[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaccine-response\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaccine-response":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100564926","impact-of-kidney-failure-on-the-regulation-of-humoral-response-to-vaccination-100564926",false,"NCT06635525","Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination","Tfh-CKD","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Patients undergoing thrice-weekly hemodialysis \u002F peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency\n* Subjects eligible to receive a seasonal influenza vaccine\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* Recent influenza infection (clinically resolved less than 3 months ago).\n* Administration of immunosuppressive drugs in the two weeks prior to vaccination.\n* Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation).\n* Systemic infection clinically resolved less than two weeks before enrollment.",true,"ALL","18 Years","70 Years",{"count":21,"type":22},146,"ESTIMATED","OBSERVATIONAL","The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.\n\nResearchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.\n\nParticipants will:\n\n* Be enrolled at the time of influenza vaccination\n* Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination\n* Be asked to provide relevant clinical information and a blood sample at each visit",[26,27],"Chronic Kidney Disease Requiring Chronic Dialysis","Vaccine Response",[29,30,31,32,33,34],"Vaccine","Influenza","Chronic Kidney Disease","Hemodialysis","Peritoneal dialysis","Humoral Response","RECRUITING","2026-03-25",{"date":38,"type":39},"2026-03-30","ACTUAL",{"date":41,"type":39},"2024-10-16",{"date":43,"type":22},"2026-07",{"name":45,"class":46},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100579192","phase-1-thymalfasin-thymosin-alpha-1-ta1-as-an-enhancer-of-vaccine-response-among-older-adults-receiving-booster-doses-of-covid-19-vaccine-100579192","NCT06821100","Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine","Inclusion Criteria\n\nSubjects who meet all of the following criteria will be eligible to participate in the study:\n\n1. Age 65 or greater.\n2. Able and willing to provide informed consent or have consent provided by a legally authorized representative (LAR).\n3. Scheduled for SARS-CoV-2 mRNA vaccination booster dose.\n4. If a male subject, the subject must agree to use barrier contraception (ie, condoms) from Day 1 through 30 days following the last dose of study drug.\n\nExclusion Criteria\n\nSubjects who meet any of the following criteria will be excluded from participation in the study.\n\nLaboratory related exclusion criteria should be assessed using historical records and lab results available in the subjects' electronic medical records.\n\n1. Hypoxemia for any reason, defined as either oxygen saturation (SpO2) ≤ 93% on room air or a requirement for supplemental oxygen support.\n2. Participants with one of the following:\n\n   * Acute liver failure defined as INR ≥ 1.5 and altered mental status in a patient without cirrhosis or pre-existing liver disease.\n   * Acute kidney failure defined as an increase in serum creatinine of ≥0.3 mg\u002FdL within 48 hours or ≥50% within 7 days OR urine output of \\\u003C0.5 mL\u002Fkg\u002Fhour for \\>6 hours\n   * Heart failure with NYHA functional classification III or IV.\n3. Advanced cancer being treated with cytotoxic chemotherapy.\n4. Participants have end stage renal disease requiring hemodialysis or peritoneal dialysis, or chronic kidney disease with GFR \\\u003C 30 mL\u002Fmin\u002F1.73m2\n5. Participants with a known history of cirrhosis and Child-Pugh score B or C.\n6. Participants who are moderately or severely immunocompromised defined as:\n\n   * Are receiving active treatment for solid tumor and hematologic malignancies.\n   * Have hematologic malignancies (e.g., chronic lymphocytic lymphoma, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) and are known to have poor responses to COVID-19 vaccines, regardless of the treatment status for the hematologic malignancy.\n\n   Received a solid-organ or islet transplant and are receiving immunosuppressive therapy.\n   * Received chimeric antigen receptor T cell (CAR T-cell) therapy or a hematopoietic cell transplant (HCT) and are within 2 years of transplantation or are receiving immunosuppressive therapy.\n   * Have a moderate or severe primary immunodeficiency (e.g., severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome, common variable immunodeficiency disease).\n   * Have advanced or untreated HIV infection (defined as people with HIV and CD4 T lymphocyte cell counts \\\u003C200 cells\u002Fmm3, a history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV).\n   * Are receiving active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, or immunosuppressive or immunomodulatory biologic agents (e.g., B cell-depleting agents).\n7. Participants with uncontrolled autoimmune or rheumatologic disease.\n8. Participants have received 6 doses or more of the COVID-19 vaccine. (Removed in Amendment 3)\n9. Participants with a history of myocarditis, pericarditis, or myopericarditis.