Hepatitis E Vaccine Found to Be Effective and Safe

In phase 3 study, none receiving the vaccine developed hepatitis E versus 15 receiving placebo

MONDAY, Aug. 23 (HealthDay News) -- A recombinant hepatitis E vaccine (HEV 239) appears to be effective and well-tolerated in the general adult population, according to a study published online Aug. 23 in The Lancet.

In a double-blind, placebo-controlled, phase 3 study, Feng-Cai Zhu, of the Jiangsu Provincial Centre for Disease Control and Prevention in Nanjing, China, and colleagues randomized healthy individuals, aged 16 to 65 years, in a one-to-one ratio to receive three doses of HEV 239 or placebo (hepatitis B vaccine) given intramuscularly at zero, one, and six months.

Of the 48,693 participants receiving HEV 239 and the 48,663 receiving placebo included in the primary efficacy analysis, the investigators found that 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the HEV 239 group after 30 days from receipt of the third vaccine dose. HEV 239 efficacy after three doses was 100 percent, with few and mild adverse effects and no vaccination-related serious adverse events.

"Further studies are needed to assess the safety and to support the benefits of the vaccine for pregnant women and for people younger than 15 years or older than 65 years," the authors write.

HEV 239 is manufactured by Xiamen Innovax Biotech, and two authors are employees of the company.

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