icddr,b wins major award to help prevent Hepatitis E in pregnancy

icddr,b scientists have received a global health and vaccination award from GLOBVAC to conduct research on a vaccine for hepatitis E, a troubling viral disease that causes particularly dangerous problems in pregnant women.

GLOBVAC – global health and vaccination research – is based in Norway and supports high-quality research with potential for high impact that can contribute to sustainable improvements in health and health equity for poor people in low- and lower-middle income countries.

Photo by DFAT. CC BY 2.0.

icddr,b senior scientist Dr K Zaman and collaborators with the Norwegian Institute of Public Health received a US $5.5 million grant to conduct an effectiveness trial evaluating the protection of pregnant women by a hepatitis E vaccine in Bangladesh and the risk factors for severe hepatitis E infection.

Hepatitis E remains a significant public health problem in countries like Bangladesh where drinking water and food are frequently contaminated with human feces.  Pregnant woman and their fetuses and newborns bear the greatest burden from hepatitis E. Although the overall case fatality rate is just 1-3%, it rises to 5-25% among pregnant women. Membrane rupture, spontaneous abortions, stillbirth and high neonatal mortality are associated with hepatitis E infection in pregnancy.

The study will be conducted in rural Bangladesh at icddr,b’s Matlab fieldsite. All 67 villages in the icddr,b service area will be randomized by village at a 1:1 ratio to receive either hepatitis E vaccine or the control vaccine (hepatitis B vaccine). More than 20,000 non-pregnant women aged 16-39 years will be enrolled in the study, and vaccines will be administered as a 3-dose regimen on day 0, at one month and six months. Surveillance for hepatitis will continue for 2 years after the completion of all vaccinations to determine the vaccine is effective in preventing hepatitis E disease during pregnancy. 

The study will use hepatitis E vaccine HEV 239 (Hecolin) developed by China-based Xiamen University and Innovax Biotech. Animportant component of the study will be the establishment of technology transfer of the vaccine from Innovax to Bangladesh vaccine producer, Incepta, for production of a low-cost vaccine.

The data on hepatitis E vaccination feasibility, acceptability, effectiveness and cost-effectiveness from this study will provide critical information to inform policy on hepatitis E vaccine introduction for women of childbearing age in Bangladesh, and elsewhere in South Asia.

Dr. K. Zaman, says: “ if the hepatitis E vaccine is proven effective it will open an new era to further reduce maternal deaths and prevent complications during pregnancy particularly in developing countries.”

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