- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07626606
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Michelo Simuyandi, Post Graduate (MSc)
- Numero di telefono: +260968424794
- Email: michelo.simuyandi@cidrz.org
Backup dei contatti dello studio
- Nome: Stanley Mwale, Master's Degree (MPH)
- Numero di telefono: +260966745554
- Email: stanley.mwale@cidrz.org
Luoghi di studio
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Lusaka Province
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Lusaka, Lusaka Province, Zambia, P.O.BOX34681LUSAKA,ZAMBIA10101
- Reclutamento
- TROPGAN
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Contatto:
- Paul Kelly, PhD
- Numero di telefono: +260 211 25226 +44 7484 329970
- Email: m.p.kelly@qmul.ac.uk
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Investigatore principale:
- Paul Kelly, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of participants completing all scheduled study procedures
Lasso di tempo: Through study completion, an average of 1 year.
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The percentage of enrolled participants who complete all scheduled study visits and protocol-defined procedures.
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Through study completion, an average of 1 year.
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Sample Quality Control (QC) Success Rate
Lasso di tempo: Through study completion, an average of 1 year.
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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).
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Through study completion, an average of 1 year.
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Proportion of intestinal biopsy samples meeting predefined quality control thresholds
Lasso di tempo: Through study completion, an average of 1 year.
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The percentage of collected intestinal biopsy samples meeting predefined quality control criteria for downstream laboratory analysis, including tissue integrity and adequate sample preservation.
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Through study completion, an average of 1 year.
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Pre-analytical Sample Processing Efficiency
Lasso di tempo: Periprocedural
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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.
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Periprocedural
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinical Follow-up Retention Rate
Lasso di tempo: Through study completion, an average of 1 year.
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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.
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Through study completion, an average of 1 year.
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Regulated Gene Expression Profiles
Lasso di tempo: Baseline, and up to 52 weeks post-enrollment.
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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.
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Baseline, and up to 52 weeks post-enrollment.
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Correlation of Mucosal Spatial Transcriptomics with Systemic Immunity
Lasso di tempo: Baseline, and up to 52 weeks post-enrollment.
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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.
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Baseline, and up to 52 weeks post-enrollment.
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Michelo Simuyandi, Master's Degree (MSc), Centre for Infectious Disease Research in Zambia
Pubblicazioni e link utili
Pubblicazioni generali
- Regassa R, Tamiru D, Duguma M, Belachew T. Environmental enteropathy and its association with water sanitation and hygiene in slum areas of Jimma Town Ethiopia. PLoS One. 2023 Jun 23;18(6):e0286866. doi: 10.1371/journal.pone.0286866. eCollection 2023.
- Kang G. Success from the South: the rotavirus vaccine story and its lessons. Lancet. 2024 Jan 6;403(10421):111-116. doi: 10.1016/S0140-6736(23)02520-5. Epub 2023 Nov 28. No abstract available.
- Bein A, Fadel CW, Swenor B, Cao W, Powers RK, Camacho DM, Naziripour A, Parsons A, LoGrande N, Sharma S, Kim S, Jalili-Firoozinezhad S, Grant J, Breault DT, Iqbal J, Ali A, Denson LA, Moore SR, Prantil-Baun R, Goyal G, Ingber DE. Nutritional deficiency in an intestine-on-a-chip recapitulates injury hallmarks associated with environmental enteric dysfunction. Nat Biomed Eng. 2022 Nov;6(11):1236-1247. doi: 10.1038/s41551-022-00899-x. Epub 2022 Jun 23.
- Gu Y, Bartolome-Casado R, Xu C, Bertocchi A, Janney A, Heuberger C, Pearson CF, Teichmann SA, Thornton EE, Powrie F. Immune microniches shape intestinal Treg function. Nature. 2024 Apr;628(8009):854-862. doi: 10.1038/s41586-024-07251-0. Epub 2024 Apr 3.
- Bhattacharjee A, Burr AHP, Overacre-Delgoffe AE, Tometich JT, Yang D, Huckestein BR, Linehan JL, Spencer SP, Hall JA, Harrison OJ, Morais da Fonseca D, Norton EB, Belkaid Y, Hand TW. Environmental enteric dysfunction induces regulatory T cells that inhibit local CD4+ T cell responses and impair oral vaccine efficacy. Immunity. 2021 Aug 10;54(8):1745-1757.e7. doi: 10.1016/j.immuni.2021.07.005. Epub 2021 Aug 3.
