Drug intelligence / Profile preview

Hepatitis E vaccine, recombinant (Sar 56 kDa)

Development stage
Discontinued
Lead developer
U.S. Army Medical Research and Development Command
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

This is a recombinant protein subunit vaccine developed to prevent infection by the Hepatitis E virus (HEV). It was developed through a collaboration between the U.S. Army Medical Research and Development Command (USAMRMC) and GlaxoSmithKline (GSK). The vaccine consists of a 56 kDa truncated recombinant protein derived from the capsid protein (ORF2) of a genotype 1 Hepatitis E virus strain (Sar-55). In a large Phase II clinical trial involving 2,000 Nepalese soldiers, the vaccine demonstrated high safety and an efficacy of 95.5% after a three-dose regimen (0, 1, and 6 months). Despite these results, further development was halted by GSK due to perceived low commercial viability, and the vaccine has not proceeded to Phase III or licensure.

Other names
hepatitis e vaccine, recombinant-U.S. Army Medical Research and Development Command-hepatitis EUSAMRMC Hepatitis E VaccineGSK Hepatitis E VaccineHepatitis E vaccine, recombinant (Sar 55)
02

Targets

HEV ORF2 (Hepatitis E virus capsid protein)

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