Hepatitis E virus is an important cause of viral hepatitis.
Dr Bruce Innis and colleagues from Pennsylvania evaluated the safety and efficacy of an Hepatitis E virus recombinant protein vaccine.
The research team conducted a phase 2, randomized, double-blind, placebo-controlled trial.
The team assessed 1794 of 2000 healthy adults susceptible to Hepatitis E virus infection in Nepal.
The subjects were randomly assigned to receive 3 doses of either the Hepatitis E virus recombinant protein vaccine or placebo at months 0, 1, and 6.
The researchers used active surveillance to identify acute Hepatitis and adverse events.
The primary end point was the development of Hepatitis E after 3 vaccine doses.
|The vaccine efficacy was 96%|
|The New England Journal of Medicine|
The researchers reported that 898 subjects were in the vaccine group, and 896 in the placebo group.
The total vaccinated cohort was followed for a median of 804 days.
The team observed that after 3 vaccine doses, Hepatitis E developed in 69 subjects, of whom 66 were in the placebo group.
The vaccine efficacy was 96%.
The researchers also performed an intention-to-treat analysis that included all 87 subjects in whom Hepatitis E developed after the first vaccine dose.
In these subjects, the team noted that 9 were in the vaccine group, with a vaccine efficacy of 89%.
In addition, subjects were randomly selected for subgroup analysis of injection-site findings and general symptoms at 8-days after the administration of any dose.
The team found that the proportion of subjects with adverse events was similar in the 2 study groups.
However, the researchers observed that injection-site pain was increased in the vaccine group.
Dr Innis' team commented, “In a high-risk population, the Hepatitis E virus recombinant protein vaccine was effective in the prevention of Hepatitis E.