SYNTHETIC HEPATITIS B VACCINE STUDIES

本研究的主要目的是提供初步资料， 黑猩猩的安全性，免疫原性和有效性的新的，化学 合成的B型肝炎疫苗。 这些数据是必要的先决条件 未来的人类研究。 为了实现这一目标，将16个氨基酸的HBsAg 合成肽将被环化并配制成明矾吸收的 胶束或与破伤风类毒素共价连接并吸收到明矾上。 这些制剂将被接种到五只黑猩猩身上。 后 在初次接种系列中，动物将用已知的 传染性B型肝炎病毒的数量，以确定免疫力是否 确立了习 第六只动物将作为挑战的对照 接种物。 将对动物进行随访，以获得临床/生化证据 疾病、体液和细胞介导的免疫。

The principal aim of this study is to provide preliminary information in chimpanzees on the safety, immunogenicity and efficacy of a new, chemically synthesized hepatitis B vaccine. These data are a necessary prerequisite to future studies in humans. To accomplish this goal a l6 amino acid HBsAg synthetic peptide will be cyclized and formulated into alum-absorbed micelles or covalently linked to tetanus toxoid and absorbed onto alum. These preparations will be inoculated into five chimpanzees. After a primary series of inoculations, the animals will be challenged with a known quantity of infectious hepatitis B virus to determine whether immunity has been established. A sixth animal will serve as a control for the challenge inoculum. Animals will be followed for evidence of clinical/biochemical disease, humoral and cell-mediated immunity.