BIODEGRADABLE MINERAL MICROSPHERE ADJUVANTS FOR VACCINES

唯一被批准用于人类的疫苗佐剂是铝胶。 由于铝是一种有毒化合物，即使在低水平下，减少 每剂疫苗所需的剂量将对健康产生广泛的益处。 减少强化所需铝量的可行性 对活动性乙肝表面抗原的免疫应答 乙肝疫苗的成分，已被证明可用于 百得S新型矿物微球。在第二阶段，微球 将对成分进行优化，并将配方冷冻干燥 将制备乙肝表面抗原。这些配方将作为底漆和 小鼠和狒狒体内的强化剂量。 建议的商业应用 矿物微球佐剂不仅可用于肝炎 B疫苗，现在推荐给包括所有人在内的大量人群 青少年和所有卫生工作者，也用于甲型肝炎疫苗和 儿童疫苗接种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 那些是给艾滋病人的。制备冻干疫苗剂型的潜力 不需要冷藏就能产生额外的商业价值 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.