[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Butantan Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"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":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100580812","phase-1-safety-and-immunogenicity-of-the-monovalent-influenza-vaccine-a-h5n8-inactivated-fragmented-and-adjuvanted-in-adults-and-older-adults-100580812",false,"NCT06842173","Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults","Randomized, Double-Blind, Placebo-Controlled Phase I\u002FII Clinical Trial To Evaluate The Safety And Immunogenicity Of The Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) From Instituto Butantan, In Adults And The Older Adults","Inclusion Criteria:\n\n1. Males and non-pregnant females aged ≥ 18 years at the time of the first study vaccination.\n2. Be in good health and clinically stable (defined as having no pre-existing health condition or having a pre-existing health condition that has not required a change in treatment or hospitalization for worsening of disease in the 3 months prior to the date of the first study vaccination).\n3. Agree to participate in the study and provide written informed consent prior to the initiation of any study procedures.\n4. Be able and willing to comply with all study procedures, including completing Participant Diaries, collecting blood samples, and being available for scheduled study visits and contacts.\n5. For females of childbearing potential, have a negative pregnancy test prior to the first study vaccination.\n6. For women of childbearing potential, be willing to use effective contraceptive measures during the screening visit until at least 30 days after the second study vaccination.\n\nExclusion Criteria:\n\n1. Having received any vaccine (including seasonal influenza) 28 days prior to the date of the first study vaccination or having any vaccination in the period from the first vaccination to the immune response assessment visit after the last vaccination.\n2. Known hypersensitivity or allergy to eggs, chicken proteins, squalene-based adjuvants, or any other component of the investigational product.\n3. History of serious adverse reaction or anaphylaxis to any previous influenza vaccine (licensed or not).\n4. Having received any influenza A\u002FH5 vaccine or history of exposure to avian influenza A\u002FH5.\n5. Presence of a bleeding disorder or any condition that contraindicates intramuscular injection.\n6. Having received immunoglobulin, blood, or any blood-derived product in the 3 months prior to the date of the first study vaccination or having had immunoglobulin or blood-derived product administered during the entire follow-up of the study.\n7. Having received a solid organ, bone marrow, or stem cell transplant.\n8. Having a history of asplenia (anatomic or functional).\n9. Having any confirmed or suspected immunosuppressive or immunodeficiency condition, including a history of human immunodeficiency virus (HIV) infection.\n10. Having a history of Guillain-Barré syndrome or other demyelinating disease.\n11. Having a history of neurological disease, seizures, or progressive or severe neurological disorder.\n12. History of malignant neoplasm or previous history of malignant neoplasm being disease-free for 5 years at the date of the first study vaccination (with the exception of basal cell carcinoma of the skin), autoimmune disease (including type 1 diabetes mellitus), liver cirrhosis and renal failure.\n13. History of significant, progressive or decompensated chronic disease in the 3 months prior to the date of the first study vaccination (complicated type 2 diabetes mellitus, liver disease, kidney disease, heart disease, advanced arteriosclerotic disease or lung disease such as oxygen-dependent chronic obstructive pulmonary disease, among others).\n14. Having received or using radiotherapy, chemotherapy, cytotoxic drugs, immunosuppressants or immunomodulators in the 6 months prior to the date of the first study vaccination.\n15. Use of systemic corticosteroids (oral or parenteral) in the 3 months prior to the date of the first study vaccination, at an immunosuppressive dose equivalent to a dose of ≥ 20 mg of prednisone per day for ≥ 14 days or a cumulative dose of ≥ 280 mg. Topical use of corticosteroids (e.g., cream, eye drops, inhalation and intranasal sprays) is permitted, within the dosage indicated on the product label.\n16. Presenting a behavioral, cognitive disorder\u002Fdisorder or psychiatric illness that, in the opinion of the Investigator, may interfere with the ability to participate in the study.\n17. Infection with the human immunodeficiency virus (HIV), hepatitis B or hepatitis C.\n18. Abuse of alcohol or drugs in the 12 months prior to the date of the first study vaccination, that may interfere with the ability to participate in the study.\n19. Body mass index (BMI) ≥ 35 kg\u002Fm2 on the date of the first study vaccination.\n20. Clinically significant abnormalities in the general physical examination.\n21. Major surgery or surgery with the use of general anaesthesia planned to occur in the period from the first vaccination to the visit to assess the immune response after the last vaccination.\n22. Women who are pregnant, breastfeeding or planning to become pregnant during the 30 days after the last vaccination in the study.\n23. Laboratory parameter values at the screening visit equal to or greater than grade 2 will be considered as a criterion for exclusion from participation in the study.