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


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

Improved Immune Responses in The Elderly

Figure 4. Seroconversion rates of patients in a human clinical trial testing IS patch performance in elderly. Young adults had 69%, 56%, and 61% seroconversion rates for A/New Caledonia, A/Panama and B/Shandong respectively. These rates were significantly higher or showed a trend compared to corresponding seroconversion rates in the elderly without a patch (40% [p=0.005], 36% [p=0.06], and 38% [p=0.03], respectively). The addition of an IS patch to the elderly improved these seroconversion rates to 63%, 54%, and 50% respectively, reaching significance in the A/New Caledonia strain (p=0.01) and a trend for A/Panama (p=0.08). The seroconversion rates in elderly receiving the patch were not significantly different from those in healthy adults, and represent an absolute improvement of 23% (A/New Caledonia), 18% (A/Panama) and 12% (B/Shandong) in seroconversion of the elderly over those not receiving the patch.
An LT-IS patch was also tested in humans vaccinated with a commercial influenza vaccine.15 In this clinical study, three groups of approximately 55 volunteers were vaccinated with a standard injected flu vaccine consisting of A/New Caledonia, A/Panama, and B/Shangdong. The first group consisted of healthy young adults; the second and third groups consisted of elderly adults over 65 years of age. In the third group, the elderly subjects were vaccinated with the flu vaccine in combination with the LT-IS patch (50 μg LT). Three weeks following the vaccination, the hemagglutination inhibition (HAI) responses were measured. Figure 4 shows the percentage of seroconversion based on a four-fold rise in HAI titers. The percent change in seroconversion was highest for the healthy young adults (first group), followed by the elderly group (third group) receiving the LT-IS patch. Overall, the LT-IS patch improved the elderly seroconversion rates by 23%, 18%, and 12% percentage points for A/New Caledonia, A/Panama, and B/Shangdong, respectively, as compared to the second group which received the vaccination alone. This study shows that an LT-IS patch applied onto the skin after an IM injection can augment the immune response, as predicted from animal models.

Wet Versus Dry Patch Formulations

The preclinical and Phase 1 studies used the LT-IS patch in a wet patch format. A dry patch offers advantages over a wet patch in terms of ease of use in a clinical setting (i.e., fewer manipulative steps required for administration), commercial viability (i.e., production, packaging, and distribution), and stability (i.e., dry product is expected to be more stable than liquid product due to removal of bulk water). Recently, we developed a stable formulation matrix and process technology to compound adjuvants, as well as vaccine antigens of interest, into a dry patch format. Using this formulation platform technology, we have prepared a dry formulated LT patch and have conducted a clinical trial to compare the effect of a wet versus dry LT patch on skin delivery.

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