High antigenicity recoveries after lyophilization in both glass vials and bioneedles

Tetanus toxoid lyophilized in bioneedles showed a 60% recovery when incubated for 3 weeks at 60uC, whereas liquid tetanus toxoid lost all activity after 1 week at 60uC. Whether influenza vaccine in bioneedles follows this same trend can be determined once the influenza vaccine stability can directly be measured from vaccine material in bioneedles. If needed, the lyophilization process for influenza bioneedles can be optimized further to increase vaccine recovery and stability. This study demonstrates the potential of bioneedles as an alternative delivery system for influenza vaccines. The immune responses induced by four influenza vaccine formulations were compared to determine the optimal influenza vaccine for Tubacin bioneedle vaccine development. All influenza vaccine formulations delivered by bioneedles induced immune responses that were noninferior to liquid formulations. WIV was determined as the best influenza vaccine formulation for use in bioneedles, due to its ease of formulation and ability to induce both strong humoral and cellular immune responses. The freeze-dried state of the vaccine in the bioneedle makes it suitable for long-term storage outside the cold chain, and enables easy stockpiling. To continue development, challenge studies with influenza bioneedle vaccine should be performed to confirm the induction of protective immune responses after vaccination. Finally, the potential of bioneedles for influenza vaccine delivery must be confirmed in non-inferiority and/or superiority studies in human. This study confirmed that bioneedles could serve as a promising alternative delivery system for influenza vaccines. Type 1 diabetes mellitus is an autoimmune disease characterized by insufficient insulin secretion and progressive damage of islet b-cells. Currently, its incidence is increasing worldwide in children. T1D is caused by the interactions between genetic predisposition and environmental factors. It has been demonstrated to be a T cell-mediated disease. A current hypothesis is that B-cell also play an immportant role in the development of T1D by regulate T-cells. The balance between Th1 and Th2 cells appears to be vitally important. Hence, a shift of the immune systen from Th1-like immunity to Th2-like immunity may represent an attractice and reasonable therapeutic strategy for T1D. Some studies have been reported that there are some methods were effective in preventing T1D but ineffective in reversing T1D. Th2 cytokines, which could inhibit the function of Th1 cells and activity of Th1 cytokines, are considered as effective therapeutic factors for T1D. IL-10 was first described as cytokine synthesis inhibitory factor. We have previously found that combined with transgenic technology, insulin-secreting cells that overexpress IL10 by in vitro infection of Ad-rIL-10 still have insulin secretion function even at high glucose condition. In addition, IL-10 over-expression can inhibit IL-1b-induced Fas expression and apoptosis of insulin secreting cells, reduce the incidence of diabetes of prediabetic NOD mice, and delay or even prevent T1D development.

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