[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Immunobiological Technology Institute (Bio-Manguinhos) \u002F Oswaldo Cruz Foundation (Fiocruz)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100643261","phase-1-bio-manguinhosfiocruz-covid-19-mrna-vaccine-booster-100643261",false,"NCT07640308","Bio-Manguinhos\u002FFiocruz COVID-19 (mRNA) Vaccine Booster","Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Bio-Manguinhos\u002FFiocruz COVID-19 (mRNA) Vaccine Booster in Healthy Adults","Inclusion Criteria:\n\n1. Men and women aged between 18 and 59 years.\n2. Negative result for SARS-CoV-2 in a rapid antigen test at screening (Visit 1) and at the inclusion visit (Visit 0).\n3. Body Mass Index \\>18.9 and \\\u003C35.0 kg\u002Fm².\n4. Body weight ≥50.0 kg for men and ≥45.0 kg for women.\n5. Complete primary vaccination for COVID-19, and at least one more booster dose, with the last booster being an mRNA vaccine approved by Anvisa.\n6. At least one booster dose with an mRNA-based vaccine, with the last booster given at least 6 months prior to the enrollment date (proven by a vaccination certificate or registration in the SI-PNI system).\n7. Participants with the potential to become pregnant (PPE), as well as men with PPE partners, must agree to use effective contraceptive methods throughout the study participation period.\n8. Ability to understand the study, its objectives, risks, and procedures, and to provide free and informed consent.\n\nExclusion Criteria:\n\n1. Presence of any active infection at the time of vaccination or fever up to 7 days before the V0 visit. Participants in this condition may be rescheduled.\n2. Administration of another vaccine up to 28 days before or planning to receive another vaccine within 29 days following the V0 visit.\n3. Absolute or relative contraindications to the mRNA-based COVID-19 vaccine:\n\n   * Confirmed prior anaphylaxis to mRNA vaccines or any of their components, especially polyethylene glycol (PEG).\n   * History of anaphylaxis to other vaccines or injectable medications.\n   * History of myocarditis or pericarditis prior to vaccination.\n   * History of multisystem inflammatory syndrome (MIS-C or MIS-A).\n4. Previous diagnosis of immunodeficiency, autoimmune diseases, or cardiomyopathies.\n5. Medium or large surgery performed up to 3 months prior to inclusion.\n6. History of malignant neoplasm in the 12 months prior to screening (V-1).\n7. Uncontrolled coagulopathy or any hematological condition that contraindicates intramuscular injection.\n8. Presence of decompensated or uncontrolled chronic disease at the time of inclusion. At the investigator's discretion, participants with stable chronic disease may be included.\n9. Use of immunosuppressive medications in the 3 months prior to vaccination.\n10. History of antineoplastic chemotherapy treatment.\n11. Planning for the use of immunosuppressants or chemotherapeutic agents during the study period.\n12. Current use of corticosteroids at immunosuppressive doses. Immunosuppressive doses are considered to be ≥10 mg\u002Fday of prednisone (or equivalent) systemically for 14 days or more.\n13. Use of blood products in the 3 months prior to inclusion.\n14. Participation in another clinical study using an investigational product in the 12 months prior to inclusion.\n15. Pregnancy or lactation at the time of visit V0, or planning to become pregnant during the study period.\n16. Positive pregnancy test result at screening (visit V1) or on the day of vaccination (applicable to PEP).\n17. Presence of tattoos, scars, discoloration, or any skin alteration at the application site that, in the investigator's opinion, may interfere with the assessment of local reactogenicity.\n18. Any medical, psychological, or social condition that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the integrity of the data.\n19. Clinically significant changes in screening laboratory tests (visit V1):\n\n    * Hemoglobin ≤ 10.9 g\u002FdL;\n    * White blood cells \\\u003C 2,500 cells\u002Fmm³;\n    * Absolute neutrophils \\\u003C 1,000 cells\u002Fmm³;\n    * ESR above the upper limit of normal (ULN) \\>20 mm\u002Fh for men \\>30 mm\u002Fh for women;\n    * ALT, AST, GGT or ALP \\>1.25 × ULN;\n    * Total bilirubin \\>1.1 × ULN;\n    * Urea \\>1.1 × ULN;\n    * Creatinine \\>1.1 × ULN;\n    * Glycated hemoglobin \\>5.6%;\n    * Troponin I \\>1.1 × ULN;\n    * PT or aPTT \\>1.1 × ULN; • CPK above the ULN (men: \\>174 U\u002FL; women: \\>140 U\u002FL);\n    * C-reactive protein \\>1.0 mg\u002FdL.