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

October 7, 2020 updated by: Norwegian Institute of Public Health

An Effectiveness Trial (Phase IV) to Evaluate Protection of Pregnant Women by Hepatitis E Virus (HEV) Vaccine in Bangladesh and Risk Factors for Severe HEV Infection.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis E virus (HEV) infection is endemic in Bangladesh, causing severe or fatal complications in pregnant women. This GLOBVAC funded project aims to assess the safety, feasibility, acceptability, immunogenicity, effectiveness, and cost-effectiveness of the HEV vaccine (Hecolin, Innovax, China) when given women of childbearing age in a rural area in Bangladesh (Matlab). The vaccine has been shown to be both effective and safe in the general adult population in China, but there is insufficient data about its efficacy among pregnant women, the group with most to gain from vaccination.

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.

Study Type

Interventional

Enrollment (Actual)

19460

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HEV vaccine
Hecolin, 0.6 ml intramuscular injection day 0, 1 month and 6 months.
Drug: Hecolin
0.6ml Hecolin vaccine im. on day 0, 1 month and 6 months.
Other Names:
  • HEV 239
Placebo Comparator: HBV vaccine
Hepa-B, 1 ml intramuscular injection day 0, 1 month and 6 months.
Drug: Hepa-B
1ml Hepa-B vaccine im. on day 0, 1 month and 6 months.
Other Names:
  • Hepatitis B virus (HBV) vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of HEV vaccine in preventing HEV diseases among women in Bangladesh
Time Frame: 2 years
To determine the effectiveness of hepatitis E virus (HEV) vaccine in preventing HEV disease during pregnancy among women in rural Bangladesh
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the safety of HEV vaccine in Bangladeshi women of childbearing age
Time Frame: 2 years
Number of participants with adverse events related to vaccination as assessed by CTCAE v4.0
2 years
To determine the immunogenicity of HEV vaccine in Bangladeshi women of childbearing age
Time Frame: 2 years
Number of participants who seroconvert after three doses
2 years
Effectiveness of HEV vaccine in preventing HEV disease in non-pregnant Bangladeshi women of childbearing age
Time Frame: 2 years
To determine the effectiveness of hepatitis E virus (HEV) vaccine in preventing HEV disease in participants
2 years
Estimate serological correlates of protection
Time Frame: 2 years
Assess the anti-HEV IgG levels before and one month after the last dose of vaccine for primary vaccine response and record if any HEV disease occurs.
2 years
Assess the feasibility, acceptability and cost-effectiveness of HEV vaccination of women of childbearing age in rural Bangladesh
Time Frame: 2 years
Analyse cost per disability, adjusted life year and quality adjusted life year
2 years
Investigate acute HEV cases virologically, clinically and immunologically in relation to outcome.
Time Frame: 2 years
Examine acute HEV cases in relation to severity of illness and immunological responses
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh
Sykehuset Innlandet HF

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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