Long-Term Efficacy of a Hepatitis E Vaccine

Zhang, Jun; Zhang, Xuefeng; Huang, Shou-Jie; Wu, Ting; Hu, Yuemei; Wang, Zhongze; Wang, Hua; Jiang, Han-Min; Wang, Yijun; Yan, Qiang; Guo, Meng; Liu, Xiaohui; Li, Jingxin; Yang, Chang‐Lin; Tang, Qiulin; Jiang, Rong; Pan, Huirong; Li, Yimin; Shih, J. Wai-Kuo; Ng, Mun‐Hon; Zhu, Fengcai; Xia, Ningshao

doi:10.1056/nejmoa1406011

Cited by 324 publications

(259 citation statements)

References 24 publications

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“…HEV239 was thus, the first HEV vaccine licensed under the trade name of Hecolin® (Innovax Biotech, Xiamen, China) for commercial distribution in China in 2012. Further, the long term efficacy of Hecolin® for up to 4.5 years was 86.8% in men and women aged 16-65 years [12] . However, until now Hecolin® is available only in China, and it is unclear whether this vaccine could provide protection outside China irrespective of ethnicity as well as other genotypes, especially HEV3 in Western countries.…”

Section: Hepatitis E Vaccine: Time To Let the Cat Out…!mentioning

confidence: 92%

Hepatitis E Vaccine: Time to Let the Cat Out…!

Parvez

2017

Journal of Gastroenterology and Hepatology Research

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Section: Hepatitis E Vaccine: Time To Let the Cat Out…!mentioning

confidence: 92%

Hepatitis E Vaccine: Time to Let the Cat Out…!

Parvez

2017

Journal of Gastroenterology and Hepatology Research

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“…On extended follow up, up to 4.5 years, the vaccine was found to have efficacy of 86.8% [67] . However, the ability of the vaccine to protect against different genotypes of the virus is as yet unclear, and data regarding its safety and efficacy in persons with chronic liver disease, and other vulnerable populations are needed prior to making recommendations for its widespread use.…”

Section: Vaccination For Hepatitis Ementioning

confidence: 95%

Chronic hepatitis E: A brief review

Murali

Kotwal

Chawla

2015

WJH

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Hepatitis E viral infection has traditionally been considered an acute, self-limited, water borne disease similar to hepatitis A, endemic to developing countries. However, over the past decade, zoonotic transmission and progression to chronicity in human patients has been identified, resulting in persistently elevated transaminase levels, progressive liver injury and cirrhosis. In addition to liver injury, neurological, renal and rheumatological manifestations have also been reported. Chronic hepatitis E occurs mainly in immunosuppressed individuals such as transplant recipients, human immunodeficiency virus patients with low CD4 counts and in patients with hematological malignancies receiving chemotherapy. Diagnosis is established by persistent elevation of hepatitis E virus RNA in the stool or serum. This population often requires treatment with antiviral agents, particularly ribavirin, as spontaneous clearance with reduction in immunosuppression occurs only in about a third of the patients. The purpose of this review, is to further discuss the clinical presentation, and recent advances in diagnosis, treatment and prophylaxis of chronic hepatitis E.

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“…The geometric mean concentration (GMC) of antibody dropped quickly from a peak of 14.96 Wu/ml at month 7, which is higher than the level induced by natural HEV infection (0.6 Wu/ml) but lower than that induced after symptomatic hepatitis E disease (80.9 Wu/ ml), to 1.47 Wu/ml for the first year. 37,38 The concentration then slowly decreased to 0.27 Wu/ml by month 55. Although the antibody decayed to a relative low level at this time point, the long-term efficacy until month 54 is still as high as 93% (95% CI, 79-98) in the PPS cohort, the need and timing for a booster dose of HEV 239 remains to be further investigated.…”

Section: Efficacy Of Hev 239mentioning

confidence: 96%

“…In an extended efficacy study, 37 all participants in the Phase III trial were followed for another 3 y using the same local hepatitis surveillance system used during the Phase III trial. The longterm efficacy of HEV 239 for up to 4.5 y was demonstrated to be 93% (95% CI, 79 -98) in the PPS cohort and 87% (95% CI, 71 -94) in the ITT cohort.…”

Section: Efficacy Of Hev 239mentioning

confidence: 99%

The development of a recombinant hepatitis E vaccine HEV 239

Zhao

et al. 2015

Human Vaccines & Immunotherapeutics

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108

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Hepatitis E virus (HEV) infection is one of the main causes of acute hepatitis worldwide. A recombinant hepatitis E vaccine, HEV 239, has been licensed in China for immunizing adults of 16 y old and above. The vaccine antigen contains pORF2 aa 368 -606 of the HEV genotype 1 expressed in E. coli. The quality of the vaccine is controlled through a combination of biophysical, biochemical and immunochemical methods. The vaccine is well tolerated in adults. The efficacy of the HEV 239 vaccine against symptomatic and asymptomatic infection had been proven to be high during a Phase III clinical trial and long-term follow up. The safety and efficacy of HEV 239 vaccine in certain high-risk populations remains to be further investigated.

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Long-Term Efficacy of a Hepatitis E Vaccine

Abstract: Immunization with this hepatitis E vaccine induced antibodies against HEV and provided protection against hepatitis E for up to 4.5 years. (Funded by the Chinese Ministry of Science and Technology and others; ClinicalTrials.gov number, NCT01014845.).

Cited by 324 publications

References 24 publications

Hepatitis E Vaccine: Time to Let the Cat Out…!

Hepatitis E Vaccine: Time to Let the Cat Out…!

Chronic hepatitis E: A brief review

The development of a recombinant hepatitis E vaccine HEV 239

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