[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaccine-reaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaccine-reaction":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,73,97,123,149,173,196],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643497","reduced-vaccine-response-to-hzsu-in-sle-100643497",false,"NCT07636044","Reduced Vaccine Response to HZ\u002Fsu in SLE","Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Males or females ≥ 50 years of age at time of consent\n* ≥ 4 of the 1997 ACR13 or the 2012 SLICC\u002FACR criteria for SLE (14, 15)\n* Clinically stable SLE\n* Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks\n* Corticosteroid use: ≥ 5mg\u002Fday of prednisolone equivalent\n* Antimalarials (≤ 400 mg\u002Fday)\n* Azathioprine (≤ 3 mg\u002Fkg\u002Fday)\n* Mycophenolate mofetil (≤ 3 mg\u002Fday)\n* Tacrolimus (≤ 5mg\u002Fday)\n* Methotrexate (≤ 20mg\u002Fweek)\n* Cyclosphosphamide (≤ 1mg\u002FBSA\u002Fmonth)\n* Must be eligible for the indication of adjuvanted herpes zoster subunit vaccine\n* Must understand and voluntarily sign an informed consent form including writing consent for data protection\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Acute infection with temperature \\>38C at the time of vaccination\n* Previous anaphylactic response to vaccine components or to egg\n* History of Guillain-Barre syndrome or demyelinating syndromes\n* Any condition including laboratory abnormality which places the subject at unacceptable risk\n* Subjects who decline to participate",true,"ALL","50 Years",{"count":20,"type":21},80,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to compare the vaccine response to the 2 doses of the adjuvanted herpes zoster subunit vaccine(HZ\u002Fsu, \"Shingrix\") in patients with SLE and the age-, sex-, ethnicity-matched controls without autoimmune disease.",[25,26,27],"Vaccine Reaction","Zoster","Systemic Lupus Erythematosus","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-09","ACTUAL",{"date":34,"type":32},"2024-10-01",{"date":36,"type":21},"2030-10-01",{"name":38,"class":39},"Seoul National University Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100607908","phase-4-r21mm-dosing-presentations-and-preservatives-100607908","NCT07194668","R21\u002FMM Dosing, Presentations, and Preservatives","Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21\u002FMatrix-M - A Noninferiority Trial","VAC100","Inclusion Criteria:\n\n* Residence in a study village for the study period, i.e. 12 months.\n* Age 14 years to 60 years.\n* Written informed consent\u002Fassent provided by participants (or a parent\u002Fguardian in case the participant is under 18 years old).\n\nExclusion Criteria:\n\n* Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.\n* Acute illness requiring intervention.\n* A history of an adverse reaction to study vaccine.\n* Prior receipt of any other malaria vaccine.\n* Enrolment in another intervention trial in the last month.\n* Planned enrolment in another intervention trial in the coming 12 months.\n* Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and\u002For planned for the coming 12 months.","14 Years","60 Years",{"count":52,"type":21},375,"INTERVENTIONAL",[55],"PHASE4","This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21\u002FMatrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.\n\nAll participants will receive the same number of injections and will be randomly assigned to receive one of the followings:\n\n* Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21\u002F50μg Matrix-M (n=125).\n* Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21\u002F50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125)\n* Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21\u002F50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125)\n\nClinical procedure for participants:\n\n* Standardized symptom questionnaire\n* Physical examination:\n\nWeight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential)\n\n* Venous blood collection (Pre-vaccination) 3mL\n* Vaccination",[58,59,25],"Plasmodium Falciparum Malaria","Malaria",[58,61],"Malaria Vaccine","NOT_YET_RECRUITING","2026-03-12",{"date":65,"type":32},"2026-03-16",{"date":67,"type":21},"2026-04-01",{"date":69,"type":21},"2026-12-31",{"name":71,"class":39},"University of Oxford",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":16,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":53,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":40},"100521281","early-phase-1-intradermal-influenza-vaccination-100521281","NCT06067555","Intradermal Influenza Vaccination","Characterization of Immune Response to Intradermal Influenza Vaccination","In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study, as well as have deidentified samples and data stored for future research.\n3. Able to proficiently speak, read, and write English.