VaxiPatch (TM), a novel vaccination system comprised of subunit antigens, adjuvants and microneedle skin delivery: An application to influenza B/Colorado/06/2017
VACCINE
Authors: Ellison, Thomas J.; Talbott, George C.; Henderson, Daniel R.
Abstract
This work introduces VaxiPatch, a novel vaccination system comprised of subunit glycoprotein vaccine antigens, adjuvants and dermal delivery. For this study, rHA of influenza virus B/Colorado/06/2017 was incorporated into synthetic virosomes, and adjuvant liposomes were formed with QS-21 from Saponaria quillaja, with or without the synthetic TLR4 agonist 3D - (6-acyl) PHAD. These components were concentrated and co-formulated into trehalose with dye. Dermal delivery was achieved using an economical 37-point stainless steel microneedle array, designed for automated fill/finish by microfluidic dispensers used for mass production of immunodiagnostics. Vaccine and adjuvant are deposited to form a sugar glass in a pocket on the side of each of the tips, allowing skin penetration to be performed directly by the rigid steel structure. In this study, Sprague Dawley rats (n = 6 per group) were vaccinated by VaxiPatches containing 0.3 mu g of rHA, 0.5 mu g QS-21 and 0.2 mu g 3D - (6-acyl) PHAD and dye, resulting in antigen-specific IgG titers 100-fold higher than 4.5 mu g of FluBlok (p = 0.001) delivered intramuscularly. Similarly, hemagglutination inhibition titers in these animals were 14-fold higher than FluBlok controls (p = 0.01). Non-adjuvanted VaxiPatches were also compared with rHA virosomes injected intramuscularly. Accelerated shelf life studies further suggest that formulated virosomal antigens retain activity for at least two months at 60 degrees C. Further, co-formulation of a dye could provide a visible verification of delivery based on the temporary pattern on the skin. A room-temperature-stable vaccination kit such as VaxiPatch has the potential to increase vaccine use and compliance globally. (C) 2020 The Author(s). Published by Elsevier Ltd.
Serum IgG2 levels predict long-term protection following pneumococcal vaccination in systemic lupus erythematosus (SLE)
VACCINE
Authors: Gerard, Anne-Laure; Goulenok, Tiphaine; Bahuaud, Mathilde; Francois, Chrystelle; Aucouturier, Pierre; Moins-Teisserenc, Helene; Batteux, Frederic; Papo, Thomas; Sacre, Karim
Abstract
Systemic lupus erythematosus (SLE) patients are at risk for pneumococcal infection. Twenty-one consecutive SLE patients (40[25-75] years) received the sequential PCV13/PPSV23 vaccine and factors associated with long-term protection were analyzed. Immune protection, defined by an antigen-specific IgG concentration >= 1.3 mu g/mL for at least 70% of 7 pneumococcal serotypes was assessed at baseline, 2, 6, 12 and 36 months defining long-term protection. Only 10 patients showed pneumococcal immune protection 36 months after vaccination. Eleven (52.4%) patients had no long-term protection with a seroconversion that never or only transiently occurred. SLE disease features, treatment received and immunological characteristics did not differ between protected and unprotected patients except for the pre-vaccination IgG2 serum levels. Serum IgG2 level >2.125 mu g/ml showed a sensitivity of 100% and a specificity of 90.9% for long-term protection. Sequential pneumococcal vaccination conferred poor immune protection in SLE. Baseline IgG2 serum level identified patients able to benefit from pneumococcal vaccination. (c) 2020 Elsevier Ltd. All rights reserved.