[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637908":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":45,"centralContacts":36,"locations":49,"responsibleParty":67,"collaborators":36,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":36,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":100,"whyStopped":36,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Ministry of Health, Saudi Arabia","OTHER_GOV",[8,16,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Shingrix + Semaglutide Placebo","ACTIVE_COMPARATOR","RZV 0.5 mL IM at Months 0 and 2 + subcutaneous saline placebo once weekly for 24 months. Standard-of-care insulin therapy continues throughout",[13,14,15],"Drug: Recombinant Zoster Vaccine (Shingrix; RZV)","Drug: Semaglutide (Ozempic®)","Drug: Placebo (saline injection)",{"label":17,"type":10,"description":18,"interventionNames":19},"Semaglutide + RZV Placebo","Semaglutide 0.25 mg SC weekly for 4 weeks, then 0.5 mg SC weekly for 24 months + IM saline placebo at Months 0 and 2. Standard-of-care insulin throughout.",[13,14,15],{"label":21,"type":22,"description":23,"interventionNames":24},"Shingrix + Semaglutide (Combination","EXPERIMENTAL","RZV 0.5 mL IM at Months 0 and 2 + Semaglutide 0.25 mg SC weekly (escalating to 0.5 mg) for 24 months. Standard-of-care insulin throughout. PRIMARY EXPERIMENTAL ARM.",[13,14,15],{"label":26,"type":27,"description":28,"interventionNames":29},"Double placebo","PLACEBO_COMPARATOR","IM saline placebo at Months 0 and 2 + subcutaneous saline placebo once weekly for 24 months. Standard-of-care insulin throughout",[13,14,15],[31,37,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Recombinant Zoster Vaccine (Shingrix; RZV)","Intervention 1: Recombinant Zoster Vaccine (Shingrix; RZV) Drug\u002FBiological: Recombinant zoster vaccine (lyophilized VZV glycoprotein E antigen 50 μg + AS01B adjuvant system \\[MPL 50 μg + QS-21 50 μg in liposomal formulation\\]). Dose: 0.5 mL intramuscular injection (reconstituted per manufacturer's instructions). Schedule: Two doses - Month 0 and Month 2 (8-week interval). Route: Intramuscular (deltoid, non-dominant arm preferred). Manufacturer: GlaxoSmithKline (GSK). FDA Status: Approved for herpes zoster prevention; use in T1D is investigational (IND required). Mechanism of Action: AS01B adjuvant promotes DC maturation, Th1 polarization, and regulatory T-cell induction via TLR4 (MPL) and saponin (QS-21) pathways",[26,17,21,9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Semaglutide (Ozempic®)","Drug: Semaglutide - GLP-1 receptor agonist (acylated GLP-1 analogue with 94% sequence homology to native GLP-1). Dose Escalation: 0.25 mg SC once weekly (Weeks 1-4) → 0.5 mg SC once weekly (Weeks 5-24 months). Route: Subcutaneous injection (abdomen, thigh, or upper arm; rotate sites). Manufacturer: Novo Nordisk. FDA Status: Approved for T2D; investigational use in T1D (IND required). Mechanism of Action: GLP-1 receptor agonism enhances glucose-dependent insulin secretion, inhibits glucagon, promotes beta-cell survival and proliferation, reduces ER stress, and suppresses pro-inflammatory cytokine-mediated apoptosis (IL-1β, IFN-γ, TNF-α).",[26,17,21,9],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Placebo (saline injection)","Saline placebo administered as intramuscular injection (matching RZV volume 0.5 mL) at Months 0 and 2, and\u002For as subcutaneous injection (matching semaglutide volume) once weekly for 24 months. Used in control and single-active arms to maintain blinding.",[26,17,21,9],[46],{"name":47,"affiliation":5,"role":48},"Amr Ahmed, MD, PhD","PRINCIPAL_INVESTIGATOR",[50],{"facility":51,"status":36,"city":52,"state":36,"zip":36,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ministry of Health Medical City","Riyadh","Saudi Arabia","SA",{"type":56,"coordinates":57},"Point",[58,59],46.72185,24.68773,{"lat":59,"lon":58},[62],{"name":63,"role":64,"phone":65,"phoneExt":36,"email":66},"Amr Ahmed","CONTACT","+966112124444","amr.ahmed@example.com",{"type":48,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Amr kamel khalil Ahmed","Ministry of heath, public health department, saudia arabia","100637908","phase-2-shield-t1d-shingrix-and-glp-1-agonist-for-beta-cell-preservation-in-recent-onset-type-1-diabetes-100637908",false,"NCT07614412","SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.","Recombinant Zoster Vaccine (Shingrix) and GLP-1 Receptor Agonist for the Preservation of Beta-Cell Function in Adults With Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.","SHIELD-T1D","Inclusion Criteria:\n\n1. Diagnosis of Type 1 Diabetes (T1D) according to American Diabetes Association (ADA) criteria.