André F E, Peetermans J
Dev Biol Stand. 1986;65:101-7.
During the course of clinical studies to develop a new bivalent measles-mumps vaccine, it was established that simultaneous administration of live measles and mumps vaccines at doses contained in the monovalent vaccines resulted in a reduced seroconversion rate against mumps but not against measles. This one-way interference was resolved by increasing the dose of the mumps component in the bivalent measles-mumps and the trivalent measles-mumps-rubella vaccines above that in the monovalent mumps vaccine. On the other hand, it was not necessary to adjust the doses of the measles and rubella components in the combined vaccines. This observation requires that not only the titres of vaccine viruses must be carefully adjusted in combined live mumps vaccines but also that the heat-stability of each component in such vaccines be carefully determined to ensure that interference is not a problem during the complete shelf-life of the product. The relative doses at release of combined mumps vaccines using the Urabe Am 9 strain and the heat-stability characteristics of these products will be presented and discussed.
在研发一种新的二价麻疹-腮腺炎疫苗的临床研究过程中,已确定以单价疫苗中的剂量同时接种活麻疹疫苗和腮腺炎疫苗时,腮腺炎的血清转化率降低,但麻疹的血清转化率未受影响。通过提高二价麻疹-腮腺炎疫苗和三价麻疹-腮腺炎-风疹疫苗中腮腺炎成分的剂量,使其高于单价腮腺炎疫苗中的剂量,解决了这种单向干扰问题。另一方面,无需调整联合疫苗中麻疹和风疹成分的剂量。这一观察结果表明,不仅在联合活腮腺炎疫苗中必须仔细调整疫苗病毒的滴度,而且还必须仔细确定此类疫苗中各成分的热稳定性,以确保在产品的整个保质期内不会出现干扰问题。将介绍并讨论使用Urabe Am 9株的联合腮腺炎疫苗放行时的相对剂量及其产品的热稳定性特征。