Clinical Trial: Phase II of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of Attenuated Mumps Vaccine (Human Diploid Cell)

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Chinese Academy of Medical Sciences

Current Primary Outcome:

  • Positive conversion rate of Muv hemagglutination inhibition antibody of different single dose of Muv Vaccine [ Time Frame: the 0 days（before vaccination） and 28 day after the vaccination ]
    To compared the positive conversion rate of Muv hemagglutination inhibition antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml but ＜3.5logCCID50/ml,high dose：≥4.5logCCID50/ml,active comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)
  • Positive conversion rate of Muv neutralization antibody of different single dose of Muv Vaccine [ Time Frame: the 0 days（before vaccination） and 28 day after the vaccination ]
    To compared the positive conversion rate of Muv neutralization antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml but ＜3.5logCCID50/ml,high dose：≥4.5logCCID50/ml,active comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The GMT of the hemagglutination inhibition antibody and neutralizing antibody [ Time Frame: the 0 days（before vaccination） and the 28 day after the vaccination ]
    evaluate the GMT of the hemagglutination inhibition antibody and neutralizing antibody in serum after the subjects get injected different dose of vaccine
  • The GMT of the neutralizing antibody [ Time Frame: the 0 days（before vaccination） and the 28 day after the vaccination ]
    evaluate the GMT of the neutralizing antibody in serum after the subjects get injected different dose of vaccine
  • The incidence rate of ADR after vaccination [ Time Frame: within the first 28 days after the vaccination ]
    Study the incidence rate of ADR after vaccination
  • viral shedding after the vaccination [ Time Frame: the 0（before vaccination）,4,10 days after the vaccination ]
    Using the method of PCR to detection the viral shedding of Muv after the vaccination.


Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences

Dates:
Date Received: April 17, 2017
Date Started: May 1, 2017
Date Completion: July 1, 2018
Last Updated: April 25, 2017
Last Verified: April 2017