\n2. Age 18 to 50 years (inclusive) at the time of screening.\n3. Randomization within 100 days of the first insulin injection.\n4. Confirmed residual beta-cell function, defined as a peak stimulated C-peptide level ≥0.2 nmol\u002FL during a Mixed Meal Tolerance Test (MMTT) performed at screening.\n5. Presence of at least one T1D-related autoantibody (GADA, IA-2A, ZnT8A, or ICA).\n6. Willingness to comply with intensive insulin therapy and glucose monitoring.\n7. Females of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis (DKA) within 4 weeks of screening.\n2. Prior use of any immunotherapy or investigational agents for T1D.\n3. Current or prior use of GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors.\n4. History of pancreatitis or medullary thyroid carcinoma.\n5. Active or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis).\n6. Pregnancy or breastfeeding.\n7. Significant renal, hepatic, or cardiovascular disease.\n8. History of severe allergic reaction to any component of the Recombinant Zoster Vaccine (Shingrix) or semaglutide.\n9. Current use of systemic corticosteroids or other immunosuppressive medications.","ALL","18 Years","50 Years",{"count":82,"type":83},240,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by progressive destruction of pancreatic beta cells mediated by autoreactive T lymphocytes, resulting in absolute insulin deficiency. Preservation of residual beta-cell function at the time of diagnosis is a critical therapeutic window, as even marginal endogenous insulin secretion - reflected by detectable C-peptide levels - is associated with improved glycemic control, reduced hypoglycemia burden, and decreased long-term vascular complication rates.\n\nThis study evaluates the hypothesis that combinatorial immunomodulation - using the AS01B adjuvant system within the Recombinant Zoster Vaccine (RZV; Shingrix, GSK) alongside metabolic and cytoprotective support via a GLP-1 receptor agonist (semaglutide) - can synergistically preserve residual beta-cell function in adults within 100 days of T1D diagnosis. The AS01B adjuvant system activates innate immune pathways that promote regulatory T-cell (Treg) expansion and shift the immunological milieu toward tolerance, while GLP-1 receptor agonism provides direct beta-cell cytoprotection, reduces glucotoxicity, and may suppress autoimmune cytokine signaling.\n\nSHIELD-T1D is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial enrolling 240 adults (18-50 years) diagnosed with T1D within 100 days, with confirmed residual beta-cell function (stimulated C-peptide ≥0.2 nmol\u002FL). Participants are randomized 1:1:1:1 to one of four arms: (1) Shingrix alone, (2) Semaglutide alone, (3) Shingrix + Semaglutide combination, or (4) dual placebo. The primary endpoint is change in 2-hour stimulated C-peptide AUC during a Mixed Meal Tolerance Test (MMTT) from baseline to 12 months.\n\nThis phase II randomized, double-blind, placebo-controlled multicenter trial will evaluate the efficacy and safety of the recombinant zoster vaccine (Shingrix) and a glucagon-like peptide-1 (GLP-1) receptor agonist, alone and in combination, for preservation of residual beta-cell function in adults with recent-onset type 1 diabetes. The working hypothesis is that combining AS01 adjuvant-mediated immunomodulation with the metabolic and cytoprotective actions of a GLP-1 receptor agonist will provide dual protection for pancreatic beta cells, slowing autoimmune destruction and improving functional insulin secretion compared with placebo.",[89],"Type 1 Diabetes Mellitus",[91,92,93,94,95,96,97,98,99],"Type 1 Diabetes","Beta-cell preservation","C-peptide","GLP-1 receptor agonist","Recombinant zoster vaccine","Shingrix","AS01 adjuvant","Immunomodulation","Autoimmunity","NOT_YET_RECRUITING","2026-05-21",{"date":103,"type":104},"2026-05-29","ACTUAL",{"date":106,"type":83},"2027-01-01",{"date":108,"type":83},"2028-12-31",{"name":5,"class":6},1]