Long-Term Efficacy of a Hepatitis E Vaccine

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Abstract

Hepatitis E virus (HEV) is a leading cause of acute hepatitis. The long-term efficacy of a hepatitis E vaccine needs to be determined.

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Most cited references 14

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Persistent carriage of hepatitis E virus in patients with HIV infection.

Harry R. Dalton, Richard Bendall, Frances E Keane … (2009)

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Safety and efficacy of a recombinant hepatitis E vaccine.

Marc Fourneau, Khin Saw Aye Myint, Sanjaya Shrestha … (2007)

Hepatitis E virus (HEV) is an important cause of viral hepatitis. We evaluated the safety and efficacy of an HEV recombinant protein (rHEV) vaccine in a phase 2, randomized, double-blind, placebo-controlled trial. In Nepal, we studied 2000 healthy adults susceptible to HEV infection who were randomly assigned to receive three doses of either the rHEV vaccine or placebo at months 0, 1, and 6. Active (including hospital) surveillance was used to identify acute hepatitis and adverse events. The primary end point was the development of hepatitis E after three vaccine doses. A total of 1794 subjects (898 in the vaccine group and 896 in the placebo group) received three vaccine doses; the total vaccinated cohort was followed for a median of 804 days. After three vaccine doses, hepatitis E developed in 69 subjects, of whom 66 were in the placebo group. The vaccine efficacy was 95.5% (95% confidence interval [CI], 85.6 to 98.6). In an intention-to-treat analysis that included all 87 subjects in whom hepatitis E developed after the first vaccine dose, 9 subjects were in the vaccine group, with a vaccine efficacy of 88.5% (95% CI, 77.1 to 94.2). Among subjects in a subgroup randomly selected for analysis of injection-site findings and general symptoms (reactogenicity subgroup) during the 8-day period after the administration of any dose, the proportion of subjects with adverse events was similar in the two study groups, except that injection-site pain was increased in the vaccine group (P=0.03). In a high-risk population, the rHEV vaccine was effective in the prevention of hepatitis E. (ClinicalTrials.gov number, NCT00287469 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.

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Hepatitis E virus (HEV) infection in patients with cirrhosis is associated with rapid decompensation and death.

Sushree Mohanty, Kaushal Madan, J. Jha … (2007)

India is hyper-endemic for hepatitis E virus (HEV). HEV infection in cirrhosis may cause high mortality. Prospective study evaluating HEV infection in cirrhotics is scarce. Consecutive patients with cirrhosis and healthy controls were included. Cirrhotics were categorized to 3 groups, (Group I - rapid decompensation, Group II - chronically decompensated, Group III - cirrhotics without decompensation). Sera from cirrhotics and controls were tested for HEV-RNA (RT-PCR). HEV-RNA positivity among cirrhotics and controls was compared. Natural course and mortality rate between HEV infected and non-infected cirrhotics were assessed during a 12-month follow-up. 107 cirrhotics and 200 controls were included. 30 (28%) cirrhotics and 9 (4.5%) controls had detectable HEV-RNA (p<0.001). HEV- RNA positivity among Group I (n=42), II (n=32) and III (n=33) cirrhotics was 21 (50%), 6 (19%) and 3 (10%), respectively (p=0.002). 70% (21/30) with HEV infection and 27% (21/77) without it had rapid decompensation (p=0.001). Mortality between HEV infected and non-infected cirrhotics at 4 weeks (43% vs. 22%, p=0.001) and 12 month (70% vs. 30%, p=0.001) was different. Multivariate analysis identified HEV infection, Child-Pugh's score, renal failure, and sepsis as independent factors for mortality. In India, cirrhotics were prone to HEV infection, which was associated with rapid decompensation and death.