Hepatitis E Infection Clinical Trial
Official title:
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.
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.
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