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.
Purcell
Robert H
RH
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
Nguyen
Hanh
H
Shapiro
Max
M
Engle
Ronald E
RE
Govindarajan
Sugantha
S
Blackwelder
William C
WC
Wong
Doris C
DC
Prieels
Jean Paul
JP
Emerson
Suzanne U
SU
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