IMMUNIZATION OF MACACA FASCICULARIS

这项研究的目的是证实这一假设 灭活疫苗免疫短尾猴的研究 SAF-M佐剂对牙龈卟啉单胞菌的保护作用 对抗实验性牙周炎；监测牙龈下的变化 菌群和检测牙龈假单胞菌抗原特异性抗体 血清、龈沟液(GCF)和唾液中；和测量标志物 GCFs免疫和诱导过程中细胞因子和前列腺素的变化 实验性牙周炎。将对动物进行关于以下方面的调查 一般和口腔健康状况，龈下菌群组成， 和血清中针对牙龈假单胞菌抗原的抗体效价。 使用指定的纳入和排除标准，14只动物将被 注册一组接受免疫，14人进入一组接受免疫 安慰剂疫苗。动物将在基线和3周、6周、 16周时，下颌后牙结扎。在… 在整个研究中的指定时间点，我们将测量炎症， 出血、牙菌斑、口袋深度和附着水平； 牙槽骨测量用标准试牙X线片 通过减影射线照相。在同一时间点，我们将收获 测试牙齿的血液、牙周膜、唾液和龈下菌群。在线状态和 牙龈假单胞菌和其他五种可能的牙周病原体的数量 将在植物群中进行测量。针对P. 血清、唾液和牙周液中的牙周炎将通过酶联免疫吸附试验和 测定血清抗体亲和力。IL-2的存在和数量- 将评估GCF中的β、肿瘤坏死因子-α、前列腺素E_2和血栓素B_2。在第32周， 将从嘴巴随机选择的一侧去除结扎物 大约10/7的活体牙龈假单胞菌被应用于测试牙齿，以及 在第36周重复应用。数据录入和管理将 由数据经理在监督下执行 生物统计学家和调查人员。描述性和分析性 将使用包括重复测量ANOVA在内的统计数据进行评估 由于研究因素，动物内和动物间的可变性。数据 到第32周将与前一项研究的结果合并为 增加统计检验的力量，以确认免疫接种可以 抑制牙槽骨流失，影响菌群。完成这项工作 STUD将确认免疫接种提供保护以及 极大地扩展了我们对系统性、地方性和 黏膜对龈下菌群的免疫反应及其机制 通过它特定的抗体可以减轻骨骼的破坏。

The purposes of this study are to confirm the hypothesis that immunization of Macaca fascicularis with a vaccine containing killed Porphyromonas gingivalis with SAF-M adjuvant can induce protection against experimental periodontitis; to monitor changes in the subgingival flora and to measure antibodies specific for antigens of P. gingivalis in serum, gingival crevicular fluid (GCF), and saliva; and measure marker cytokines and prostaglandins in GCF during immunization and induction of experimental periodontitis. Animals will be surveyed with regard to general and oral health conditions, composition of the subgingival flora, and titers of serum antibodies specific for antigens of P. gingivalis. Using specified inclusion and exclusion criteria, 14 animals will be enrolled in a group to be immunized, and 14 into a group to receive placebo vaccine. Animals will be vaccinated at baseline and weeks 3, 6, and 16, and at week l6 the mandibular posterior teeth ligated. At designated timepoints throughout the study, we will measure inflammation, bleeding, plaque, pocket depth, and attachment level; and take standardized radiographs of test teeth for measurement of alveolar bone by subtraction radiography. At the same timepoints, we will harvest blood, GCF, saliva, and subgingival flora from test teeth. Presence and amounts of P. gingivalis and five other putative periodontal pathogens will be measured in the flora. Antibodies specific for antigens of P. gingivalis in serum, saliva, and GCF will be measured by ELISA and avidity of serum antibodies determined. Presence and amounts of IL- 1beta, TNF-alpha, PGE2, and TxB2 in GCF will be assessed. At week 32, ligatures will be removed from one randomly selected side of the mouth and approximately 10/7 viable P. gingivalis applied to test teeth, and the application repeated at week 36. Data entry and management will be performed by the Data Manager under the supervision of the Biostatistician and the Investigators. Descriptive and analytic statistics will e used including repeated measures ANOVA to evaluate within- and between-animal variability due to study factors. Data through week 32 will be pooled with that of the previous study to increase the power of statistical tests to confirm that immunization can suppress alveolar bone loss and affect the flora. Completion of this stud will confirm that immunization confers protection, as well as greatly extend our knowledge of the effects of systemic, local, and mucosal immune responses on the subgingival flora, and the mechanisms through which specific antibodies attenuate bone destruction.