BIODEGRADABLE MINERAL MICROSPHERE ADJUVANTS FOR VACCINES

唯一被批准用于人类的疫苗佐剂是铝凝胶。 由于铝是一种有毒化合物，即使在低水平下， 每剂疫苗所需的量将具有广泛的健康益处。 研究了降低强化所需铝量的可行性， 对B型肝炎表面抗原（HBsAg）的免疫应答， B型肝炎疫苗的组成部分，已被证明利用 BIOTEK的新型矿物微球。 在第二阶段，微球 组合物将被优化，并且制剂冻干结合 将制备HBsAg。 这些制剂将作为底漆进行研究， 小鼠和狒狒的加强剂量。 建议的商业应用 矿物微球佐剂不仅可用于肝炎， B类疫苗，现在推荐用于大规模人群， 青少年和所有卫生工作者，但也为甲型肝炎疫苗， 儿童疫苗系列的许多组成部分。 这样更安全 佐剂也可用于正在开发的疫苗，包括 那些艾滋病。 制备冻干疫苗剂量的潜力 不需要冷藏就能增加商业价值 用于矿物微球佐剂。

The only vaccine adjuvants approved for use in humans are aluminum gels. As aluminum is a toxic compound, even at low levels, reductions in the amount needed for each vaccine dose will be of broad health benefit. The feasability of reducing the amount of aluminum needed to potentiate the immune response to hepatitis B surface antigen (HBsAg), the active constituent of hepatitis B vaccines, has been demonstrated utilizing BIOTEK s novel mineral microspheres. In Phase II the microsphere composition will be optimized and formulations lyophilized with bound HBsAg will be prepared. The formulations will be studies as primer and booster doses in mice and baboons. PROPOSED COMMERCIAL APPLICATION The mineral microsphere adjuvant could be utilized not only in hepatitis B vaccines, now recommended for a large population including all adolescents and all health workers, but also for hepatitis A vaccine and for many components of the childhood vaccination series. This safer adjuvant could also be employed in vaccines under development, including those for AIDS. The potential for preparing lyophilized vaccine doses which would not require refrigeration generates added commercial value for the mineral microsphere adjuvants.