[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaccine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaccine":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,67,97,125,156,192],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100397831","phase-4-clinical-trial-assessing-the-immunogenicity-of-an-anti-pneumococcal-vaccination-strategy-pcv13ppv23-versus-prevenar20-in-adult-patients-treated-for-a-lymphoma-100397831",false,"NCT04460235","Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma","Immunogénicité de la Vaccination Anti-pneumococcique (PCV13+PPV23 Versus PREVENAR20) Dans le Lymphome Chez l'Adulte","HEMATOVAC","Inclusion Criteria:\n\n* Patient ≥ 18 year-old.\n* AND medical follow-up in hematology unit\n* AND had received a first course of chemotherapy for diffuse large B cell lymphoma or for follicular lymphoma\n* Life expectancy \\> 6 months.\n* Negative pregnancy test.\n* Having signed the consent form.\n* Having an health insurance.\n\nExclusion Criteria:\n\n* Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol.\n* Uncontrolled bacterial, viral or fungal infection less than 7 days.\n* Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in childhood. The last injection must be performed at least five years ago).\n* Preexisting condition that altered the immune response: splenectomy, HIV, primary or secondary immune deficiency, nephrotic syndrome, sickle cell anemia, autoimmune disorder, solid organ transplantation, immunosuppressive drugs or biotherapy not included in the chemotherapy.\n* Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion.\n* Major blood clotting disorders preventing intramuscular injection.\n* Medical history of anaphylactic reaction to vaccination.\n* Known allergy to one of the vaccine components.\n* Involvement to another vaccine biomedical research.\n* Protected person.\n* Pregnant women or women of childbearing age without appropriate contraceptive measures.\n* Perfusion of polyvalent immunoglobulins during follow-up.\n* Participants with hypersensitivity to aluminum phosphate, phenol or CRM197 protein, protein derived from Corynebacterium diphtheria.","ALL","18 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal (PCV13) injection followed 2 months later by polysaccharide 23-valent (PPV23) vaccine injection. In 2024, Health authorities changed guidelines to recommend one injection of PREVENAR20 instead of the 2-vaccine scheme general practitioners are usually in charge of this vaccination. Conjugated pneumococcal vaccine enhances the immunogenicity of the polysaccharide vaccine. Acute leukemia and lymphoma are treated with multiple courses of chemotherapy, impairing the immune system and potentially the response to vaccination. These patients are more at risk for developing pneumococcal invasive diseases than the general population. However, efficacy of pneumococcal vaccination is poorly documented in this setting. We assume that 65% of the patients are non-responders to double compared to 45% for PCV20PREVENAR20 vaccination, according to their anti-pneumococcal immunoglobulin G (Ig) titers and the opsonophagocytic activity (OPA). To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, we will measure anti-pneumococcal serotype-specific IgG titers and OPA at different time-points after completion of the combined vaccine strategy. The primary objective is to assess the immunogenicity of pneumococcal vaccination combined strategy at 3 months after the PCV13 injection (corresponding to 1 month after the end of the combined strategy in cohort A) using Ig G titers and OPA, compared to 3 months post PREVENAR20 (cohort B). At different time points (day 0, 4 weeks post PCV13, and 4 weeks, 3-6 months and 9-12 months post PPV23 and in day 0, 4 weeks post PREVENAR20 and 3 months, 5-8 months and 11-14 months post PREVENAR20, the immunological response to vaccination will be monitored using specific-serotype IgG titers, OPA, and total anti-pneumococcal Ig. We will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.",[27,28,29],"Vaccine","Streptococcus Pneumoniae","Lymphoma, Non-Hodgkin","RECRUITING","2026-05-27",{"date":33,"type":34},"2026-05-29","ACTUAL",{"date":36,"type":34},"2021-09-07",{"date":38,"type":21},"2029-06",{"name":40,"class":41},"Poitiers University Hospital","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100603356","phase-4-induction-of-cross-protective-antibodies-for-serogroup-33-by-pneumococcal-conjugate-vaccines-100603356","NCT07135453","Induction of Cross-protective Antibodies for Serogroup 33 by Pneumococcal Conjugate Vaccines","Novel Serotype Alert: Investigate New Pneumococcal Conjugate Vaccines for Inducing Cross-protection Against Newly Discovered Serotype 33E and Putative Novel Serogroup 33 Serotypes","Group 33\u002FPCVs","Inclusion Criteria:\n\n* Healthy adult\n\nExclusion Criteria:\n\n* No prior history of pneumococcal vaccination\n* No immunosuppressing medications or chronic diseases that affect immune function",true,{"count":52,"type":21},70,[24],"The goal of this study is to learn whether different types of vaccines to prevent bacterial infections are able to effectively create antibodies that defend against certain types of bacteria.