Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial
Yan Liang1, Jingchen Ma2, Changgui Li3
1Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
Background:
Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas.
Methods:
A randomized, double-blind, controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted. A total of 300 subjects were enrolled and divided into 4 age groups: 16-60 years, 5-16 years, 2-5 years and 8-24 months. The groups were immunized with one injection per subject. Three different doses of the F-genotype attenuated mumps vaccine, A (3.5 ± 0.25 logCCID50), B (4.25 ± 0.25 logCCID50) and C (5.0 ± 0.25 logCCID50), as well as a placebo control and a positive control of a licensed A-genotype vaccine (S79 strain) were used. The safety and immunogenicity of this vaccine were compared with those of the controls.
Results:
The safety evaluation suggested that mild adverse reactions were observed in all groups. No serious adverse event (SAE) was reported throughout the trial. The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2- to 5-year-old and 8- to 24-month-old groups compared with the seroconversion rate in the positive control. The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group.
Conclusions:
The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control.
Insights
A new F-genotype attenuated mumps vaccine shows promise for controlling mumps outbreaks. This phase I trial found the vaccine to be safe and immunogenic across various age groups, offering a potential new tool against mumps resurgence.
Area of Science:
- Virology
- Immunology
- Vaccinology
Background:
- Mumps is a contagious disease that has seen recent resurgences despite previous control measures.
- Effective vaccination strategies are crucial for managing mumps outbreaks.
Purpose of the Study:
- To evaluate the safety and immunogenicity of a novel F-genotype attenuated mumps vaccine.
- To compare the vaccine's performance against placebo and a licensed A-genotype mumps vaccine.
Main Methods:
- A randomized, double-blind, controlled phase I study involving 300 subjects across four age groups (8 months to 60 years).
- Administration of three different doses of the F-genotype vaccine, a placebo, and a licensed A-genotype vaccine.
- Assessment of safety through adverse event monitoring and immunogenicity via seroconversion rates and antibody titers.
Main Results:
- The F-genotype mumps vaccine was well-tolerated, with only mild adverse reactions observed and no serious adverse events reported.
- Immunogenicity results showed comparable seroconversion rates to the positive control in younger age groups (8-24 months and 2-5 years).
- Geometric Mean Titer (GMT) of neutralizing antibodies against the F-genotype virus was slightly higher in vaccine groups compared to the positive control.
Conclusions:
- The F-genotype attenuated mumps vaccine is safe and demonstrates effective immunogenicity.
- This vaccine represents a potentially valuable addition to mumps prevention strategies.
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