Hepatitis E Vaccine Called Highly Effective

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To test the efficacy of the newly developed recombinant vaccine, 2,000 healthy adults -- 99.6 percent of them male -- from Nepal were randomly selected to receive either the vaccine or a placebo shot. All of the study volunteers were part of the Nepalese army.

The vaccine was administered in three doses, with the second dose given after a month and the third given at six months. The average follow-up time was 804 days. Innis said that political turmoil in Nepal added to the challenge of conducting a study in a country where there is little industrial development.

At the end of the study, complete follow-up data was available on 1,794 study volunteers -- 898 who received the vaccine and 896 from the placebo group.

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Hepatitis E developed in 69 people during the study period. Sixty-six of those infected were from the placebo group.

The vaccine's efficacy was 95.5 percent, according to the study.

Innis said the researchers were surprised by the high rates of hepatitis E infection. "We knew that there was a good amount of hepatitis E in this population, but the incidence of disease in the placebo group was about twice as high as we anticipated it would be," he said. "By immunizing against hepatitis E -- an orphan disease -- we had a substantial impact on the well-being of those vaccinated. We do believe this is a product that could relieve a great deal of human suffering."

Liver specialist Dr. Tusar Desai, of William Beaumont Hospital in Royal Oak, Mich., said the study's findings are "exciting." He said he wasn't concerned that the study was done mostly with men, because men and women tend to react similarly to vaccines.

What is a concern, Desai said, is that the researchers conducted the study with soldiers, who tend to be thin. And, he said, there is a difference in the way thin and overweight people process immunizations -- vaccines aren't as effective in people who carry extra weight.

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