\n\nWe will give two different types of vaccine and evaluate the effectiveness of antibodies produced by each vaccine in killing bacteria.",[27,56],"Pneumococcal Disease","2026-05-04",{"date":59,"type":34},"2026-05-05",{"date":61,"type":21},"2026-05",{"date":63,"type":21},"2027-08",{"name":65,"class":41},"University of Alabama at Birmingham",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":66},"100568506","a-clinical-study-of-personalized-self-dc-vaccine-targeting-neoantigen-in-treatment-of-advanced-solid-tumor-100568506","NCT06682117","A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor","Neo-DCV-001","Inclusion Criteria:\n\n1. 18-75 years.\n2. Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).\n3. HLA typing was HLA-A0201\u002F1101\u002F2402 (containing at least one of the typing, according to the central laboratory issued).\n4. Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).\n5. Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation \u002F ALK fusion positive), esophageal squamous cell carcinoma).\n6. Voluntary to participate in clinical research ; the person or legal guardian fully understands and is informed of this study and sign the informed consent; willing to follow and be able to complete all test procedures;\n7. ECOG score 0-1.\n8. Have a venous access to meet single collection or venous blood collection;\n9. Expected survival time ≥ 6 months.\n10. Subjects were willing to study the use of reliable contraceptive methods during treatment and within 3 months after the end of treatment, and women of childbearing age.\n11. Have adequent organ functions.\n12. Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs, immune checkpoint inhibitors, other clinical trial research drugs, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments received have passed the 4-week elution period, and the toxic and side effects returned to grade 1 or lower (except for alopecia, vitiligo and other tolerable events judged by researchers) ; 2) If undergoing major surgery within 3 weeks, the adverse reactions have returned to grade 1 or lower.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Patients with a history of severe immediate allergies to the cells and any drugs used in this study.\n3. Those with a history of organ transplantation.\n4. Known central nervous system metastasis.\n5. Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.\n6. Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.\n7. Suffering from severe liver and kidney function damage (liver, kidney treatment but still not controllable, biochemical indicators can not meet the inclusion criteria of NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poor drug control of hypertension ( systolic blood pressure more than 160mmHg and\u002For diastolic blood pressure more than 90mmHg), or with clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (6 months before signing informed consent) unstable angina, myocardial infarction (within 6 months before signing informed consent), unstable angina, New York Heart Association, or any circumstances which, in the opinion of the researcher, may increase the risk of the subject or interfere with the results of the test.\n8. Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.\n\n   Corticosteroids (prednisone or the same drug dose less than 10mg\u002Fday ) or other immunosuppressive agents were excluded.\n9. Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.\n10. The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.\n11. The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.\n12. There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.\n13. Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.","75 Years",{"count":76,"type":21},9,[78],"NA","This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.",[81,82,27,83],"Treatment","Neoantigen","Solid Tumor Cancer",[85,86,87],"advanced solid tumors","DC vaccine","neoantigen","2026-03-28",{"date":90,"type":34},"2026-04-02",{"date":92,"type":34},"2024-11-15",{"date":94,"type":21},"2026-12-30",{"name":96,"class":41},"Fudan University",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":66},"100525991","connecting-friends-and-health-workers-to-boost-covid-19-vaccination-in-latino-communities-100525991","NCT06128928","Connecting Friends and Health Workers to Boost COVID-19 Vaccination in Latino Communities","REDES: a Peer Network and mHealth Community Health Worker (CHW) Model to Improve COVID-19 Vaccination Among Latinos","REDES","Inclusion Criteria:\n\nEligibility criteria for index participants (eligibility for index participants is intended to select participants who are less vaccine hesitant):\n\n* Age 18 years or older, and\n* Self-identifies as Hispanic\u002FLatino, and\n* Living in Maryland, and\n* Has received at least one COVID-19 vaccine\u002Fbooster in the last 12 months.\n\nEligibility criteria for primary and secondary network members (peers):\n\nEligibility for peers is intended to select for participants who are more vaccine hesitant (e.g. unvaccinated, or have not received at least one COVID-19 vaccine\u002Fbooster in the last 12 months)\n\n* 18 years old or older, and\n* Self-identifies as Hispanic\u002FLatino, and\n* Living in Maryland, and\n* Provide a study coupon to verify that they were referred by an index or a primary network member, and\n* Has not received at least one COVID-19 vaccine\u002Fbooster in the last 12 months.