A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.

Phase 2 Completed 2000 enrolled U.S. Army Medical Research and Development Command GlaxoSmithKline · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to determine if a hepatitis E vaccine is safe and able to prevent symptomatic liver disease due to the hepatitis E virus.

Timeline

Start: 2001-07-09
Primary completion: 2004-01-19
Completion: 2005-01

Outcome

Met primary endpoint

paper After three vaccine doses, hepatitis E developed in 69 subjects, of whom 66 were in the placebo group. PMID 17329696 ↗

paper The vaccine efficacy was 95.5% (95% confidence interval [CI], 85.6 to 98.6). PMID 17329696 ↗

Publications

Background Worm HC, Schlauder GG, Brandstatter G. Hepatitis E and its emergence in non-endemic areas. Wien Klin Wochenschr. 2002 Aug 30;114(15-16):663-70.
Background Worm HC, van der Poel WH, Brandstatter G. Hepatitis E: an overview. Microbes Infect. 2002 May;4(6):657-66. doi: 10.1016/s1286-4579(02)01584-8.
Background Emerson SU, Purcell RH. Running like water--the omnipresence of hepatitis E. N Engl J Med. 2004 Dec 2;351(23):2367-8. doi: 10.1056/NEJMp048285. No abstract available.
Background Purcell RH. Hepatitis viruses: changing patterns of human disease. Proc Natl Acad Sci U S A. 1994 Mar 29;91(7):2401-6. doi: 10.1073/pnas.91.7.2401.
Background Worm HC, Wirnsberger G. Hepatitis E vaccines: progress and prospects. Drugs. 2004;64(14):1517-31. doi: 10.2165/00003495-200464140-00002.
Shrestha MP, Scott RM, Joshi DM, Mammen MP Jr, Thapa GB, Thapa N, Myint KS, Fourneau M, Kuschner RA, Shrestha SK, David MP, Seriwatana J, Vaughn DW, Safary A, Endy TP, Innis BL. Safety and efficacy of a recombinant hepatitis E vaccine. N Engl J Med. 2007 Mar 1;356(9):895-903. doi: 10.1056/NEJMoa061847.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sar 56 kDa	Protein / enzyme biologic	20 ug	Intramuscular