HEV vaccine trial results published in Lancet
Hepatitis E virus (HEV) infection is prevalent around the world, especially affecting low-income countries in Asia and Africa. High morbidity and mortality have been reported in pregnant women and their children. The only licensed vaccine against HEV, the recombinant HEV239, has been used in a large RCT in Bangladesh. The results from the clinical trial were published in Lancet recently. Senior author is Susanne G. Dudman, head of the The Clinical Virology Research Group group at the Department of Microbiology.
Summary from the authors:
Results from an effectiveness trial to evaluate protection of pregnant women by a HEV vaccine in Bangladesh
We conducted a large phase 4, double-blind, cluster-randomised trial in 67 villages in Matlab, Bangladesh, and hereby share some of our results. Between 2017 and2021, 19 460 participants were randomised to receive HEV239, a recombinant hepatitis E virus (HEV) vaccine or a control vaccine (Hepa-B, a hepatitis B vaccine). Both groups received three doses of the vaccine at 0, 1, and 6 months, and were extensively followed for two years after the last dose to detect pregnancy, monitor the pregnancy outcome and to detect the HEV infection in both the pregnant and non-pregnant population.
HEV was not detected among pregnant women, but six HBV recipients experienced HEV in the non-pregnant population. Solicited adverse events were mild and HEV239 was well tolerated. Pain at injection site was the most common local reaction, observed at similar rate for both HEV239 and HBV vaccines. No serious adverse events were deemed to be vaccine related.
Furthermore, among pregnant participants, the HEV239 group exhibited a higher risk of miscarriage (5·7%) compared with the control group (3·9%), irrespective of the timing of vaccine in relation to pregnancy onset. This observation was further investigated in a concurrently published article by Asma Aziz and colleagues, which confirmed that HEV239 was linked to an increased risk of miscarriage when administered shortly before or during pregnancy.
More details can be found in the open access article online:
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, 12 (8), e1288-e1299
DOI 10.1016/S2214-109X(24)00192-X, PubMed 39030060
Links:
ClinVir – Clinical Virology Research Group
Susanne G. Dudman - mini CV and publications
Hepatitis e infection is caused by hepatitis e virus that attacks lives and provides liver inflammation:
