The project aims to evaluate the protection against hepatitis E virus (HEV) disease in pregnant women by immunization with the HEV vaccine (Hecolin). HEV affects pregnant women and their fetuses in low income countries (LIC) with case-facility rates up to 25%. A cluster-randomized effectiveness trial (phase IV) will be conducted to assess the feasibility, acceptability, protective impact and cost-effectiveness of immunization of fertile women in Bangladesh. The vaccine is shown to be efficacious in an earlier phase III trial in China, but is currently only licensed in China. There is no data showing that this vaccine can prevent disease in pregnant women, the group that could benefit most from vaccination in this setting. The vaccine effect in preventing maternal and neonatal mortality will be assessed in this trial with 20.000 participants. Immunity against HEV, estimate of serological correlates of protection and risk factors for severe or fatal HEV will be investigated.
See the full project description at Cristin for more information about results, researchers, contact information etc.
Torbjørn Wisløff, National Institute of Public Health
Cathinka Halle Julin, Norwegian Institute of Public Health
Ida Laake, National Institute of Public Health
Jennifer Lynn Dembinski, National Institute of Public Health