Safety and Efficacy of a Hepatitis E Virus Vaccine Conducted in Nepal
Abstract
Hepatitis E virus (HEV) causes hepatitis E, a public health problem in many developing countries. Several outbreaks of hepatitis E have been reported in military environments. We evaluated the safety and efficacy of a HEV recombinant protein (rHEV) vaccine in a randomized, double-blinded, placebo-controlled trial. In Nepal, we studied 2,000 healthy adults susceptible to HEV who were randomized to receive 3 doses of either the rHEV vaccine (1,000) or placebo (1,000) at months 0, 1 and 6. Active and hospital surveillance were used to identify acute hepatitis and adverse events. The primary endpoint was hepatitis E occurring after 3 vaccine doses.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 01, 2006
- Accession Number
- ADA481583
Entities
People
- A. Safary
- B. L. Innis
- D. M. Joshi
- D. W. Vaughn
- David M. Fourneau
- G. B. Thapa
- J. Seriwatana
- K. S. Myint
- M. P. Mammen
- M. P. Shrestha
- N. Thapa
- R. A. Kuschner
- R. M. Scott
- Sujan Shrestha
- T. P. Endy
Organizations
- Armed Forces Research Institute of Medical Sciences