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

NCT02759991 | Completed Phase 4 DMC

• 1 other identifier: 61067
• Study Type: interventional
• Target: 19,460
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis E Infection

Keywords

Hepatitis E virus; Viral Hepatitis Vaccines

Outcome Measures

Primary Outcomes (1)

• Effectiveness of HEV vaccine in preventing HEV diseases among women in Bangladesh

  To determine the effectiveness of hepatitis E virus (HEV) vaccine in preventing HEV disease during pregnancy among women in rural Bangladesh

  2 years

Secondary Outcomes (6)

• To determine the safety of HEV vaccine in Bangladeshi women of childbearing age

  2 years

• To determine the immunogenicity of HEV vaccine in Bangladeshi women of childbearing age

  2 years

• Effectiveness of HEV vaccine in preventing HEV disease in non-pregnant Bangladeshi women of childbearing age

  2 years

• Estimate serological correlates of protection

  2 years

• Assess the feasibility, acceptability and cost-effectiveness of HEV vaccination of women of childbearing age in rural Bangladesh

  2 years

Study Arms (2)

HEV vaccine

ACTIVE COMPARATOR

Hecolin, 0.6 ml intramuscular injection day 0, 1 month and 6 months.

Drug: Hecolin

HBV vaccine

PLACEBO COMPARATOR

Hepa-B, 1 ml intramuscular injection day 0, 1 month and 6 months.

Drug: Hepa-B

Interventions

Hecolin DRUG

0.6ml Hecolin vaccine im. on day 0, 1 month and 6 months.

Also known as: HEV 239

HEV vaccine

Hepa-B DRUG

1ml Hepa-B vaccine im. on day 0, 1 month and 6 months.

Also known as: Hepatitis B virus (HBV) vaccine

HBV vaccine

Eligibility Criteria

• Age: 16 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged 16-39 years
• Living in Matlab area

You may not qualify if:

• Pregnancy
• Allergic to vaccine components
• Serious chronic diseases
• Acute illness

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (5)

• 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.

  PMID: 40733519 DERIVED

• 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.

  PMID: 39030061 DERIVED

• 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.

  PMID: 39030060 DERIVED

• 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.

  PMID: 36599736 DERIVED

• 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.

  PMID: 31959609 DERIVED

MeSH Terms

Interventions

hecolin; Hepatitis B Vaccines; Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Biological Products; Complex Mixtures

Study Officials

• Susanne Dudman, MD, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

• K Zaman, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh, Centre for Child and Adolescent Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 1. Pilot study completed in 2017 with 100 participants, 50 women and 50 men aged 16-39, randomized to be vaccinated with either 2 doses of Hecolin or Hepa-B. These 100 participants are not included in the main trial. 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.

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: May 3, 2016
• Study Start: October 2, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 15, 2024

Record last verified: 2020-10

Locations

BA (1)