Evidence map›Paper›PMID 39424575›Full record

ArticleThe Lancet. Global health2024

Safety of hepatitis E vaccine in pregnancy: an emulated target trial following a mass reactive vaccination campaign in Bentiu internally displaced persons camp, South Sudan.

Robin C Nesbitt, Andrew S Azman, Vincent Kinya Asilaza, Jessie K Edwards, Priscillah Gitahi, Patrick Nkemenang, Jetske Duncker, Melat Haile, Primitive Gakima, Joseph F Wamala and 8 more

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet. Global health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
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  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Robin C NesbittEpicentre, Paris, France. Electronic address: robin.nesbitt@epicentre.msf.org.
Andrew S AzmanMédecins Sans Frontières, Geneva, Switzerland; Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA; Geneva Centre for Emerging Viral Diseases and Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Geneva, Switzerland.
Vincent Kinya AsilazaMédecins Sans Frontières, Juba, South Sudan.
Jessie K EdwardsUniversity of North Carolina, Chapel Hill, NC USA.
Priscillah GitahiMédecins Sans Frontières, Juba, South Sudan.
Patrick NkemenangMédecins Sans Frontières, Juba, South Sudan.
Jetske DunckerMédecins Sans Frontières, Juba, South Sudan.
Melat HaileMédecins Sans Frontières, Geneva, Switzerland.
Primitive GakimaMédecins Sans Frontières, Geneva, Switzerland.
Joseph F WamalaWorld Health Organization, Juba, South Sudan.
Fredrick Beden LoroWorld Health Organization, Juba, South Sudan.
Duol BiemMinistry of Health, Juba, South Sudan.
Nelly StaderiniMédecins Sans Frontières, Geneva, Switzerland.
Manuel AlbelaMédecins Sans Frontières, Geneva, Switzerland.
Monica RullMédecins Sans Frontières, Geneva, Switzerland.
John RumunuMinistry of Health, Juba, South Sudan.
Iza CigleneckiMédecins Sans Frontières, Geneva, Switzerland.
Etienne GignouxEpicentre, Paris, France.

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundEpidemic forms of hepatitis E cause high mortality among pregnant people, with case fatality risks over 30% and adverse fetal outcomes. In 2022, the first mass reactive vaccination campaign against hepatitis E was conducted in South Sudan with the HEV239 vaccine. We aimed to assess whether vaccination against hepatitis E in pregnancy increases the risk of fetal loss in a cohort of vaccinated and unvaccinated pregnant people.

methodsIn this emulated target trial, an exhaustive pregnancy census was conducted in Bentiu internally displaced persons camp after the second of three vaccination rounds. Women and girls aged 14-45 years with no current jaundice or acute illness were eligible for participation. Individuals who consented were revisited 28 days after their delivery date to document the pregnancy outcome. We used an emulated target trial framework to address biases inherent in observational studies. We matched vaccinated to unvaccinated participants on age, gestational age, and vaccination propensity score and estimated cumulative incidence functions for fetal loss in vaccinated compared to unvaccinated women in a competing risks framework using the Aalen-Johansen estimator.

findingsBetween May 16 and June 30, 2022, 3421 participants were enrolled and followed up for inclusion in analysis. Among 2741 women who had a pregnancy outcome after the start of the vaccination campaign, 67 (2·4%) were vaccinated before conception, 2036 (74·3%) were vaccinated during pregnancy, and 638 (23·2%) were not vaccinated. Among the 2407 women retained in the matched analyses, the cumulative risk of fetal loss among individuals vaccinated during pregnancy was 7·2% (95% CI 5·6-8·7) compared with 6·1% (3·7-9·2) among unvaccinated individuals, implying a risk ratio of 1·2 (95% CI 0·7-1·9).

interpretationNo evidence of increased risk of fetal loss was found among individuals vaccinated during pregnancy.

fundingMédecins Sans Frontières.

Indexed as

Hepatitis EMass VaccinationViral Hepatitis VaccinesAdolescentAdultFemaleHumansMiddle AgedPregnancyPregnancy Complications, InfectiousPregnancy OutcomeRefugee CampsRefugeesSouth SudanYoung AdultViral Hepatitis Vaccines

Identifiers

PMID39424575
PMCPMC11483246

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.