\n24. Presenting any clinically significant condition or situation that, in the opinion of the Investigator, represents a risk to the participant health or may interfere with the evaluation of the study objectives, the schedule of visits, participation in or completion of the study (such as planned travel or change of residence, among others).\n25. Having participated in another clinical trial involving an experimental product, with less than three months between the completion of that follow-up and the planned date of the first vaccination in this study, or plans to enter a clinical study during the period of this study.\n26. Institutionalized individual (people residing in long-term care, assistance or health care institutions and deprived of liberty).\n\naa. Being related to or part of the research centre staff or employee directly involved in the study.",true,"ALL","18 Years",{"count":20,"type":21},700,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study aims to demonstrate the safety and immunogenicity of two formulations of the monovalent influenza vaccine candidate A (H5N8) (inactivated, fragmented, and adjuvanted with IB160) from the Instituto Butantan in adults and older adults, to be developed for situations of pandemic, epidemic or outbreak of avian type A\u002FH5 in humans, in the context of pandemic preparedness.",[28],"Avian Influenza A Virus",[30,31,32,33],"Influenza A Virus Subtype H5N8","Avian Influenza","Safety","Immunogenicity","RECRUITING","2026-04-01",{"date":37,"type":38},"2026-04-02","ACTUAL",{"date":40,"type":38},"2025-09-10",{"date":42,"type":21},"2027-10-10",{"name":44,"class":45},"Butantan Institute","OTHER_GOV",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100590926","phase-3-trial-to-evaluate-the-immunogenicity-and-safety-of-the-co-administration-of-live-attenuated-dengue-and-chikungunya-vaccines-compared-to-separate-administration-in-adults-aged-18-to-59-years-100590926","NCT06973772","Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration in Adults Aged 18 to 59 Years.","Phase 3b, Multicenter, Randomized, Controlled, Double-Blind Clinical Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines in Adults Aged 18 to 59 Years.","Inclusion Criteria:\n\n1. Male or female adults aged 18 to 59 years at the time of vaccination.\n2. Signed informed consent by the participant or their legal representatives.\n3. Ability to understand, based on the investigator's assessment, and agree to comply with all study procedures, including blood collection.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial within 28 days prior to screening or planned participation in another clinical study during the trial period.\n2. Pre-existing unstable health condition. An unstable health condition is defined as a disease requiring a change in treatment or hospitalization due to disease worsening within 90 days prior to screening.\n3. Vaccination within 14 days prior to screening with any inactivated vaccine or within 28 days prior to screening with any live attenuated vaccine, or planned vaccination with any vaccine up to 28 days after study vaccination.\n4. Known hypersensitivity to any component of the vaccines.\n5. Thrombocytopenia or bleeding disorders that contraindicate intramuscular vaccination or venipuncture for blood collection.\n6. Receipt of immunoglobulins, blood, or blood products within 180 days prior to screening.\n7. Altered immunocompetence (immunosuppression, immunodeficiency, or immunocompromise) primary or secondary due to: Clinical conditions (including but not limited to renal failure, liver failure with cirrhosis, heart failure class III or IV according to the New York Heart Association, HIV infection, and asplenia).\n8. Use of systemic corticosteroids (oral, intravenous, or intramuscular) at a dose equivalent to ≥20 mg\u002Fday of prednisone for more than 14 days or a cumulative dose greater than 280 mg within the last 90 days prior to screening. Topical, inhaled, and intranasal corticosteroids are allowed. Intermittent use (a single dose within the last 30 days prior to screening) of intra-articular corticosteroids is also allowed.\n9. Receipt of antineoplastic agents, immunosuppressants, immunomodulators, or radiotherapy within the last 180 days prior to screening.\n10. Malignancy at the time of screening or a history of malignancy with \\\u003C5 years of disease-free status at screening (except for basal cell carcinoma of the skin and localized prostate cancer under active surveillance).\n11. Abuse of alcohol and illicit drugs within the past 12 months before screening that may compromise study compliance, at the investigator's discretion.\n12. Being part of the study team, having a first-degree relative (parents, children, in-laws, stepchildren, sons-in-law, or daughters-in-law) or living in the same household as a study team member.\n13. Any other clinical condition that, in the investigator's opinion, may interfere with the study results or pose an additional risk to the participant due to study inclusion.\n14. Prior exposure to dengue and chikungunya viruses, i.e., non-reactive IgM and IgG as screened by specific ELISA for both viruses. In case of doubt or indeterminate ELISA results, at least two consecutive samples will be collected. If doubt persists after two test collections, the participant will be excluded.\n15. For female participants of childbearing potential: Pregnancy (confirmed by a positive β-hCG test), breastfeeding, or intention to engage in sexual activity with reproductive potential without using a contraceptive method for 90 days following vaccination.