\n4. Male or female, aged 18-40 years old at time of initial enrollment\n\n   a. Participant is allowed to participate in subsequent influenza seasons even if they will be \\>40 years old.\n5. In good general health as evidenced by medical history\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. CBC with differential, lymphocyte phenotyping with T, B, and natural killer cells (TBNK), complete metabolic panel, anti-CMV immunoglobulin (Ig) G and IgM, and\u002For anti-Epstein-Barr virus (EBV) antibody panel values outside of the Yale Department of Laboratory Medicine normal reference ranges and deemed clinically significant by the PI at the time of screening.\n2. Positive result for anti-HIV 1\u002F2 antibody screening at the time of screening.\n3. Prior receipt of a current seasonal influenza vaccine (for the season of participation).\n4. History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein).\n5. History of severe reactions to vaccines.\n6. Use of an oral glucocorticoid within the past 30 days.\n7. Receipt of a live-attenuated vaccine within the past 3 months.\n8. Receipt of any experimental vaccine.\n9. Receipt of any other type of vaccine (non-live and non-experimental, e.g., tetanus, diphtheria, and pertussis \\[TDaP\\]) within the past 3 months.\n10. Planned vaccination before day 100 after study vaccination.\n11. Current or recent use (within the past 90 days) of immunoglobulin therapy.\n12. Surgery within the past 8 weeks, or planned surgery before day 28.\n13. Current (within the past 30 days) treatment for active malignancy.\n14. Cancer chemotherapy in the past 2 years.\n15. Administration of any blood products within 90 days of the screening, or planned administration before day 100.\n16. History of parasitic, amebic, fungal, or mycobacterial infections within the past 1 year, with the exception of tinea pedis and onychomycosis.\n17. History of autoimmune or autoinflammatory disease.\n\n    a. In particular skin-related (i.e. psoriasis, lichen planus, lupus, neutrophilic dermatoses, atopic dermatitis)\n18. History of keloids\n19. History of a bleeding disorder.\n20. Current use (within the past 30 days) of illicit drugs (per subject report), with the exception of marijuana.\n21. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition), within the past 30 days.\n22. Serious, ongoing, uncontrolled infection within the past 30 days as per the judgement of the PI.\n23. History of Guillain-Barre syndrome (GBS).\n24. BMI ≥ 30.\n25. Known or suspected immunodeficiency within 1 year, including documented HIV infection.\n26. Pregnancy or planning to become pregnant during the study period. (Women of childbearing potential must have a negative urine or serum pregnancy test at screening.)\n27. Presence of conditions that, in the judgment of the PI, may put the individual at undue risk or compromise the scientific objectives of the study.\n\nCo-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the PI. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the PI.","18 Years","40 Years",{"count":83,"type":21},249,[85],"EARLY_PHASE1","The goal of this study is to characterize the immune response, both innate and adaptive, as well as locally and systemic, to intradermal (ID) vaccination in healthy individuals. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an FDA-approved device MicronJet. Investigators will measure antibody titers, cell subtypes, and multi-omic profiles, by collecting skin and peripheral blood at baseline and at several time points after vaccination. The primary objective is to identify baseline correlates of immune response in the skin and peripheral blood to the seasonal influenza vaccine. The investigators secondary goals are to describe the inflammatory response in the skin over time.",[25],"2025-06-16",{"date":90,"type":32},"2025-06-19",{"date":92,"type":32},"2024-01-24",{"date":94,"type":21},"2026-05",{"name":96,"class":39},"Yale University",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":16,"sex":17,"minAge":104,"maxAge":18,"enrollmentInfo":105,"targetDuration":4,"studyType":53,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":120,"locationsCount":4},"100476312","phase-3-immunogenicity-and-safety-following-in-house-recombinant-hepatitis-b-vaccine-in-indonesian-population-phase-iii-100476312","NCT05482295","Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)","Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)","Inclusion Criteria:\n\n1. Healthy individual aged 10 - 50 years old, as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.\n2. Subjects\u002Fparents\u002Fguardian(s) have been informed properly regarding the study and signed the informed consent form\u002F informed assent form.\n3. Subject\u002Fparents\u002Fguardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria:\n\n1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.\n2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years.\n3. Evolving severe illness and\u002For chronic disease and fever (axillary temperature \\>= 37.5 C) within the 48 hours preceding enrollment.