\n\nExclusion Criteria:\n\n* Previously participated in the study\n* Lacks capacity to consent",{"count":106,"type":21},900,[78],"The goal of this clinical trial is to find out which approach works better in getting more of the friends and connections of Latino adults get vaccinated against COVID-19.\n\nThe main questions this study aims to answer are:\n\n1. Can teaching people to use motivational interviewing help more friends and connections of Latino adults get the COVID-19 vaccine compared to just giving information about the vaccine?\n2. What are the things that make it easier or harder for Latinos and networks to get the COVID-19 vaccine?\n3. How does this intervention work in practice so that it can be made available to more people in the future\n\nThe researchers will compare the vaccine rates of the friends and connections of Latinos who have been trained in motivational interviewing with those who have only been given information about the COVID-19 vaccine. This will help figure out which method works best to encourage more people to get vaccinated.",[110,27],"COVID-19",[112,113,114,115],"COVID-19 vaccine uptake","Latino","vaccine hesitancy","Network referrals","2025-11-07",{"date":118,"type":34},"2025-11-12",{"date":120,"type":34},"2023-07-08",{"date":122,"type":21},"2026-12-31",{"name":124,"class":41},"Johns Hopkins University",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":66},"100577493","phase-1-safety-and-immunogenicity-of-a-self-amplifying-rna-vaccine-against-crimean-congo-hemorrhagic-fever-100577493","NCT06799013","Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever","A Phase 1, Open Label, Dose-Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of a Nanoparticle Carrier-Formulated Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever (HDT-321) in Healthy Adults","Inclusion Criteria:\n\n1. Males and non-pregnant females 18 to 64 years of age at the time of signing the ICF.\n2. Body mass index (BMI) 17 to 35 inclusive at screening.\n3. Considered by the PI or designee to be in good general health as determined by medical history, physical examination, vital sign measurements\\*, and clinical laboratory assessments conducted no more than 30 days prior to the first study injection administration.\n4. Screening laboratory values within the laboratory reference ranges or considered non-clinically significant (NCS) if within Grade 1 severity on the toxicity grading scale.\n5. Negative human immunodeficiency virus (HIV) 1\u002F2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.\n6. Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception3 for at least 30 days prior to the first injection and for 60 days after the last injection. Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of and prior to each study injection.\n7. Able to understand and comply with planned study procedures and willing to be available for all study required procedures, visits, and telephone calls for the duration of the study.\n8. Provide written informed consent before initiation of any study procedures.\n9. Willing to abstain from donating whole blood or blood derivatives 30 days prior to screening and for the duration of the study.\n10. Willing to refrain from receiving any licensed vaccine within 28 days prior to and after scheduled study injections.\n\nExclusion Criteria:\n\n1. Any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. Including Acute, subacute, intermittent, or chronic medical diseases or conditions that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of the trial. Significant respiratory disease (COPD) requiring daily medications, asthma that is not well controlled, significant cardiovascular disease, history of myocarditis or pericarditis, myocardial infarction, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia, Neurological or neurodevelopmental conditions, ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, blood dyscrasias or significant disorder of coagulation, chronic liver disease, including fatty liver, autoimmune disease, including localized or history of psoriasis or hypothyroidism without a defined non-autoimmune cause and Immunodeficiency of any cause.\n2. Abnormal screening electrocardiogram (ECG)\n3. History of hypersensitivity or severe reactions to previous vaccinations\n4. History of hypersensitivity or severe reactions to products known to contain polyethylene glycol (PEG).\n5. Allergy to antibiotics structurally similar to kanamycin (including but not limited to neomycin, streptomycin, tobramycin, and gentamycin).\n6. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunemodifying drugs within 6 months prior to the first study injection (for corticosteroids: prednisone ≥20 mg\u002Fday or equivalent). Intra-articular, inhaled, nasal, and topical steroids are allowed.\n7. Received immunoglobulins or any blood products within 60 days prior to enrollment\u002FDay 1.\n8. Donated blood products within 30 days prior to enrollment\u002FDay 1.\n9. Received an investigational or non-registered medicinal product within 30 days prior to screening.\n10. Currently enrolled, or plan to participate, in another clinical trial with an investigational agent to be received during the study period.\n11. Received or plans to receive any non-study vaccine within 28 days before and after each study injection.