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How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia (Rota-Omics)

Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy

The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally.

A major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resource settings. EE is associated with damage to the intestinal lining, chronic immune activation, poor nutrient absorption, and impaired gut barrier function. These changes are thought to interfere with the body's ability to respond effectively to oral vaccines, which rely on strong intestinal immune responses.

The RotaOmics study uses a systems biology approach to investigate how the immune system, gut microbiome, nutrition, and intestinal inflammation interact to influence rotavirus vaccine responses. The term "omics" refers to advanced technologies that allow researchers to study genes, proteins, microbes, and other biological processes at a large scale. By combining these approaches, the study aims to identify biological markers and immune pathways associated with strong or weak vaccine responses.

The study involves the collection of samples such as blood, stool, saliva, and breast milk from mothers and infants at different time points before and after vaccination. These samples are analysed using laboratory methods including antibody testing, molecular pathogen detection, microbiome sequencing, and immune profiling. The study also evaluates markers of gut inflammation and intestinal health.

One important goal of the project is to identify correlates of protection, which are measurable biological indicators that predict whether a vaccine is likely to protect against disease. Identifying these markers could help guide the development of improved vaccines or supportive interventions to enhance vaccine performance in vulnerable populations.

The study also contributes to a broader understanding of mucosal immunity, which refers to immune responses occurring in the gastrointestinal tract. Since many enteric infections begin in the gut, understanding intestinal immune function is important not only for rotavirus vaccines but also for other oral vaccines and diarrheal diseases.

In addition to its scientific objectives, RotaOmics includes a strong capacity-building component. The project supports training for local scientists, clinicians, and laboratory personnel in areas such as molecular biology, immunology, genomics, bioinformatics, and data analysis. By strengthening local research expertise and infrastructure, the study aims to support long-term scientific development and improve regional capacity for infectious disease research and outbreak response.

Overall, the RotaOmics study seeks to generate new insights into why oral rotavirus vaccines underperform in some settings and to identify strategies that may improve vaccine effectiveness and child health outcomes in Zambia and similar regions worldwide.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Anslået)

43

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Lusaka Province
      • Lusaka, Lusaka Province, Zambia, P.O.BOX34681LUSAKA,ZAMBIA10101
        • Rekruttering
        • TROPGAN
        • Kontakt:
        • Ledende efterforsker:
          • Paul Kelly, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Healthy adults living in Chawama, a densely populated peri-urban setting in proximity to the study recruitment site.

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 50 years.
  • Able and willing to provide written informed consent.
  • Reside within Lusaka district and available for scheduled follow-up.
  • Willing to undergo two endoscopy procedures with serial sample collection.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).
  • Known severe immunodeficiency (HIV with CD4 < 200 cells/mm³, current cancer chemotherapy, systemic corticosteroids equivalent to >20 mg/day prednisolone for >2 weeks).
  • Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).
  • Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.
  • Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration.
  • Any condition judged by the investigator to compromise participant safety or data integrity.
  • Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier.

Pregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Consenting healthy adult Participants aged ≥ 18 years and ≤ 50 years
Participants will receive a double oral Rotarix dose at baseline. Serial duodenal biopsies will be collected from predefined subgroups to capture early, mid, and late mucosal responses while minimizing per-participant invasive procedures (the sparse sampling design allows construction of profiles of responses over 4 time points while no individual participant undergoes more than 2 endoscopies). The study design avoids confounding from placebo-related procedural differences and allows for robust within-subject longitudinal comparisons.
This is an infant vaccine, but this study participants in this study will receive a double oral Rotarix dose at baseline as per study design.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants completing all scheduled study procedures
Tidsramme: Through study completion, an average of 1 year.
The percentage of enrolled participants who complete all scheduled study visits and protocol-defined procedures.
Through study completion, an average of 1 year.
Sample Quality Control (QC) Success Rate
Tidsramme: Through study completion, an average of 1 year.
The proportion of tissue biopsies that successfully meet the defined technical quality control thresholds required for spatial transcriptomic (ST) processing (e.g., RNA integrity number, tissue structural preservation, and spot sequencing depth).
Through study completion, an average of 1 year.
Proportion of intestinal biopsy samples meeting predefined quality control thresholds
Tidsramme: Through study completion, an average of 1 year.
The percentage of collected intestinal biopsy samples meeting predefined quality control criteria for downstream laboratory analysis, including tissue integrity and adequate sample preservation.
Through study completion, an average of 1 year.
Pre-analytical Sample Processing Efficiency
Tidsramme: Periprocedural
The precise duration of time (measured in minutes) recorded from the exact moment of clinical biopsy collection to the successful snap-freezing/cryopreservation of the tissue sample.
Periprocedural

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Follow-up Retention Rate
Tidsramme: Through study completion, an average of 1 year.
The percentage of enrolled study participants who successfully complete all scheduled follow-up clinical visits and specimen collection time points as per the study protocol.
Through study completion, an average of 1 year.
Regulated Gene Expression Profiles
Tidsramme: Baseline, and up to 52 weeks post-enrollment.
Identification of differentially expressed genes and pathway spatial modules within histologically mapped regions of interest (ROIs) on Hematoxylin and Eosin-stained tissue architectures, analysed via spatially aware linear mixed-effects models.
Baseline, and up to 52 weeks post-enrollment.
Correlation of Mucosal Spatial Transcriptomics with Systemic Immunity
Tidsramme: Baseline, and up to 52 weeks post-enrollment.
The statistical relationship (evaluated using Spearman rank correlation coefficients) between tissue-based spatial gene module scores and external serologic or stool-based mucosal immune biomarkers, adjusted for age, sex, and baseline environmental enteric dysfunction (EED) markers.
Baseline, and up to 52 weeks post-enrollment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Michelo Simuyandi, Master's Degree (MSc), Centre for Infectious Disease Research in Zambia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. marts 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7400-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Due to requirements of the ethics committee, the study is not permitted to share individual participant data unless otherwise requested for and approved by the University of Zambia Biomedical Research Ethics Committee.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Vaccine immunrespons

Kliniske forsøg med Rotarix®,

Abonner