Superior immunogenicity of a freeze-dried, cell culture-derived Japanese encephalitis vaccine (inactivated)

Kikukawa, Akiko; Gomi, Yasuo; Akechi, Masateru; Onishi, Toshiyuki; Manabe, Sadao; Namazue, Junko; Fuke, Isao; Ishikawa, Takahiro; Okuno, Yoshinobu; Ueda, Shigeharu

doi:10.1016/j.vaccine.2012.01.054

Cited by 20 publications

(17 citation statements)

References 13 publications

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“…To address this situation, two new freeze-dried inactivated cell culture JE vaccines (CC-JEV) produced using the Beijing-1 strain were approved as substitutes for the MB-JEV in Japan: JeBIK-V (Biken, The Research Foundation for Microbial Diseases of Osaka University, Kagawa, Japan), approved in 2009, and Encevac (Kaketsuken, the Chemo-Sero-Therapeutic Research Institute, Ku-mamoto, Japan), approved in 2011. In mice, JeBIK-V showed superior neutralizing antibody titers compared with those of MB-JEV (8). The safety and immunogenicity of JeBIK-V were also shown in children (9).…”

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confidence: 82%

Phase III Clinical Trials Comparing the Immunogenicity and Safety of the Vero Cell-Derived Japanese Encephalitis Vaccine Encevac with Those of Mouse Brain-Derived Vaccine by Using the Beijing-1 Strain

Miyazaki

Okada

Ozaki

et al. 2013

Clin. Vaccine Immunol.

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The immunogenicity and safety of an inactivated cell culture Japanese encephalitis vaccine (CC-JEV) were compared with those of an inactivated mouse brain-derived Japanese encephalitis vaccine (MB-JEV) in phase III clinical multicenter trials conducted in children. The vaccines contain the same Japanese encephalitis virus strain, the Beijing-1 strain. Two independent clinical trials (trials 1 and 2) were conducted. Trial 1 was conducted in 468 healthy children. Each subject was injected with 17 g per dose of either CC-JEV or MB-JEV, and the immunogenicity and safety of the vaccines were investigated. Trial 1 showed that CC-JEV was more immunogenic and reactive than MB-JEV at the same dose. Therefore, to adjust the immunogenicity of CC-JEV to that of MB-JEV, a vaccine that has had a good track record regarding its efficacy for a long time, trial 2 was conducted in 484 healthy children. To improve the stability, CC-JEV was converted from a liquid type to a freeze-dried type of vaccine. Each subject was injected subcutaneously with either 4 g per dose of CC-JEV, 8 g per dose of CC-JEV, or 17 g per dose of MB-JEV twice, at an interval of 2 to 4 weeks, followed by an additional booster immunization 1 to 15 months after the primary immunization. Based on the results of trial 2, 4 g per dose of the freeze-dried CC-JEV (under the label Encevac) was selected as a substitute for the MB-JEV. Encevac was approved and launched in 2011 and has since been in use as a 2nd-generation Japanese encephalitis vaccine in Japan. (These studies have been registered at the JapicCTI under registration no. JapicCTI-132063 and JapicCTI-080586 for trials 1 and 2, respectively.) J apanese encephalitis (JE) is an infectious disease caused by the JE virus (JEV), which is mediated by mosquitoes, such as Culex tritaeniorhynchus (1, 2). JE occurs not only in Japan but also in many other Asian countries, including Korea, Taiwan, China, Vietnam, Thailand, Malaysia, Myanmar, and India (3). The number of cases and fatalities due to JE are reported to be about 20,000 and 600 per year, respectively (1). To prevent this infectious disease, a JE vaccine derived from infected mouse brain tissue has been in use for a long time in Japan and other countries. Concurrently, a live-attenuated vaccine developed from a passaged culture of the JEV SA14 strain in primary hamster kidney cells and animals (mice and hamsters) with successive plaque purifications in primary chicken embryo cells, SA14-14-2, has been in use since 1989 in China and other countries (4). Moreover, an inactivated vaccine produced using the SA14-14-2 vaccine strain has been licensed in the United States, Europe, Canada, and Australia (5).In Japan, mouse brain-derived JE vaccine (MB-JEV) was initially produced using mouse brains inoculated with JEV Nakayama-NIH as a vaccine virus strain. At that time, MB-JEV was produced by adding formalin to the centrifugal supernatant of a 5% emulsion of mouse brain to inactivate the JE virus (6). Later, the quality of MB-JEV was improved through purificatio...

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confidence: 82%

Phase III Clinical Trials Comparing the Immunogenicity and Safety of the Vero Cell-Derived Japanese Encephalitis Vaccine Encevac with Those of Mouse Brain-Derived Vaccine by Using the Beijing-1 Strain

Miyazaki

Okada

Ozaki

et al. 2013

Clin. Vaccine Immunol.

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“…More recently, Vero cell-derived inactivated JE vaccines have been licensed in several countries including Japan. 2 The manufacturing of vaccines for viral diseases is switching from slow labor-intensive egg-based or in vivo production to rapid mammalian cell culture-based production.…”

mentioning

confidence: 99%

Production of Japanese encephalitis virus-like particles in insect cells

Yamaji

Konishi

2013

Bioengineered

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“…The protective effect of vaccine after 12-15 months was 98.5% (95%CI, 90.1-99.2%), 57 and maintained at 96.2% (95%CI, 73.1-99.9%) 5 years after administration of a single dose. 56 Inactivated, Vero cell-derived JE vaccines In a phase I trial, the seroconversion rate after the first dose of inactivated, Vero cell-derived JE vaccine and MBJEV groups were 96.7% and 92.9%, respectively, while the seroconversion rate was 100% after the second dose of both vaccines.…”

Section: Live Attenuated Sa14-14-2 Virus Vaccinementioning

confidence: 96%

“…13,14,[56][57][58] The pooled OR was 0.07 (95%CI, 0.02-0.31) with a moderate heterogeneity (I 2 D 21.84%) (Figure 2). The funnel plot was not symmetric (data not shown) and the Egger's test was significant (P D 0.02), which indicated a high probability of publication bias.…”

Section: Live Attenuated Sa14-14-2 Virus Vaccinementioning

confidence: 99%

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Immunogenicity and safety of currently available Japanese encephalitis vaccines: A systematic review

Li¹,

Xie

et al. 2014

Human Vaccines & Immunotherapeutics

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Superior immunogenicity of a freeze-dried, cell culture-derived Japanese encephalitis vaccine (inactivated)

Cited by 20 publications

References 13 publications

Phase III Clinical Trials Comparing the Immunogenicity and Safety of the Vero Cell-Derived Japanese Encephalitis Vaccine Encevac with Those of Mouse Brain-Derived Vaccine by Using the Beijing-1 Strain

Phase III Clinical Trials Comparing the Immunogenicity and Safety of the Vero Cell-Derived Japanese Encephalitis Vaccine Encevac with Those of Mouse Brain-Derived Vaccine by Using the Beijing-1 Strain

Production of Japanese encephalitis virus-like particles in insect cells

Immunogenicity and safety of currently available Japanese encephalitis vaccines: A systematic review

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