\n12. Febrile illness\\*, as determined by the participating site PI or appropriate sub-investigator, with or without fever (oral temperature ≥38.0°C\u002F100.4°F), within 24 hours prior to each study injection.\n13. Current heavy smoking\u002Fvaping (defined as 1 pack or more of cigarettes a day or vaping equivalent\\*). \\*1-2 mL of 20 mg\u002FmL of nicotine salt\n14. Known or suspected alcohol or illicit drug abuse within the past 12 months prior to Study Day 1.\n15. Breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last study injection.\n16. Participants unlikely to cooperate with the requirements of the study protocol.","64 Years",{"count":134,"type":21},48,[136],"PHASE1","The goal of this clinical trial is to assess the safety, tolerability and immunogenicity of three dosage levels, and a single or two-dose administration regimen, of the investigational HDT-321 product administered intra-muscularly. The main questions it aims to answer are:\n\n* Is HDT-321 safe to use\n* Does HDT-321 provide protection against Crimean-Congo hemorrhagic fever virus (CCHFV)\n\nResearchers will record any adverse events and test blood samples to see if HDT-321 is safe and works to protect participants against Crimean-Congo hemorrhagic fever virus (CCHFV)\n\nParticipants will:\n\n* Receive 1 or 2 doses of HDT-321\n* Complete a memory aid and measurements for 7 days after receiving each dose of HDT-321\n* Be followed throughout the study using phone calls and clinic visits to check for and record adverse events\n* Provide blood samples at specific study visits",[27,139],"Crimean-Congo Hemorrhagic Fever",[27,141,142,143,144,145],"Healthy","18-64","Male","Female","Preventative","2025-07-23",{"date":148,"type":34},"2025-07-28",{"date":150,"type":34},"2025-07-10",{"date":152,"type":21},"2027-07",{"name":154,"class":155},"HDT Bio","INDUSTRY",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":169,"conditions":170,"keywords":176,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":66},"100598966","phase-1-clinical-trial-phase-iiia-to-evaluate-the-safety-and-immunogenicity-of-streptincor-100598966","NCT07078357","Clinical Trial Phase I\u002FIIa to Evaluate the Safety and Immunogenicity of StreptInCor","Phase I\u002FIIa Clinical Trial to Evaluate the Safety and Immunogenicity of StreptInCor, a Synthetic Vaccine Against Streptococcus Pyogenes, in Healthy Adult Volunteers.","StreptInCorVac","Inclusion Criteria:\n\n* • Healthy male or female volunteers, aged between 18 and 45 years;\n\n  * Availability to undergo all procedures throughout the study period;\n  * Provide free and informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Participation in clinical trials within the last year\n* Participation in cohort studies\n* Diagnosis of concomitant infections or diseases that may affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasms, and autoimmune diseases;\n* Current or previous diagnosis or family history of ARF, chorea, obsessive-compulsive disorder, or glomerulonephritis;\n* Current or previous diagnosis of heart diseases;\n* Severe asthma or chronic obstructive pulmonary disease (COPD);\n* Abnormal neurological clinical assessment, especially chorea;\n* Use of treatments that may affect immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplastic agents;\n* Use of treatments that may affect heart valves in the last four weeks or planned during the study period, including fenfluramine and dexfenfluramine;\n* Renal insufficiency determined by estimated creatinine clearance below 45 ml\u002Fmin\u002F1.73m²;\n* History of intolerance or allergy to any component of the study product, including antigen or adjuvant;\n* Presence of valve abnormalities or alterations in cardiac anatomy as defined by echocardiogram;\n* Altered electrocardiogram;\n* Evidence or suspicion of recent S. pyogenes infection based on clinical symptoms in the last four weeks;\n* Pregnancy, breastfeeding mother, or intention to become pregnant during the study period (only female participants);\n* Any other condition that may interfere with the study process as assessed by the researchers, including sample size and statistical power.","45 Years",{"count":166,"type":21},60,[136,168],"PHASE2","This is a Phase I\u002FIIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor. The study will include four different doses (25 µg, 50 µg, 100 µg, and 200 µg) of StreptInCor produced under Good Manufacturing Practices (GMP) and formulated with aluminum hydroxide as the vaccine adjuvant. The adjuvant alone will be used as a placebo in this trial. Five groups, each consisting of twelve healthy adult volunteers, will randomly receive two doses of the vaccine or placebo with a 28-day interval, along with a booster dose six months after the initial vaccination",[171,172,173,174,175,27],"Rheumatic Heart Disease","Rheumatic Heart Disease in Children","Vaccine Adverse Reaction","Rheumatic Diseases","Vaccine Acceptance",[177,178,179,180,181],"Acute rheumatic fever","Rheumatic heart disease","Vaccine development program","Group A streptococcus (GAS)","Streptococcus pyogenes","NOT_YET_RECRUITING","2025-07-17",{"date":185,"type":34},"2025-07-22",{"date":187,"type":21},"2025-10-01",{"date":189,"type":21},"2028-12-01",{"name":191,"class":41},"University of Sao Paulo General Hospital",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":212,"locationsCount":66},"100594185","phase-1-an-open-label-dose-finding-phase-i-study-to-evaluate-the-safety-and-immunogenicity-of-a-bivalent-klebsiella-pneumoniae-vaccine-cho-v08-in-healthy-adults-100594185","NCT07016152","An Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of a Bivalent Klebsiella Pneumoniae Vaccine (CHO-V08) in Healthy Adults","Inclusion Criteria:\n\n* Male or non-pregnant female, aged 18 to 50 years old (inclusive) for Cohorts 1 and 2 at the Screening visit.