Evidence map›Paper›PMID 42414915›Full record

ArticleBMC infectious diseases2026

Hepatitis E virus seroprevalence in South Africa: a multi-site study among HIV-negative and HIV-positive adults and age-stratified children (2-17 Years).

Tarun Saluja, Nigus Telele, Elizabeth Hellström, Essack Mitha, Maphoshane Nchabeleng, Rita Baiden, Naveena Aloysia D'Cor, Sridhar Vemula, Ju Yeon Park, Lei Yang and 7 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06306196 (A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children), which is not on this map. Not yet cited in PubMed.

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

What it found

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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.

NCT06306196 phase2recruitingnot on this map

A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children

TypeinterventionalSponsorInternational Vaccine InstituteRan2024 to 2026Enrolled1,040ConditionsHepatitis E Virus InfectionArmsHecolin® Recombinant Hepatitis E Vaccine, Isotonic Sodium Chloride injection
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Tarun SalujaInternational Vaccine Institute, Seoul, Republic of Korea.
Nigus TeleleInternational Vaccine Institute, Europe Regional Office, Stockholm, Sweden. nigus.telele@ivi.int.ORCID https://orcid.org/0000-0002-9795-8869
Elizabeth HellströmBe Part Research, Mbekweni, Paarl, Western Cape, South Africa.
Essack MithaNewtown Clinical Research Centre, Johannesburg, South Africa.
Maphoshane NchabelengMecru Clinical Research Unit, Department of Microbiological Pathology, National Health Laboratory Service, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
Rita BaidenInternational Vaccine Institute, Seoul, Republic of Korea.
Naveena Aloysia D'CorInternational Vaccine Institute, Seoul, Republic of Korea.
Sridhar VemulaInternational Vaccine Institute, Seoul, Republic of Korea.
Ju Yeon ParkInternational Vaccine Institute, Seoul, Republic of Korea.
Lei YangInternational Vaccine Institute, Seoul, Republic of Korea.
Jiyoung LeeInternational Vaccine Institute, Seoul, Republic of Korea.
Deok Ryun KimInternational Vaccine Institute, Seoul, Republic of Korea.
Sunju ParkInternational Vaccine Institute, Seoul, Republic of Korea.
Sanet AspinallArdent Consulting (Pty) Ltd, Cape Town, South Africa.
HuiRong PanXiamen Innovax Biotech Co., Ltd., Xiamen, China.
J Wai-Kuo ShihXiamen Innovax Biotech Co., Ltd., Xiamen, China.
Julia A LynchInternational Vaccine Institute, Seoul, Republic of Korea.

Funding

Bill and Melinda Gates Foundation Investment ID INV-061662
6 · The paper itself

Abstract

backgroundHepatitis E virus (HEV) seroprevalence varies by age and geography. Data on HEV seroprevalence across age groups and among people living with HIV (PLWH) in South Africa is scarce.

methodsWe conducted a prospective multi-site assessment of anti-HEV IgG seroprevalence on 859 South African participants enrolled at three clinical research centres including Newtown Clinical Research Centre in Johannesburg, Be Part Research in Mbekweni, Western Cape, and Mecru Clinical Research Unit in Garankuwa, Pretoria. Participants comprised adults aged 18-45 years (PLWH, n = 178 and HIV-negative, n = 232), and children aged 2-17 years (n = 449). Anti-HEV IgG serostatus and antibody titer were measured using a commercial ELISA kit and a WHO reference standard. Seroprevalence was assessed by site, age group, sex, and HIV status.

resultsOverall anti-HEV IgG seroprevalence was 18.0% (95% CI: 15.6-20.8). Adults had the highest seroprevalence (27.3% among all adults; 29.2% among PLWH and 25.9% in HIV-negative adults), while adolescents aged 12-17 years had the lowest (6.9%), and young children aged 6-11 years and 2-5 years had 10.3% and 13.0%, respectively. Adults had significantly higher odds of seropositivity than children (aOR 2.8, 95% CI: 1.5-5.5, p = 0.002). A significant site-specific variation was also observed among healthy adults and adolescents: Newtown Clinical Research Centre (23.0% and 14.0%) and Be Part Research (34.5% and 7.3%) had higher seroprevalence compared with those from Mecru Clinical Research Unit (17.2% and 1.5%, p = 0.0499 and 0.0262, respectively). Higher mean antibody titer observed in younger children aged 2-5 years (5.06 IU/mL), compared with adults (0.88 IU/mL among PLWH and 0.68 IU/mL among HIV-negative adults), and older children (2.02 IU/mL in those aged 6-11 years and 0.67 IU/mL in those aged 12-17 years).

conclusionsHEV seroprevalence in South Africa was highly heterogeneous, varying markedly by age group and study site. These findings highlight the need for strengthened, integrated HEV surveillance to better define transmission patterns and to inform evidence-based considerations for prevention of infection.

trial registrationClinicalTrials.gov: NCT06306196; Registration date: 2024-02-18. South African National Clinical Trials Register (SANCTR): DOH-27-032024-8165; Registration Date 2024-03-04.

Indexed as

Hepatitis AntibodiesHepatitis EHepatitis E virusHIV InfectionsAdolescentAdultAge FactorsChildChild, PreschoolFemaleHumansImmunoglobulin GMaleMiddle AgedProspective StudiesSeroepidemiologic StudiesHepatitis AntibodiesImmunoglobulin GAdultsAntibody titersChildrenHEVHIVMulti-siteSeroprevalenceSouth Africa

Identifiers

PMID42414915
PMCPMC13348455

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Registered trials

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