\n4. Known history of allergy to any component of the vaccines (based on anamnesis).\n5. HBsAg positive.\n6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).\n7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n8. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppressant.\n9. Pregnancy \\& Lactation (Adult).\n10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.","10 Years",{"count":106,"type":21},540,[108],"PHASE3","This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.",[25,111],"Vaccine Adverse Reaction",[113],"Hepatitis B vaccine, Vaccine","2025-06-03",{"date":116,"type":32},"2025-06-06",{"date":118,"type":21},"2025-09",{"date":94,"type":21},{"name":121,"class":122},"PT Bio Farma","INDUSTRY",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":16,"sex":17,"minAge":80,"maxAge":18,"enrollmentInfo":131,"targetDuration":4,"studyType":53,"phases":132,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100591885","phase-1-safety-and-immunogenicity-of-pcv-lite-a-low-dose-of-pneumococcal-conjugate-vaccine-with-litevax-adjuvant-100591885","NCT06986239","Safety and Immunogenicity of PCV-LITE, a Low-dose of Pneumococcal Conjugate Vaccine With LiteVax Adjuvant","Safety, Tolerability and Immunogenicity of One Single Administration of PCV-LITE, a Novel Adjuvanted Pneumococcal Conjugate Vaccine Supplemented With LiteVax Adjuvant, in Young Healthy Participants","PCV-LITE","Inclusion Criteria:\n\n* Written signed informed consent obtained before any study-related activities.\n* Aged 18 to 50 years inclusive, at the time of signing the ICF.\n* Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination (PE) and laboratory tests within 21 days prior to enrolment.\n* Participants with a BMI within the range 18.5 to 35 kg\u002Fm2 inclusive at screening.\n* Women who are not pregnant or breastfeeding, and one of the following conditions applies:\n\n  * Women of non-childbearing potential (WONCBP) OR\n  * WOCBP and using a highly effective contraceptive method (with a failure rate of less than 1 % per year). Appendices from at least 1 month prior to study vaccination and for 3 months post-vaccination. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to study vaccination. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. The participant should commit to abstinence for at least 1 month prior to study vaccination and for 3 months post-vaccination. If the participant will not maintain abstinence and changes her status, the participant must first commit to another highly effective method of contraception, which should be discussed with the investigator prior to terminating sexual abstinence as contraceptive method.\n* WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination at Day 1. The investigator is responsible for review of medical history and menstrual history to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Participants who are willing and able to comply with the study procedures and are in the view of the investigator capable of completing the study.\n\nExclusion Criteria: Medical Conditions\n\n* History of laboratory confirmed pneumococcal infection in the past 36 months prior to the day of study vaccination.\n* Positive (in the past, suspected or ongoing) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.\n* Past or current history of immune-mediated and\u002For autoimmune diseases as indicated by the investigator, e.g. diabetes mellitus type I and thyroid disease.\n* Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator.\n* Clinical conditions representing a contraindication for IM administration, as judged by the investigator, e.g. history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM administration or blood draws.\n* History of confirmed hypersensitivity, allergy and\u002For anaphylaxis to diphtheria toxoid or to squalene-based adjuvants, or other components of the study vaccine (aluminum phosphate, succinic acid, Polysorbate 80).\n* Current history of uncontrolled medical illness (unstable for the past 3 months) as judged by investigator, e.g. hypertension, diabetes mellitus type 2.\n* Past or current history of any neurological disorder, e.g. Guillain-Barré syndrome and seizure disorder other than: 1) childhood febrile seizures, or 2) seizures that have not required treatment within the last 3 years.\n* History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.\n* Active malignancy or malignancy within the past 5 years, except basocellular carcinoma (single lesion) that has been fully removed.\n* Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years or that is expected to require the use of oral or intravenous corticosteroids.\n* History of hereditary angioedema, acquired angioedema or idiopathic forms of angioedema.\n* History of idiopathic urticaria within the past year.