[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaccine-immune-response\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaccine-immune-response":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100637308","how-gut-health-affects-immune-responses-to-the-oral-rotavirus-vaccine-in-adults-in-zambia-100637308",false,"NCT07626606","How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia","Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy","Rota-Omics","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 50 years.\n* Able and willing to provide written informed consent.\n* Reside within Lusaka district and available for scheduled follow-up.\n* Willing to undergo two endoscopy procedures with serial sample collection.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).\n* Known severe immunodeficiency (HIV with CD4 \\\u003C 200 cells\u002Fmm³, current cancer chemotherapy, systemic corticosteroids equivalent to \\>20 mg\u002Fday prednisolone for \\>2 weeks).\n* Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).\n* Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.\n* Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration.\n* Any condition judged by the investigator to compromise participant safety or data integrity.\n* 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.\n\nPregnancy 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.",true,"ALL","18 Years","50 Years",{"count":22,"type":23},43,"ESTIMATED","OBSERVATIONAL","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.\n\nA 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.\n\nThe 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.\n\nThe 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.\n\nOne 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.\n\nThe 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.\n\nIn 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.\n\nOverall, 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.",[27,28,29,30],"Feasibility Study","Vaccine Immune Response","Rota Virus Gastroenteritis","Transcriptomics",[30,32,33,34,35,36],"Feasibility","Microbiome","Immunity","Rotavirus","Vaccine","RECRUITING","2026-06-02",{"date":40,"type":41},"2026-06-04","ACTUAL",{"date":43,"type":41},"2026-03-30",{"date":45,"type":23},"2026-12-31",{"name":47,"class":48},"Centre for Infectious Disease Research in Zambia","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100637138","phase-2-vaccination-response-modulation-with-a-targeted-rapamycin-protocol-study-100637138","NCT07587801","Vaccination Response Modulation With a Targeted Rapamycin Protocol Study","Vaccination Response Modulation With a Targeted Rapamycin Protocol (VON TRAPP) Study","VON TRAPP","Inclusion Criteria:\n\n* End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy\n* Aged \\>60 years\n\nExclusion Criteria:\n\n* Aged \\\u003C60 years\n* Alternative haemodialysis regimens (e.g. twice-weekly haemodialysis, second-daily home haemodialysis)\n* Recent infection (\\\u003C6 months) with proven Influenza A, Influenza B, or RSV\n* Current use of immunosuppressive medications, including:\n\n  * Oral steroid at a dose equivalent of 5 mg\u002Fday prednisolone or greater\n  * Mycophenolate mofetil\n  * Azathioprine\n  * Calcineurin inhibitors\n  * mTOR inhibitors\n* Recent use of intravenous immunosuppressive medications (\\\u003C6 months), including:\n\n  * T-cell depleting agents (e.g. anti-thymocyte globulin)\n  * B-cell depleting agents (e.g. rituximab)\n  * Cyclophosphamide\n* Has a history of problems with side-effects associated with sirolimus use including\n\n  * Angioedema\n  * Active\u002Frecent opportunistic infection\n  * Current or prior interstitial lung disease, non-infectious pneumonitis, organising pneumonia, or pulmonary fibrosis\n  * Clinically significant pleural effusion or pericardial effusion\n  * Active non-healing wounds, chronic skin ulcers, or planned major surgery\u002Fprocedures\n  * Current malignancy or recent malignancy with high recurrence risk\n  * Severe or uncontrolled hyperlipidaemia\n  * History of rhabdomyolysis\n  * Severe hepatic impairment\n* Ongoing use of strong CYP3A4\u002FP-gp inhibitors or inducers including\n\n  * Inhibitors: Ketoconazole, Voriconazole, Itraconazole, Telithromycin, Clarithromycin\n  * Inducers: Rifampicin, Rifabutin\n* Unable or unwilling to provide informed consent to participate in the trial\n* Known allergy to or intolerance of sirolimus (rapamycin) or the contents of the influenza or RSV vaccine","60 Years",{"count":60,"type":23},60,"INTERVENTIONAL",[63],"PHASE2","This study will investigate dialysis recipients' responses to important vaccines.\n\nResearch suggests that a medication commonly used by transplant recipients may improve vaccine responses. The investigators will be conducting a clinical trial to see whether a short course of low-dose Sirolimus improves the response to vaccination against respiratory syncytial virus (RSV) and influenza (flu) in patient with kidney disease over 60 years old who receive haemodialysis.",[28,66,67],"Haemodialysis Patients","Older Adults",[69,70,71,72,73,74],"influenza","RSV","vaccine","haemodialysis","older adults","immunosenescence","NOT_YET_RECRUITING","2026-05-11",{"date":78,"type":41},"2026-05-14",{"date":80,"type":23},"2026-05",{"date":82,"type":23},"2026-07",{"name":84,"class":85},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",3]