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Published on: April 15, 2014
[STUDY OF SAFETY OF PAROTITIS VACCINE]
Insights
This study monitored post-vaccinal complications in children receiving the Leningrad-3 strain (L-3) mumps vaccine. Results show low neurovirulence and reactogenicity, with rare vaccine-associated parotitis cases, suggesting vaccine safety.
Area of Science:
- Virology
- Immunology
- Pediatrics
Context:
- Monitoring vaccine safety is crucial for public health.
- The Leningrad-3 strain (L-3) mumps vaccine is widely used.
- Post-vaccinal complications require thorough investigation.
Purpose:
- To assess post-vaccinal complications in children immunized with the L-3 mumps vaccine.
- To evaluate the neurovirulence and reactogenicity of the L-3 mumps vaccine.
- To identify potential risk factors for adverse events.
Summary:
- A 3-year observational study involved 198,945 children vaccinated with 16 lots of L-3 mumps vaccine.
- Adverse events were monitored for 42 days post-vaccination, with serological and genetic analyses performed.
- Vaccine-associated aseptic meningitis was absent; vaccine-associated parotitis occurred in 0.06% of cases, with specific lots showing higher activity.
Impact:
- The L-3 mumps vaccine demonstrates low neurovirulence and reactogenicity.
- Specific vaccine lots were associated with a higher incidence of parotitis.
- A high immunization dose may contribute to post-vaccinal complications in some children.
Aim:
Monitoring of post-vaccinal complications in children immunized with a parotitis vaccine.
Materials And Methods:
Observation of 198 945 children, immunized with 16 lots of parotitis vaccine with Leningrad-3 strain (L-3), was carried out for 3 years. Paired samples of sera and saliva were obtained from children, in whom adverse events were registered for 42 days after vaccination. Titers of specific IgM and IgG were determined in blood sera. Analysis of nucleotide sequences of genes F, SH and NH of RNA of parotitis virus was carried out from samples of blood and saliva.
Results:
Intensive parameter of vaccine-associated aseptic meningitis under the conditions of the experiments was 0 for 100 000 immunized. Frequency of occurrence of post-vaccinal parotitis was 0.06% from the number of vaccinated--18 cases of vaccine-associated parotitis were registered and laboratory confirmed. A significant difference in specific activity was detected for 3 lots of the vaccine, that were associated with cases of development of parotitis, relative to that of 13 lots of vaccine, development of parotitis was not registered after administration of those.
Conclusion:
The study carried out confirmed low neurovirulence of the parotitis vaccine with the L-3 strain of parotitis virus, as well as a low degree of its reactogenicity. A relatively high immunization dose of the used vaccine could be one of the reasons of development of post-vaccinal complications in part of the immunized children.
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