Safety and Efficacy of a Recombinant Hepatitis E Vaccine

• Published in: The New England journal of medicine Vol. 356; no. 9; pp. 895 - 903
• Main Authors: Shrestha, Sanjaya Kumar, Shrestha, Mrigendra Prasad, Scott, Robert McNair, Joshi, Durga Man, Mammen, Mammen P, Thapa, Gyan Bahadur, Thapa, Narbada, Myint, Khin Saw Aye, Fourneau, Marc, Kuschner, Robert A, David, Marie Pierre, Seriwatana, Jitvimol, Vaughn, David W, Safary, Assad, Endy, Timothy P, Innis, Bruce L
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 01.03.2007
• Subjects: Adolescent; Adult; Armed forces; Biological and medical sciences; Female; General aspects; Genotype & phenotype; Hepatitis; Hepatitis Antibodies - blood; Hepatitis E - epidemiology; Hepatitis E - prevention & control; Hepatitis E virus; Hepatitis E virus - immunology; Human viral diseases; Humans; Incidence; Infectious diseases; Kaplan-Meier Estimate; Male; Medical research; Medical sciences; Middle Aged; Treatment Outcome; Vaccines; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Viral diseases; Viral hepatitis; Viral Hepatitis Vaccines - administration & dosage; Viral Hepatitis Vaccines - adverse effects; Viral Hepatitis Vaccines - immunology; Nepal; Toxicity; Treatment efficiency; Vaccination; Hepatic disease; Vaccine; Infection; Medicine; Viral hepatitis A; Immunoprophylaxis; Viral disease; Digestive diseases; Recombinant protein; Safety
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa061847

Seroprevalence studies suggest that one third of the world's population has been infected with hepatitis E virus (HEV). Infection, especially during pregnancy, is associated with substantial rates of death and complications. No vaccine or specific therapy has been available for the treatment of HEV infection. In this double-blind, placebo-controlled trial involving 2000 subjects in Nepal, the administration of three doses of a novel recombinant HEV vaccine had 95.5% efficacy. Seroprevalence studies suggest that one third of the world's population has been infected with hepatitis E virus (HEV). In this trial involving 2000 subjects in Nepal, the administration of three doses of a novel recombinant HEV vaccine had 95.5% efficacy. Hepatitis E virus (HEV) infection is a major public health problem in many developing countries. 1 Hepatitis E occurs sporadically and in epidemics, causing substantial rates of death and complications, especially in pregnant women. 2 On the basis of seroprevalence, an estimated one third of the world's population has been infected with HEV. 3 In India, the lifetime infection risk is more than 60%, which translates to hundreds of thousands of illnesses annually. 4 Hepatitis E is usually self-limited and typically occurs in locations where laboratory diagnosis is unavailable. 5 Consequently, the true burden of hepatitis E is unknown. Hepatitis E is clinically indistinguishable from . . .