Pre-clinical immunogenicity and efficacy trial of a recombinant hepatitis E vaccine.
We have demonstrated that recombinant hepatitis E vaccine suitable for clinical evaluation was highly immunogenic and efficacious in preventing hepatitis E and even infection in rhesus macaques following intravenous challenge with three different genotypes of hepatitis E virus (HEV). Two doses of vaccine were essential for optimal protection; the two-dose regimen was more important than the formulation of the vaccine for achieving efficacy. The titers of anti-HEV that were protective in this study were quantified against a World Health Organization (WHO) standard. This permits direct comparison of the results with other studies. The results of this pre-clinical trial of a candidate hepatitis E vaccine strongly suggest that it will be highly efficacious for preventing hepatitis E in the field trial of this vaccine that is currently in progress in Nepal.
Hepatitis Viruses and Molecular Hepatitis Sections, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 50 South Drive MSC-8009, Bethesda, MD 30333, USA. rpurcell@niaid.nih.gov
Robert H
RH
Purcell
Hanh
H
Nguyen
Max
M
Shapiro
Ronald E
RE
Engle
Sugantha
S
Govindarajan
William C
WC
Blackwelder
Doris C
DC
Wong
Jean Paul
JP
Prieels
Suzanne U
SU
Emerson
D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D001483:Base Sequence; D017931:DNA Primers; D004195:Disease Models, Animal; D016751:Hepatitis E / Q000276:immunology* / Q000517:prevention & control; D016752:Hepatitis E virus / Q000235:genetics / Q000276:immunology*; D007273:Injections, Intramuscular; D008253:Macaca mulatta; D020133:Reverse Transcriptase Polymerase Chain Reaction; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology* / Q000494:pharmacology; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000276:immunology* / Q000494:pharmacology
D000914:Antibodies, Viral; D017931:DNA Primers; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines