Dataset Information

Agranulocytosis following injection of inactivated Japanese encephalitis vaccine (Vero cell): A case report.

ABSTRACT:

Background

Japanese encephalitis virus (JEV), a mosquito borne flavivirus, is the leading cause of viral encephalitis in Asia, in terms of frequency and severity. JEV infection is thought to confer lifelong immunity. With the near eradication of poliomyelitis, JEV is now the continent's leading cause of childhood viral neurologic infection and disability. The most common clinical manifestation of JEV infection is acute encephalitis, and currently there is no specific antiviral therapy. Japanese Encephalitis Vaccine (JE-VC) is an effective prevention measure, including JE-VC, Live (JE-MB), and Inactivated JE-VC.

Case summary

A 9-mo-old girl received injection of Inactivated JE-VC (Vero cell) (Liaoning Chengda, batch number 201611B17) on August 31, 2017. On that night, she developed a fever with the body temperature up to 38.5 °C, for which Ibuprofen Suspension Drops 1.25 mL was given as antipyretic treatment. On September 1, the patient developed apocleisis, and her parents noticed herpes in her oral cavity. The patient was sent to our hospital on September 3. Physical examination led to a diagnosis of herpetic stomatitis, for which Stomatitis Spray 1 puff, tid, Kangfuxin Liquid 2 mL, tid, and vitamin B₂ 0.5 tablet, tid, were prescribed. Routine blood tests for low fever on September 6, 2017 revealed an absolute neutrophil count (ANC) of 0.62 × 10⁹/L, hemoglobin (Hb) of 109 g/L, and platelet count (PLT) of 308 × 10¹²/L, and the tests were monitored regularly thereafter. The patient was followed until July 26, 2020, when routine blood tests revealed ANC 1.72 × 10⁹/L, Hb 138 g/L, and PLT 309 × 10¹²/L, indicating that the neutropenia count had normalized.

Conclusion

This report attempts to bring to clinical attention that Inactivated JE-VC (Vero cell) might cause prolonged granulocytopenia or even agranulocytosis.

SUBMITTER: Wang L

PROVIDER: S-EPMC8464466 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Although mouse brain-derived, inactivated Japanese encephalitis vaccines (JE-MBs) have been successfully used for a long time, potential rare neurological complications have prompted the development of a Vero cell culture-derived inactivated vaccine (JE-VC). In a phase III clinical study, we aimed to compare the safety and immunogenicity of a JE-VC, KD-287 with a JE-MB, JEV-GCC, in children.In this multicenter, double-blinded, randomized controlled trial, the study population consisted of 205 healthy Korean children aged 12-23 months. Each subject was subcutaneously vaccinated with either KD-287 or JEV-GCC twice at an interval of 2 weeks and then vaccinated once 12 months after the second vaccination. Neutralizing antibodies were measured by the plaque reduction neutralization test using the homologous and heterologous, as a post hoc analysis, challenge virus strains.The three-dose regimen of KD-287 showed a comparable safety profile with JEV-GCC except higher incidence of fever after the first dose (30.4% and 14.7%, respectively). Most of the fever was mild degree (61.3% and 66.7%, respectively). KD-287 fulfilled the non-inferiority criteria for seroconversion rate (SCR) and geometric mean titer (GMT) of the neutralizing antibody, which were the primary endpoints, at 4 weeks after the third vaccination (95% CI: -1.00, 3.10 for the SCR difference and 10.8, 17.6 for the GMT ratio). The SCRs of KD-287 were all 100% and the GMTs were higher in the KD-287 group than in the JEV-GCC group after the second vaccination and before and after the third vaccination (GMT ratio: 5.59, 20.13, and 13.79, respectively, p?<?0.001 in all). GMTs were higher in the KD-287 group in the heterologous analysis also (GMT ratio: 4.05, 5.15, and 4.19, respectively, p?<?0.001 in all).This study suggests that the KD-287, a JE-VC is as safe as and may be more effective than the licensed MB-derived vaccine. KD-287 could thus be useful as a second-generation vaccine and substitute for the current JE-MB vaccine in Korean children.ClinicalTrials.gov: NCT01150942.