Pre-clinical immunogenicity and efficacy trial of a recombinant hepatitis E vaccine

• Published in: Vaccine Vol. 21; no. 19; pp. 2607 - 2615
• Main Authors: Purcell, Robert H, Nguyen, Hanh, Shapiro, Max, Engle, Ronald E, Govindarajan, Sugantha, Blackwelder, William C, Wong, Doris C, Prieels, Jean-Paul, Emerson, Suzanne U
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 02.06.2003; Elsevier; Elsevier Limited
• Subjects: Animals; Antibodies, Viral - blood; Antibody Formation; Base Sequence; Biological and medical sciences; Cell culture; Clinical trials; Disease; Disease Models, Animal; DNA Primers; Fundamental and applied biological sciences. Psychology; Genotype & phenotype; Genotypes; Hepatitis; Hepatitis E; Hepatitis E - immunology; Hepatitis E - prevention & control; Hepatitis E virus; Hepatitis E virus - genetics; Hepatitis E virus - immunology; Human viral diseases; Immunogenicity; Infections; Infectious diseases; Injections, Intramuscular; Macaca mulatta; Medical sciences; Microbiology; Monkey; Mortality; Proteins; Reverse Transcriptase Polymerase Chain Reaction; Vaccine; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - immunology; Vaccines, Synthetic - pharmacology; Viral diseases; Viral hepatitis; Viral Hepatitis Vaccines - administration & dosage; Viral Hepatitis Vaccines - immunology; Viral Hepatitis Vaccines - pharmacology; Virology; Viruses; Asia; Mexico; Hepatitis E; Vaccine; Monkey; Toxicity; Hepatic disease; Hepatitis E virus; Infection; Virus; Prevention; Immunoprophylaxis; Calicivirus; Immunogenicity; Caliciviridae; Viral disease; Digestive diseases; Clinical trial; Viral hepatitis E
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/S0264-410X(03)00100-2

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.