Srinivasa Reddy Y, Narendra Babu K, Uday Kumar P, Qadri S S Y H, Surekha M V, Dinesh Kumar B
Advanced Centre for Preclinical Toxicology Studies, ICMR-National Institute of Nutrition, Jamai-Osmania, Hyderabad 500007, India.
Department of Microbiology and Immunology, ICMR-National Institute of Nutrition, Jamai-Osmania, Hyderabad 500007, India.
Data Brief. 2021 May 8;36:107100. doi: 10.1016/j.dib.2021.107100. eCollection 2021 Jun.
Current article illustrates the data of body weight, biochemical, haematological profile, and organ weights of rats and rabbits administered with recombinant human papilloma virus (HPV) vaccine, along with genotoxicity effect. The data was collected from nonclinical safety/toxicity and immune response evaluations of recombinant expressing the HPV 16 and 18 L1 proteins as vaccine. The intended clinical route of vaccine administration is through oral route, whereas it is established fact that attenuated i could not colonize in laboratory animals. In view of this it is challenging to undertake the nonclinical safety/toxicity evaluations following the regulatory guidelines. Hence sub chronic safety/toxicity testing was carried out in rat and rabbits by administration of HPV vaccine through oral (intended clinical route) and innovative intranasal routes. The prophylactic dose derived from adult human clinical dose (2 × 10CFU/70 kg) was administered to SD rats (PD: 0.18 × 10CFU/kg) and New Zealand White (NZW) rabbits (PD: 0.09 × 10CFU/kg) through oral and intranasal routes. Similarly, average dose (AD:5xPD) was administered to rats (AD:0.9 × 10CFU/kg) and rabbits (AD: 0.45 × 10CFU/kg) through intranasal route only. The repeated doses were administered on 3rd and 5th days of post-exposure of 1st dose through specified routes and test compound effects in relation with time of exposure was assessed by euthanizing animals and data collection at different time points i.e. 15th (25% of animals), 29th (25% of animals) and 93rd days (50% of animals) of post-exposure of 1st dose. The retro-orbital plexus blood was collected before euthanizing animals to unveil the biochemical and haematological profile. The data on genotoxicity effect of test compound, if any, was obtained by assessing the bone-marrow micronucleus assay. The immune response and allergenicity in terms of specific IgG and IgE levels against HPV 16 and 18 L1 proteins were determined in mice. The raw data of various parameters collected at different time points were compiled and computed according to the groups. The haematological profile and organ weights data can be used as reference data for SD rats and NZW rabbits for future studies.
当前文章阐述了给大鼠和兔子施用重组人乳头瘤病毒（HPV）疫苗后的体重、生化指标、血液学指标及器官重量数据，以及遗传毒性效应。这些数据来自对表达HPV 16和18 L1蛋白作为疫苗的重组体进行的非临床安全性/毒性及免疫反应评估。疫苗预期的临床给药途径是口服，然而事实是减毒疫苗无法在实验动物中定殖。鉴于此，按照监管指南进行非临床安全性/毒性评估具有挑战性。因此，通过口服（预期临床途径）和创新的鼻内途径给大鼠和兔子施用HPV疫苗，进行了亚慢性安全性/毒性试验。将源自成人临床剂量（2×10CFU/70kg）的预防剂量通过口服和鼻内途径施用于SD大鼠（PD：0.18×10CFU/kg）和新西兰白兔（NZW）（PD：0.09×10CFU/kg）。同样，仅通过鼻内途径将平均剂量（AD：5×PD）施用于大鼠（AD：0.9×10CFU/kg）和兔子（AD：0.45×10CFU/kg）。在首次给药暴露后的第3天和第5天，通过指定途径重复给药，并通过对动物实施安乐死并在不同时间点（即首次给药暴露后的第15天（25%的动物）、第29天（25%的动物）和第93天（50%的动物））收集数据，评估测试化合物与暴露时间相关的效应。在对动物实施安乐死之前，采集眶后丛血液以揭示生化和血液学指标。通过评估骨髓微核试验，获取测试化合物的遗传毒性效应数据（如有）。在小鼠中测定针对HPV 16和18 L1蛋白的特异性IgG和IgE水平方面的免疫反应和致敏性。对在不同时间点收集的各种参数的原始数据进行整理并按组计算。血液学指标和器官重量数据可作为SD大鼠和NZW兔子未来研究的参考数据。