\n* Body mass index (BMI) of 18.0 to 30.0 kg\u002Fm2 (inclusive) at the Screening visit.\n* Physically and mentally capable of participating in the study and willing to adhere to study procedures.\n* Able to provide signed informed consent.\n* In generally good health by medical history, physical examination, vital signs, and clinical laboratory findings at the Screening visit based on the investigator's judgment.\n* Negative serology test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.\n* Female subject with childbearing potential must have a negative result of pregnancy test at the Screening visit.\n* Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period.\n* Male subject who agrees to use an adequate method of contraception during the study period.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of AEs.\n* Suspected or known hypersensitivity (including allergy) to any of the vaccine components.\n* History of hypersensitivity or allergy to any vaccine, especially pneumococcal vaccine.\n* Current or previous, confirmed, or suspected disease caused by Klebsiella pneumoniae.\n* Medical conditions as a contraindication to the intramuscular vaccination and blood draws, e.g., coagulation disorder.\n* Any abnormality or permanent body art (e.g., tattoo) that would interfere with the observation of local reactions at the injection site (deltoid region).\n* Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal diseases and\u002For insufficiency as determined by physical examination or laboratory tests.\n* Known or suspected impairment of immunological function, e.g., asplenia\u002Fsplenectomy or history of autoimmune\u002Fimmune-mediated diseases or lymphoproliferative disorders.\n* Any screening laboratory abnormalities that are Grade 2 or above or deemed clinically significant in the opinion of the investigator.\n* Subjects with an electrocardiogram (ECG) at the Screening visit that demonstrates clinically relevant abnormalities which may affect subject safety or study results in the opinion of the investigator.\n* Positive test for SARS-CoV-2 virus at the Screening visit.\n* Use of any antibiotic therapy within 1 week prior to the first study vaccination.\n* History of any chronic or progressive disease that, according to judgment of the investigator, could interfere with the study outcomes or pose a threat to the subject's health.\n* History of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.\n* History or presence of heavy smoking (defined as \\> 10 cigarettes per day; approximately half pack per day) as documented in medical chart or by verbal confirmation at the Screening visit.\n* Documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months prior to the Screening visit.\n* Received any vaccination (live, inactivated, or bacterial) within 1 month prior to the Screening visit and plans to receive vaccination within 4 weeks after the last study vaccination during the study period. Exception can be made with marketed vaccines against seasonal influenza or COVID-19 outside the 28-day window of the study vaccination.\n* Received major surgery or radiation therapy within 3 months prior to the Screening visit.\n* Onset of influenza-like illness as defined by: fever (temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production, dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat within 1 week prior to the Screening visit.\n* Female subject who is pregnant or lactating at the Screening visit or plans to be pregnant during the study period or lactate from the time of the first vaccination through 60 days after the last vaccination.\n* Received any investigational drug or device or have participated in a clinical study within 3 months prior to the Screening visit.\n* Any confirmed or suspected abnormal immune function, immunosuppression, or immunodeficiency or received any immunosuppressants (including systemic corticosteroids) or immunomodulators within 3 months prior to the Screening visit.\n* Had blood donation within 2 weeks prior to the Screening visit.\n* Received any blood products or immunoglobulin within 3 months prior to the Screening visit.","50 Years",{"count":200,"type":21},40,[136],"CHO-V08 is currently being developed as a prevention vaccine against nosocomial and community-acquired infection caused by hypervirulent Klebsiella pneumoniae K1 and K2 serotypes. The goal of study (KLEBBI-001) is to evaluate the safety, reactogenicity, and immunogenicity of the preventive vaccine of CHO-V08 in healthy volunteers aged from 18 to 50 years old.",[204,27],"Klebsiella Pneumoniae Infection",[204,27],"2025-06-26",{"date":208,"type":34},"2025-06-27",{"date":206,"type":34},{"date":211,"type":21},"2027-04-10",{"name":213,"class":155},"Cho Pharma Inc."]