Epidemic Parotitis,Mumps Clinical Trial
Official title:
Safety and Efficacy of Attenuated Mumps Vaccine (Human Diploid Cell)
Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland suppurative swelling and pain with fever. The pathological changes and harm caused by mumps was not only confined to the parotid gland, on the contrary, the social harm caused by serious complications cannot be ignored. As mumps is a vaccine-preventable infectious disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13 genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain of MuV in China was the F genotype. The commonly used vaccine strains represented only a small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A strain, which was the first separation and preparation of the attenuated mumps viruses in China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much safer to use. The preliminary test results showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity. The application of this vaccine will provide more effective means to prevent and control of mumps epidemic.
In order to evaluation the safety and immunogenicity of different doses Live Attenuated Mumps Vaccine (Human diploid cell).The study will Determine the optimal dose of vaccine and provide the clinical trail basis for the phase Ⅲ trail design. Primary objective: After single dose immunization of low dose(≥3.0but<3.5lgCCID50)、high dose （≥4.5lgCCID50）Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old.the study will evaluate the standardized positive rate of neutralizing antibody and the GMT of the hemagglutination inhibition antibody and neutralizing antibody,proposing the immune reference dose for phase III clinical trials. Secondary objective： Evaluate the safety of low dose(≥3.0but<3.5lgCCID50)、high dose （≥4.5lgCCID50）Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old. ;