{"type":"trials","record":{"id":21634,"source_id":"clinicaltrials-gov","external_id":"NCT05421546","title":"Improving Vaccination in Older Adults by Inducing Autophagy With Spermidine","brief_summary":"Easing the morbidity and economic burden of age-related diseases is one of the major medical challenges. One of the key obstacles to healthy ageing is immune senescence, including the failure of lymphocytes to respond adequately to infection, malignancy and vaccination. Infectious diseases remain the fourth most common cause of death among the elderly in the developed world. Moreover, the gain of chronic low-grade non-specific inflammation with age contributes to many age-related diseases. Our early work showed that autophagy, the main cellular bulk degradation pathway in the cell, prevents ageing of the immune system. In preclinical models we showed an age-related decline in T cell autophagy. We rejuvenated the immune system by restoring autophagy in T and B cells with the autophagy-inducing metabolite spermidine. Here we are asking for matched funds for a small human clinical trial to confirm that spermidine has the same effect when administered to humans. We will give the nutraceutical spermidine to human volunteers aged \\>65 years either during or after vaccination against SARS-CoV-2 or influenza to test improvement of vaccine responses, immune senescence and inflamm-aging. We will also confirm whether a novel pathway we discovered that links spermidine to autophagy operates in humans, allowing us to make more specific drugs in the future. This small study of 120 volunteers overall will pave the way for a larger clinical trial with spermidine or novel related drugs.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Oxford","enrollment":40,"countries":["United Kingdom"],"start_date":"2022-08-01","completion_date":"2023-12-02","last_update_date":"2024-05-09","source_url":"https://clinicaltrials.gov/study/NCT05421546","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:08.26846+00:00","last_seen_at":"2026-09-25T06:05:50.347+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years to 90 Years","comparator":"Spermidine arm; Placebo arm","organization":"University of Oxford","interventions":["Spermidine or Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The primary objective of this study is to determine the safety of daily Spermidine supplements following the vaccine bo…","Our secondary objective is to determine the effects of daily Spermidine supplements on the immune 'memory' response to…"],"design_description":"RANDOMIZED · PARALLEL · BASIC SCIENCE · TRIPLE","source_has_results":false},"controlled_terms":["COVID-19","Vaccine Reaction","Spermidine or Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: spermidine.","quality_checked_at":"2026-09-25T06:05:50.754264+00:00","duplicate_cluster_key":"id:nct05421546","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-08-01 to 2023-12-02","comparator":"Spermidine arm; Placebo arm","confidence":"structured-source","population":"ALL · 65 Years to 90 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:05:50.350Z","intervention":["Spermidine or Placebo"],"participants":40,"study_design":"RANDOMIZED · PARALLEL · BASIC SCIENCE · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["The primary objective of this study is to determine the safety of daily Spermidine supplements following the vaccine bo…","Our secondary objective is to determine the effects of daily Spermidine supplements on the immune 'memory' response to…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"autophagy","is_published":true,"match_reasons":["Title contains controlled term: autophagy.","Abstract contains controlled term: autophagy.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Autophagy","slug":"autophagy"}},{"topic_slug":"spermidine","is_published":true,"match_reasons":["Title contains controlled term: spermidine.","Abstract contains controlled term: spermidine.","Source terminology contains: spermidine.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Spermidine","slug":"spermidine"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21634","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}