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

2026년 6월 2일 업데이트: Centre for Infectious Disease Research in Zambia

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.

연구 개요

연구 유형

관찰

등록 (추정된)

43

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Lusaka Province
      • Lusaka, Lusaka Province, 잠비아, P.O.BOX34681LUSAKA,ZAMBIA10101
        • 모병
        • TROPGAN
        • 연락하다:
        • 수석 연구원:
          • Paul Kelly, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of participants completing all scheduled study procedures
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Clinical Follow-up Retention Rate
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 30일

기본 완료 (추정된)

2026년 9월 30일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 7400-2025

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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