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3种hCG疫苗(A.β-hCG二聚体、B.β-hCG CT 37肽TT偶合物、C.酶切β-hCG肽段)免疫雌性恒河猴进行毒理学和免疫安全性研究。血液分析结果表明,免疫前后动物血液红细胞数、血红蛋白含量、白细胞数、红细胞沉降速度等血液指标和血清麝香草酚浊度、硫酸锌浊度、黄疸指数等肝功能指标没有显著的差异(P>0.01),免疫后血清谷丙转氨酶虽比免疫前低(P<0.05),但没有临床意义。免疫后血液淋巴细胞水平显著高于免疫前(P<0.01)。组织病理学观察显示除对注射部位肌肉有明显刺激外,3种疫苗免疫对心、肝、肾、睥、胰腺、子宫、卵巢、垂体等器官无特异的组织损伤。免疫荧光分析结果表明抗血清不与猴心、肝、肾、脾、胰腺、子宫、卵巢、垂体和肌肉等组织交叉反应。电镜观察未见疫苗免疫引起肾小球基膜的损害。
Three kinds of hCG vaccines (A.β-hCG dimer, B.β-hCG CT 37 peptide TT conjugate, and C. enzyme-cut β-hCG peptide) were used to immunize female rhesus monkeys for toxicological and immunological safety studies. The results of blood analysis showed that there was no significant difference in hematological parameters such as red blood cell count, hemoglobin content, leukocyte count, and red blood cell sedimentation rate between animals before and after immunization, and liver function indicators such as serum thymol turbidity, zinc sulfate turbidity, and jaundice index. 0.01). Although serum alanine aminotransferase after immunization was lower than before immunization (P<0.05), it had no clinical significance. Blood lymphocyte levels after immunization were significantly higher than before immunization (P<0.01). Histopathological observations showed that except for obvious stimulation of muscles at the injection site, the three vaccines immunized had no specific tissue damage to the heart, liver, kidney, sputum, pancreas, uterus, ovary, pituitary gland, and other organs. Immunofluorescence analysis showed that antiserum did not cross-react with monkey heart, liver, kidney, spleen, pancreas, uterus, ovary, pituitary and muscle. Electron microscopy showed no vaccine immunity caused glomerular basement membrane damage.