Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh.

Summary

The aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in women of child bearing age in preventing HEV disease during pregnancy among women in rural Bangladesh.

Timeline

Start

2017-10-02

Primary completion

2019-09-30

Completion

2019-09-30

Publications

• Overbo J, Dembinski JL, Nilsen TR, Sriranganathan V, Dimova-Svetoslavova VP, Aziz A, Zaman K, Julin CH, Qadri F, Stene-Johansen K, Bhuiyan TR, Haque W, Dudman S. Cellular and Humoral Immune Profiles After Hepatitis E Vaccination and Infection. Viruses. 2025 Jun 26;17(7):901. doi: 10.3390/v17070901.
• Aziz AB, Dudman S, Julin CH, Ahmmed F, Stene-Johansen K, Sandbu S, Overbo J, Dembinski JL, Wisloff T, Rana S, Basunia AH, Haque W, Qadri F, Zaman K, Clemens JD. Receipt of hepatitis E vaccine and fetal loss in rural Bangladesh: further analysis of a double-blind, cluster-randomised, controlled trial. Lancet Glob Health. 2024 Aug;12(8):e1300-e1311. doi: 10.1016/S2214-109X(24)00193-1.
• Zaman K, Julin CH, Aziz AB, Stene-Johansen K, Yunus M, Qadri F, Gurley ES, Sandbu S, Overbo J, Dembinski JL, Laake I, Bhuiyan TR, Rahman M, Haque W, Khanam M, Clemens JD, Dudman S. Safety and effectiveness of a recombinant hepatitis E vaccine in women of childbearing age in rural Bangladesh: a phase 4, double-blind, cluster-randomised, controlled trial. Lancet Glob Health. 2024 Aug;12(8):e1288-e1299. doi: 10.1016/S2214-109X(24)00192-X.
• Overbo J, Aziz A, Zaman K, Clemens J, Halle Julin C, Qadri F, Stene-Johansen K, Biswas R, Islam S, Rahman Bhuiyan T, Haque W, Sandbu S, Elahee ME, Ali M, Dembinski JL, Dudman S. Immunogenicity and safety of a two-dose regimen with hepatitis E virus vaccine in healthy adults in rural Bangladesh: A randomized, double-blind, controlled, phase 2/pilot trial. Vaccine. 2023 Jan 27;41(5):1059-1066. doi: 10.1016/j.vaccine.2022.12.064. Epub 2023 Jan 2.
• Zaman K, Dudman S, Stene-Johansen K, Qadri F, Yunus M, Sandbu S, Gurley ES, Overbo J, Julin CH, Dembinski JL, Nahar Q, Rahman A, Bhuiyan TR, Rahman M, Haque W, Khan J, Aziz A, Khanam M, Streatfield PK, Clemens JD. HEV study protocol : design of a cluster-randomised, blinded trial to assess the safety, immunogenicity and effectiveness of the hepatitis E vaccine HEV 239 (Hecolin) in women of childbearing age in rural Bangladesh. BMJ Open. 2020 Jan 19;10(1):e033702. doi: 10.1136/bmjopen-2019-033702.

Drugs

Indications