\n* Current or recent (\\\u003C 2 years ago) heavy smoking (\\> 20 cigarettes per day) or heavy vaping (\\> 2 mL e-liquid daily, which correspond with 20 cigarettes; reference ). If candidate stopped smoking or vaping \\> 2 years ago, the investigator would make an individual judgement based on the total packs or use per year and the candidate's overall health status. Drug - or alcohol abuse\u002Faddiction (including alcohol dependence), or psychiatric condition (e.g., past or present psychoses; disorder requiring lithium; or within 5 years prior to administration of study vaccine, a history of suicide plan or attempt), which in the investigator's opinion could compromise the participant's safety and\u002For compliance with the protocol.\n* A rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection local reaction rating.\n\nExclusion Criteria: Prior\u002FConcomitant Therapy\n\n* Prior receipt of an investigational or licensed pneumococcal vaccine in the 36 months before administration of study vaccine or planning to receive a pneumococcal vaccination during the study period.\n* Prior receipt of a live attenuated vaccine in the 28 days prior to administration of study vaccine or within 14 days for subunit or inactivated vaccines other than pneumococcal vaccination.\n* Planning to receive a vaccine during the first 28 days following the administration of study vaccine.\n* Currently participating in another clinical study or planning to participate in another study during the study period, or administration of any investigational drug, vaccine or medical device in the 4 weeks prior to study vaccination.\n* Prior receipt of blood, blood-derived products or immunoglobulins in the 6 months prior to administration of study vaccine or planning to receipt such product during the study period.\n* Chronic administration (defined as 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to vaccination or planned administration during the study (excluding topical, inhaled and intranasal preparations and intra-articular injections). For corticosteroids, this is prednisone \\>= 20 mg\u002Fday, or equivalent.\n* Current intake of more than 1 anticoagulant medication (coumarin derivatives, low molecular weight heparin, DOAC) or 1 anticoagulant medication in combination with anti-aggregation medication.\n* Current anti-tuberculosis prophylaxis or therapy.\n* Elective surgery planned in the first 14 days following study vaccination.\n\nExclusion Criteria:Others\n\n* WOCBP who are pregnant, breast-feeding or planning to become pregnant during the study.\n* Participants with history of any medical conditions that, in opinion of the investigator, might interfere with the results of the study or pose additional risk to the participants due to participation in the study.",{"count":20,"type":21},[133],"PHASE1","Streptococcus pneumoniae is a common bacteria and major cause of serious infections like bloodstream infections, pneumonia, and meningitis. These infections are most common in children under 2 years old and adults over 65 years of age and dangerous for all age groups. Current vaccines, which contain parts of the bacteria, have significantly reduced the incidence of invasive pneumococcal disease (IPD). To broaden protection more serotypes are added to the vaccines over the years, which results in lower immune responses to the serotype-specific polysaccharides while a stronger vaccine is desired for older people and people with a weakened immune system. In addition, these complex vaccines are hardly affordable for the growing group of older adults in low- and middle-income countries (LMICs). To address these challenges, a new potent adjuvant called 'LiteVax Adjuvant' was developed. It has been shown to improve the efficacy of vaccines, even at low doses of antigen. A lower antigen dose reduces the costs of vaccines and promotes accessibility in LMICs. By testing a standard and a low dose of a commercial pneumococcal conjugate vaccine combined with LiteVax Adjuvant in healthy volunteers, we aim to determine whether the adjuvant enhances the immune response and if a lower vaccine dose is effective. At the same time, the safety of the vaccines is being investigated.",[25],[137,138,139],"Vaccine adjuvant","LiteVax Adjuvant","Pneumococcal polysaccharide conjugate vaccine","2025-05-20",{"date":142,"type":32},"2025-05-22",{"date":144,"type":21},"2025-07-01",{"date":146,"type":21},"2026-07-01",{"name":148,"class":122},"LiteVax BV",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":53,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":40},"100584372","phase-3-optimal-timing-of-hepatitis-b-vaccination-after-transplants-100584372","NCT06888479","Optimal Timing of Hepatitis B Vaccination After Transplants","Optimal Timing of Hepatitis B Vaccination After Transplants: a Randomized Clinical Study","Inclusion Criteria:\n\n1. Patients must be ≥ 16 years old;\n2. Patients receiving hematopoietic cell transplantation;\n3. Patients achieving complete molecular remission;\n4. Patients or their guardians have to sign an informed consent form before the start of the research procedure.