\n20. Resultado positivo em um ou mais exames de sorologia realizados na triagem.","ALL","18 Years","59 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a descriptive, open-label, multicenter, non-randomized, uncontrolled phase I clinical study to evaluate the safety, reactogenicity, and immunogenicity of the COVID-19 Vaccine (mRNA) - Bio-Manguinhos\u002FFiocruz at doses of 25 μg, 50 μg, and 100 μg in healthy adults aged 18 to 59 years. Each study cohort (25 μg, 50 μg, and 100 μg) will initially include a sentinel group of five participants, who will be included sequentially, one by one. This inclusion will allow for an initial integrated risk-benefit assessment, evaluating whether the data from the included participant maintain the risk within acceptable limits for progression.",[27],"Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus)",[29,30],"mRNA Platform","COVID-19","NOT_YET_RECRUITING","2026-06-08",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":21},"2026-07",{"date":39,"type":21},"2028-01",{"name":41,"class":42},"The Immunobiological Technology Institute (Bio-Manguinhos) \u002F Oswaldo Cruz Foundation (Fiocruz)","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100564290","phase-1-trial-lep-f1--gla-se-in-healthy-adult-in-areas-endemic-for-leprosy-100564290","NCT06627257","Trial LEP-F1 + GLA-SE in Healthy Adult in Areas Endemic for Leprosy","A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Participants in Areas Endemic for Leprosy","Inclusion Criteria:\n\n* Men and women between 18 and 55 years old.\n* They should be in good general health, confirmed by a medical history and physical examination, with negative clinical evaluation for leprosy.\n* Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on study vaccination days (D0, D28, and D56). They must not be breastfeeding and must use at least one method of contraception from the time of study enrollment (Day 0) through 30 days after the last injection if they have sex with men.\n* Screening laboratory tests with normal, within laboratory reference limits for: sodium, potassium, AST, ALT, total bilirubin, alkaline phosphatase, creatinine, glucose, total WBC count, hemoglobin and platelet count. Abnormal results may be repeated at the discretion of the Principal Investigator and\u002For sub-investigators, who may share doubts with the sponsor's Scientific Leader and if necessary, with the DSMB.\n* Negative serological tests for: HIV 1\u002F2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.\n* Normal or not clinically significant urinalysis as determined by the study doctor or designee. Abnormal results may be repeated at the discretion of the Principal Investigator.\n* Must be able to complete the study adverse events diary.\n* Must consent to participate in the study, be able and willing to make all evaluation visits, be accessible by telephone or home visits, and live in the region until study follow-up completion.\n* Having completed the primary vaccination course for Covid 19, at least 14 days before inclusion in the study. If 14 days have not been completed, the participant may be rescheduled for a new eligibility assessment\n\nExclusion Criteria:\n\n* History of infection with Mycobacterium leprae.\n* History of exposure to experimental products containing GLA-SE.\n* History of active tuberculosis or documented recurrence.\n* History of previous infection with other non-tuberculous mycobacteria.\n* Participation in another trial protocol and\u002For receipt of any trial products in the last 3 months prior to screening.\n* Treatment with immunosuppressive drugs (eg, oral or injectable steroids such as prednisone; high-dose inhaled steroids) or cytotoxic therapies (eg, chemotherapy or radiotherapy) within six months prior to screening.\n* Have received blood transfusion within the last 3 months prior to screening.\n* Donated blood products (platelets, whole blood, plasma, etc.) within the last month prior to screening.\n* Received any vaccine 1 month prior to screening or planned immunizations during the follow-up from D0 to D63 and D154 to D168.\n* History of autoimmune disease or other immunosuppressive causes.\n* History of any other uncompensated acute or chronic disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disease, uncontrolled hypertension) or use of medications that, in the opinion of the Principal Investigator, may interfere with safety or immunogenicity of the vaccine.\n* Rash, tattoos, or any other dermatological condition that may adversely affect the injection site of the vaccine or interfere with its evaluation.\n* Body mass index (BMI) ≥ 32.\n* Systemic arterial hypertension (systolic \\> 150 or diastolic \\> 95).\n* History of psychiatric illness with current medication use.\n* Alcohol or drug abuse in the last 6 months prior to screening.\n* Chronic smoker (1 pack or more per day).\n* History of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens.\n* Individuals who do not wish to cooperate with all procedures recommended in the study protocol.",true,"55 Years",{"count":53,"type":21},54,[24],"This is a phase 1b, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE compared to placebo administered as three intramuscular (IM) injections in adult participants aged 18 to 55.",[57],"Leprosy","2024-10-02",{"date":60,"type":35},"2024-10-04",{"date":62,"type":21},"2025-01-02",{"date":64,"type":21},"2026-08",{"name":41,"class":42},1,""]