1.5 μg, 0.15 μg, and 0.015 μg. Half of each group had an LT-IS patch (containing 10 μg LT) placed over the injection site and the other half received a placebo (no LT) patch. Following a two-dose regimen at Day 0 and Day 14, the rHA immune responses were determined two weeks after the second dose. As indicated in Figure 1, the group receiving the 0.015 μg dose with the LT-IS patch had an antibody response (47,491 ELISA units) comparable to the group receiving the 1.5 μg dose ID alone (20,142). This data suggests that a 100-fold reduction in vaccine may be achieved when the vaccine is delivered intradermally with the LT-IS patch. Data collected in the same study suggests that a 10-fold reduction in vaccine can be achieved when the vaccine is delivered by intramuscular injection (IM) (data not shown).


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