麻疹、腮腺炎、风疹三联减毒活疫苗的安全性和免疫原性研究

为了评价国产麻疹、腮腺炎、风疹三联减毒活疫苗(MMR)的安全性和免疫原性,按整体随机抽样原则,以进口同类疫苗和国产各单价疫苗作为对照,开展现场临床观察;比较不同疫苗组免疫后的反应率、抗体阳转率、保护率及几何平均滴度(GMT)。试验组与对照组接种后,除了试验疫苗的中、强发热反应率高于进口对照疫苗的发热反应率(8.60%与2.00%)外,未见其它有显著差异的不良反应。试验组麻疹免后抗体阳转率高于进口对照疫苗(99.5%与94.6%),麻疹抗体GMT也高于单价麻疹对照疫苗的GMT;试验疫苗与进口MMR疫苗的风疹抗体阳转率、腮腺炎抗体阳转率相比,均无显著性差异。实验研究结果显示,试验MMR疫苗与进口MMR疫苗具有相似的临床反应及良好的免疫原性。

Evaluation on the safety and immunogenicity of a new measles-mumps-rubella vaccine(MMR) with a licensed vaccines

To evaluate the safety and immunogenicity of a new measles-mumps-rubella(Hu MMR) vaccine in comparison with licensed MMR(Merck),monovalent measles vaccine,monovalent mumps vaccine and monovalent rubella vaccine.1188 healthy children between 8 and 18 months were enrolled.They were randomized into four groups to receive different vaccines.Except candidate vaccine group had higher fever rates than that of Merck group(8.60% and 2.00%,respectively),the incidences of all other solicited local and general symptoms were comparable between the two groups.Seroconversion rate of measles antibody in trial group was higher than that of Merck MMR vaccine group(99.5% vs 94.6%).GMT of measles antibody in trial group was also higher than that of measles vaccine group.Seroconversion rates of mumps and rubella antibodies had no significant difference between trial group and Merck vaccine group.In conclusion,the new MMR vaccine demonstrated satisfactory immunogenicity and safety profiles as good as the Merck MMR vaccine.