\n10. Participants with a history of anemia or bleeding disorders. For anemia, the exclusion criterion will be met if any of the following are true:\n\n    i. Active anemia, defined as Hb\\\u003C9 g\u002FdL within 30 days prior to screening,\n\n    ii. Unresolved anemia: Hb\\\u003C11 g\u002FdL (females) or \\\u003C12 g\u002FdL (males) during any window of \\>=3 months in the past year AND no evidence of measures of correction (e.g. iron supplementation, transfusion) in the same time window,\n\n    iii. High risk etiologies of anemia: myelodysplastic syndromes, aplastic anemia, hemoglobinopathies (e.g., sickle cell trait, sickle cell anemia), anemia due to malignancy, anemia due to chronic kidney disease, anemia due to untreated nutritional deficiencies, anemia due to toxic exposures (e.g., chronic lead poisoning), or any other high-risk etiology as determined by the study investigator,\n\n    iv. Anemia with intensive recent (within 6 months) interventions, including red blood cell transfusion or IV iron infusion,\n\n    v. Symptomatic anemia in the year prior to screening, including shortness of breath, exercise intolerance, type 3 myocardial infarction, if clearly attributed to the anemia.\n11. Participants who have precautions or contraindications to COVID-19 vaccine per the CDC interim clinical considerations for use of COVID-19 vaccines, including the following:\n\n    * History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine\n    * History of a diagnosed non-severe allergy to a component of the COVID-19 vaccine\n    * History of a non-severe, immediate (onset less than 4 hours) allergic reaction after administration of a previous dose of one COVID-19 vaccine type\n    * Moderate or severe acute illness, with or without fever\n    * History of multisystem inflammatory syndrome in adults\n    * History of myocarditis or pericarditis within 3 weeks after a dose of any COVID-19 vaccine\n12. History of allergy or intolerance to Ta1.\n13. SARS-CoV-2 or other infection, during screening.\n14. SARS-CoV-2 mRNA or other SARS-CoV-2 vaccination during the previous 6 months.\n15. Participants who have dermatologic conditions that could affect local solicited adverse event (AE) assessment (e.g., psoriasis patches affecting skin over the sites of injection).\n16. Any medical condition that, in the judgement of the Investigator, could interfere with treatment or compliance with the protocol.\n17. Has received an investigational drug within the previous 30 days.","65 Years","100 Years",{"count":56,"type":22},75,"INTERVENTIONAL",[59],"PHASE1","The goal of this research is to learn more about ZADAXIN® (trade name; thymalfasin generic; Ta1 for short) and determine if Ta1 has any benefit in increasing the immune response to the COVID-19 vaccine. Ta1 has been shown to stimulate the immune system to fight infections.\n\nThis research study will test the safety and possible harms of Ta1 when it is given to people at different dose levels before COVID-19 vaccination.",[27,62,63],"COVID-19 Vaccine","Immune Response to Covid 19 Vaccination","2025-07-30",{"date":66,"type":39},"2025-07-31",{"date":68,"type":39},"2024-12-02",{"date":70,"type":22},"2026-12-01",{"name":72,"class":46},"The Methodist Hospital Research Institute",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":57,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":5},"100500878","phase-4-durability-of-vaccine-responses-100500878","NCT05801978","Durability of Vaccine Responses","Systems Biological Assessment of the Durability of Vaccine Responses","Inclusion Criteria:\n\n* Able to understand and give informed consent.\n* Age 18-50 years.\n* Participants agree not to take any live vaccines 30 days before or after (14 days for inactivated) vaccination.\n* Women of child bearing potential must agree to use effective birth control for the first 3 months of the study. A negative urine pregnancy test must be documented prior to vaccination and prior to tissue sampling procedures.\n\nExclusion Criteria:\n\n* History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products.\n* History of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.\n* History of Hepatitis B or Hepatitis C infection.\n* Chronic clinically significant medical problems that could affect the immune response, require medication that would affect the immune response, or have signs or symptoms that could be confused with reactions to vaccination, including (but not limited to):\n\n  1. Insulin dependent diabetes\n  2. Severe heart disease (including arrhythmias)\n  3. Severe lung disease\n  4. Severe liver disease\n  5. Severe kidney disease\n  6. Grade 4 hypertension (\\*Grade 4 hypertension per CTCAE criteria is defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit))\n* Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of uncontrolled autoimmune disorder.\n* Pregnancy or breast feeding, or plans to become pregnant in the first 3 months of study participation.\n* Receipt of blood products or immune globulin product within the prior 3 months.\n* Active duty military.\n* History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial.\n\nAdditional Exclusion Criteria for YF-17D Arm\n\n* History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, or Japanese encephalitis vaccination or infection.\n* Previous residence in a country where there is a risk of yellow fever virus (YFV) transmission\n* History of allergy to eggs, chicken, or gelatin.\n\nAdditional Exclusion Criteria for QIV Arm\n\n* History of influenza infection within the same influenza season.","50 Years",{"count":83,"type":22},66,[85],"PHASE4","The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a \"wait and see\" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown.\n\nThis study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts.",[27],[89,90],"Durability","Immune Response","2025-06-26",{"date":93,"type":39},"2025-07-01",{"date":95,"type":39},"2023-04-11",{"date":97,"type":22},"2026-09-30",{"name":99,"class":46},"Emory University"]