Clinical Trial: A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Clinical Trial for Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children

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:
Sponsor: Chinese Academy of Medical Sciences

Current Primary Outcome:

• Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults. [ Time Frame: within the first 28 days after the vaccination ]
  Adverse reactions associated with vaccine were observed in Chinese Adults (from 16 to 59 years old) after the vaccination
• Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children. [ Time Frame: within the first 28 days after the vaccination ]
  Adverse reactions associated with vaccine were observed in Chinese Children (from 5 to 15 years old) after the vaccination.
• Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children. [ Time Frame: within the first 28 days after the vaccination ]
  Adverse reactions associated with vaccine were observed in Chinese Children (from 2 to 4 years old) after the vaccination.
• Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants. [ Time Frame: within the first 28 days after the vaccination ]
  Adverse reactions associated with vaccine were observed in Chinese Infants (from 8 to 23 months old) after the vaccination.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination. [ Time Frame: within the first 28 days after the vaccination ]

  The seroconversion rate of anti-MuV antibodies was evaluated in serum of adults at the 0 and 28 days after vaccination.

  The seroconversion rate of anti-MuV antibodies was evaluated in serum of children at the 0 and 28 days after vaccination.

  The seroconversion rate of anti-MuV antibodies was evaluated in serum of infants at the 0 and 28 days after vaccination.

• Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infants, after vaccination [ Time Frame: within the first 4 days after the vaccination ]

  The abnormity change of live and kidney function indexes were evaluated in serum of adults at 0, 4 days after vaccination.

  The abnormity change of live and kidney function indexes were evaluated in serum of children at 0, 4 days after vaccination.

  The abnormity change of live and kidney function indexes were evaluated in serum of infants at 0, 4 days after vaccination.

Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences

Dates:
Date Received: October 22, 2012
Date Started: October 2012
Date Completion:
Last Updated: April 26, 2013
Last Verified: October 2012