- Kummerlowe C, Mwakamui S, Hughes TK, Mulugeta N, Mudenda V, Besa E, Zyambo K, Shay JES, Fleming I, Vukovic M, Doran BA, Aicher TP, Wadsworth MH 2nd, Bramante JT, Uchida AM, Fardoos R, Asowata OE, Herbert N, Yilmaz OH, Kloverpris HN, Garber JJ, Ordovas-Montanes J, Gartner ZJ, Wallach T, Shalek AK, Kelly P. Single-cell profiling of environmental enteropathy reveals signatures of epithelial remodeling and immune activation. Sci Transl Med. 2022 Aug 31;14(660):eabi8633. doi: 10.1126/scitranslmed.abi8633. Epub 2022 Aug 31.
- Marie C, Ali A, Chandwe K, Petri WA Jr, Kelly P. Pathophysiology of environmental enteric dysfunction and its impact on oral vaccine efficacy. Mucosal Immunol. 2018 Sep;11(5):1290-1298. doi: 10.1038/s41385-018-0036-1. Epub 2018 Jul 9.
- Li H, Wu H, Ma W, Li S, Cai J, Lin Y, Zhang J, Wang Y, Zhang C. Spatial transcriptomics: a bibliometric analysis with large language model on English literatures. Brief Bioinform. 2025 Aug 31;26(5):bbaf553. doi: 10.1093/bib/bbaf553.
- Tan J, Taitz J, Sun SM, Langford L, Ni D, Macia L. Your Regulatory T Cells Are What You Eat: How Diet and Gut Microbiota Affect Regulatory T Cell Development. Front Nutr. 2022 Apr 20;9:878382. doi: 10.3389/fnut.2022.878382. eCollection 2022.
- Furusawa Y, Obata Y, Fukuda S, Endo TA, Nakato G, Takahashi D, Nakanishi Y, Uetake C, Kato K, Kato T, Takahashi M, Fukuda NN, Murakami S, Miyauchi E, Hino S, Atarashi K, Onawa S, Fujimura Y, Lockett T, Clarke JM, Topping DL, Tomita M, Hori S, Ohara O, Morita T, Koseki H, Kikuchi J, Honda K, Hase K, Ohno H. Commensal microbe-derived butyrate induces the differentiation of colonic regulatory T cells. Nature. 2013 Dec 19;504(7480):446-50. doi: 10.1038/nature12721. Epub 2013 Nov 13.
- Atarashi K, Tanoue T, Shima T, Imaoka A, Kuwahara T, Momose Y, Cheng G, Yamasaki S, Saito T, Ohba Y, Taniguchi T, Takeda K, Hori S, Ivanov II, Umesaki Y, Itoh K, Honda K. Induction of colonic regulatory T cells by indigenous Clostridium species. Science. 2011 Jan 21;331(6015):337-41. doi: 10.1126/science.1198469. Epub 2010 Dec 23.
- Mowat AM, Agace WW. Regional specialization within the intestinal immune system. Nat Rev Immunol. 2014 Oct;14(10):667-85. doi: 10.1038/nri3738. Epub 2014 Sep 19.
- Church JA, Rukobo S, Govha M, Gough EK, Chasekwa B, Lee B, Carmolli MP, Panic G, Giallourou N, Ntozini R, Mutasa K, McNeal MM, Majo FD, Tavengwa NV, Swann JR, Moulton LH, Kirkpatrick BD, Humphrey JH, Prendergast AJ. Associations between biomarkers of environmental enteric dysfunction and oral rotavirus vaccine immunogenicity in rural Zimbabwean infants. EClinicalMedicine. 2021 Nov 15;41:101173. doi: 10.1016/j.eclinm.2021.101173. eCollection 2021 Nov.
- Naylor C, Lu M, Haque R, Mondal D, Buonomo E, Nayak U, Mychaleckyj JC, Kirkpatrick B, Colgate R, Carmolli M, Dickson D, van der Klis F, Weldon W, Steven Oberste M; PROVIDE study teams; Ma JZ, Petri WA Jr. Environmental Enteropathy, Oral Vaccine Failure and Growth Faltering in Infants in Bangladesh. EBioMedicine. 2015 Sep 25;2(11):1759-66. doi: 10.1016/j.ebiom.2015.09.036. eCollection 2015 Nov.
- Hossain MS, Begum SMKN, Rahman MM, Parvez M, Mazumder RN, Sarker SA, Hasan MM, Fahim SM, Gazi MA, Das S, Mahfuz M, Ahmed T. Environmental enteric dysfunction and small intestinal histomorphology of stunted children in Bangladesh. PLoS Negl Trop Dis. 2023 Jan 19;17(1):e0010472. doi: 10.1371/journal.pntd.0010472. eCollection 2023 Jan.
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 7400-2025
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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