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  • HEV vaksinestudie hos fertile kvinner i Bangladesh og risikofaktorer for alvorlig HEV

Project

HEV vaksinestudie hos fertile kvinner i Bangladesh og risikofaktorer for alvorlig HEV - project description

Published Updated

The project aims to evaluate the protection against hepatitis E virus (HEV) disease in pregnant women by immunization with the HEV vaccine (Hecolin).


Summary

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.

Project participants

Project leader

Susanne Dudman, Norwegian Institute of Public Health

Project participants

Joakim Øverbø, Norwegian Institute of Public Health
Synne Sandbu, Norwegian Institute of Public Health
Kathrine Stene-Johansen, Norwegian Institute of Public Health
Ida Laake, National Institute of Public Health
Torbjørn Wisløff, National Institute of Public Health
Jennifer Lynn Dembinski, National Institute of Public Health
Cathinka Halle Julin, Norwegian Institute of Public Health

Start

01.01.2016

End

31.03.2021

Status

Concluded

Approvals

Regional committees for medical and health research ethics

Project owner/ Project manager

Norwegian Institute of Public Health