Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh.
NCT ID: NCT02759991
Last Updated: 2024-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
19460 participants
INTERVENTIONAL
2017-10-02
2019-09-30
Brief Summary
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Detailed Description
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The research plan has been carefully designed and will be conducted by a multidisciplinary team of researchers at International Centre for Diarrhoeal Disease Research (iccdr,b) in Bangladesh and the Norwegian Institute of Public Health and Innlandet Hospital Trust in Norway. Over a period of 2 years, 20,745 non-pregnant women will be recruited and will receive either the hepatitis E vaccine or a hepatitis B vaccine (control group). All women who develop hepatitis E symptoms will be tested for the disease. Those who become pregnant during the study will also be checked and tested during regular home visits. Clinical outcomes and vaccine adverse events will be closely monitored.
In order to evaluate the initial safety profile and immunogenicity of the vaccine, a pilot study was completed during summer 2017. A total of 100 non-pregnant females and males, aged 16-39, were enrolled and randomly received either the hepatitis E vaccine or a hepatitis B vaccine. Participants were vaccinated on day 0 and day 30, and blood, dried blood spots (DBS) and saliva samples were collected on day 0 and day 60 for use in laboratory assay validation and serological and cellular immunogenicity analyses. Following each vaccination, home visits were carried out for 7 days to record adverse reactions. No serious adverse reactions were observed, and only a few mild local adverse reactions were recorded which all resolved without sequela. Preliminary immunogenicity results, showed that 44 participants had seroconverted (HEV), after just two doses of the vaccine. Furthermore, during this pilot study the implementation of protocols and procedures for all stages of the trial were tested in preparation for the start of the main trial.
Additionally, hepatitis surveillance in Matlab has been initiated in order to establish an HEV surveillance system. All women aged 16-39 are included in the surveillance, and requested to contact icddr,b staff if they experience jaundice of any duration, or other symptoms of hepatitis. Patients admitted to Matlab hospital have a blood sample taken for hepatitis diagnostics, and acute HEV cases are investigated virologically, clinically and immunologically. Household visits occur bi-weekly to document any possible hepatitis cases.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. Main clinical trial designed to enroll 20.745 women aged 16-39 years living in Matlab area. All participants randomized to be vaccinated with either Hecolin or Hepa-B three doses.
PREVENTION
QUADRUPLE
Study Groups
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HEV vaccine
Hecolin, 0.6 ml intramuscular injection day 0, 1 month and 6 months.
Hecolin
0.6ml Hecolin vaccine im. on day 0, 1 month and 6 months.
HBV vaccine
Hepa-B, 1 ml intramuscular injection day 0, 1 month and 6 months.
Hepa-B
1ml Hepa-B vaccine im. on day 0, 1 month and 6 months.
Interventions
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Hecolin
0.6ml Hecolin vaccine im. on day 0, 1 month and 6 months.
Hepa-B
1ml Hepa-B vaccine im. on day 0, 1 month and 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Living in Matlab area
Exclusion Criteria
* Allergic to vaccine components
* Serious chronic diseases
* Acute illness
16 Years
39 Years
FEMALE
Yes
Sponsors
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International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Sykehuset Innlandet HF
OTHER
Norwegian Institute of Public Health
OTHER_GOV
Responsible Party
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Principal Investigators
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Susanne Dudman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian Institute of Public Health
K Zaman, PhD
Role: PRINCIPAL_INVESTIGATOR
International Centre for Diarrhoeal Disease Research, Bangladesh, Centre for Child and Adolescent Health
Locations
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International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, , Bangladesh
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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61067
Identifier Type: -
Identifier Source: org_study_id
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