\n\nExclusion Criteria:\n\n1. Multiple transplantations;\n2. Donors' HBV-DNA or HBsAg are positive;\n3. Patients' HBV-DNA or HBsAg are positive before transplantation or \\\u003C 3 months after transplantation;\n4. Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;\n5. Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.","16 Years",{"count":158,"type":21},1500,[108],"The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.",[162,163,25],"Transplant-Related Disorder","Hepatitis B Virus Infection","2025-03-20",{"date":166,"type":32},"2025-03-21",{"date":168,"type":21},"2025-06-01",{"date":170,"type":21},"2029-03-01",{"name":172,"class":39},"Institute of Hematology & Blood Diseases Hospital, China",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":16,"sex":17,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":53,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100569151","phase-1-phase-iii-open-label-randomized-safety-and-immunogenicity-following-dtwp-hepatitis-b-hib-ipv-vaccine-bio-farma-in-indonesian-infants-100569151","NCT06690515","Phase I\u002FII, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants","Inclusion Criteria:\n\n1. Infant 6-11 weeks of age.\n2. Infant born after 37-42 weeks of pregnancy.\n3. Infant weighing more than 2.5 kg at birth.\n4. Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.\n5. Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.\n\nExclusion Criteria:\n\n1. Child concomitantly enrolled or scheduled to be enrolled in another trial.\n2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).\n3. Known history of allergy to any component of the vaccines.\n4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n5. Known history of congenital or acquired immunodeficiency (including HIV infection).\n6. Child who has received in the previous 4 weeks of a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\\> 2 weeks).\n7. Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.\n8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.\n9. Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.","6 Weeks","11 Weeks",{"count":182,"type":21},465,[133,184],"PHASE2","This trial is open label, comparative, randomized, phase I\u002FII study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.",[111,25],"2024-11-13",{"date":189,"type":32},"2024-11-15",{"date":191,"type":21},"2025-03-01",{"date":193,"type":21},"2026-09-30",{"name":121,"class":122},3,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":16,"sex":17,"minAge":204,"maxAge":18,"enrollmentInfo":205,"targetDuration":4,"studyType":53,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":40},"100510199","b-infantis-supplementation-to-improve-immunity-in-infants-exposed-to-hiv-100510199","NCT05923333","B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV","Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial","BifIID","Inclusion Criteria Mother:\n\n* Willing and able to provide signed and dated informed consent form\n* 18 years of age or older\n* Documented HIV seropositive\n* Antiretroviral therapy initiated before the third trimester of pregnancy\n* Planning on exclusively breastfeeding the infant for the first 6 months of life\n\nInclusion Criteria Infant:\n\n* Documented HIV seronegative at birth\n* Born at term (completed at least 37 weeks of gestation)\n* Birth weight \\>2.4kgs\n\nExclusion Criteria:\n\n* Severe illnesses, e.g. Sepsis\n* current TB or known household TB contact\n* Chronic disorder or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that in the opinion of the investigator would alter immunity\n* Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections\n* Known contraindications to components of the interventional products\n* Taking additional probiotics or prebiotics\n* Any condition that in the opinion of the investigator would make participation in the trial unsafe","0 Days",{"count":206,"type":21},200,[208],"NA","The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on:\n\n* gut microbiome composition and diversity at 4 weeks of life\n* markers of intestinal inflammation and microbial translocation at 4 weeks of life\n* Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life\n\nThe secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on:\n\n* longitudinal succession of the gut microbiota composition, diversity and function\n* relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life\n* stool metabolome\n* T cell subset ontogeny during the first 9 months of life.\n\nExploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves:\n\n* infant growth\n* all-cause morbidity\n* neurodevelopment during the first 9 months of life\n* antibody responses to early childhood vaccines",[211,25,212,213],"Hiv","Microbial Colonization","Infant Development","2024-08-20",{"date":216,"type":32},"2024-08-22",{"date":218,"type":32},"2023-08-11",{"date":220,"type":21},"2027-06",{"name":222,"class":39},"University of Cape Town"]