\n16. Previous receipt of any dengue or chikungunya vaccine.","59 Years",{"count":56,"type":21},900,[58],"PHASE3","This randomized, controlled, double blind trial aims at assessing the safety and immunogenicity profiles of the co-administered Live Attenuated Dengue and Chikungunya vaccines comparatively to the isolated administration, in the adult population aged 18 to 59 years without prior exposure to either arbovirus.",[61,62],"Dengue","Chikungunya",[64,65,66],"dengue","chikungunya","coadministration regimen","NOT_YET_RECRUITING","2026-03-05",{"date":70,"type":38},"2026-03-06",{"date":72,"type":21},"2026-03-31",{"date":74,"type":21},"2026-10",{"name":44,"class":45},7,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":16,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":99,"locationsCount":46},"100584638","phase-3-butantan-dv-vaccine-in-elderly-populations-den-04-ib-100584638","NCT06891950","Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)","Phase 3B, Double-blind, Randomized Study to Evaluate the Safety and Non-inferiority of the Humoral Immune Response of the Butantan Dengue Vaccine in Participants Aged 60 to 79 Years Compared to Participants Aged 40 to 59 Years","DEN-04-IB","Inclusion Criteria:\n\n* a. Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever;\n\n  b. Agree to periodic contact by telephone, electronic means, and home visits and to the research center;\n\n  c. Participants with reproductive potential must be using some effective contraceptive method at screening and continue using it for up to 90 days after the intervention; except in cases where the volunteer declares that she is not at risk of becoming pregnant, either by not engaging in sexual activities or by engaging in them in a non-reproductive manner, up to 90 days after vaccination;\n\n  d. Demonstrate intent to participate in the study, documented by the participant's signature of the informed consent form, as well as the study procedures, including completing the Participant Diaries, blood collection, and being available for scheduled study visits and contacts.\n\nExclusion Criteria:\n\n* a. For female participants with reproductive potential: pregnancy (confirmed by positive β-hCG test), breastfeeding or manifest intention to have sexual practices with reproductive potential without using a contraceptive method in the 90 days following vaccination;\n\n  b. Planned donation of blood, semen or eggs in the 90 days following vaccination;\n\n  c. Evidence of active uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease according to anamnesis or physical examination, at the discretion of the investigator;\n\n  d. Diseases that compromise the immune system, including: decompensated diabetes mellitus, active neoplasms or history of neoplasms in the last five years (except basal cell carcinoma), congenital or acquired immunodeficiencies (including HIV\u002FAIDS), solid organ transplants (heart, liver, pancreas, lung, kidney) or uncontrolled autoimmune diseases according to anamnesis or physical examination, as well as a history of liver failure, heart failure or terminal chronic kidney disease or dialysis;\n\n  e. Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his\u002Fher medical representative, affects the potential participant's ability to understand and comply with the requirements of the study protocol;\n\n  f. Any abuse of alcohol or drugs in the last 12 months prior to enrollment in the study that has caused medical, professional, or family problems, as indicated by the clinical history;\n\n  g. History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;\n\n  h. History of asplenia;\n\n  i. Participation in another clinical trial with administration of an investigational product during the six months prior to enrollment in the study or scheduled participation in another clinical trial in the 12 months following enrollment;\n\n  j. Previous participation in a dengue vaccine evaluation study or previous exposure to dengue vaccine;\n\n  k. Use of immunosuppressive therapies six months prior to enrollment in the study or their scheduled use in the 12 months following enrollment. The following immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiotherapy, immunosuppressants to induce tolerance to transplants, monoclonal antibody therapy for the treatment of rheumatological diseases, among others;\n\n  l.Having received an immunosuppressive dose of corticosteroid in the last three months prior to inclusion in the study or administration of an immunosuppressive dose of corticosteroid for the 12 months following inclusion in the study. The dose of corticosteroid considered immunosuppressive is the equivalent of prednisone at a dose of 20 mg\u002Fday, for adults, for 14 days (cumulative dose equivalent to at least 280 mg of prednisone). Continuous use of topical or nasal corticosteroid is not considered immunosuppressive;\n\n  m. Having received blood products (transfusions or immunoglobulins) in the last three months prior to inclusion in the study, or scheduled administration of blood products or immunoglobulin in the 12 months following inclusion in the study;\n\n  n. Fever, suspected or measured, in the 72 hours prior to vaccination or axillary temperature ≥ 37.8°C on the day of vaccination (inclusion may be postponed until the potential participant has been fever-free for 72 hours);\n\n  o. Having received a live attenuated virus vaccine in the last 28 days or an inactivated vaccine in the last 14 days prior to inclusion in the study, or having been immunized within 12 months of inclusion in the study;\n\n  p. Any other condition that, in the opinion of the principal investigator or his\u002Fher medical representative, may jeopardize the safety or rights of a potential participant or that prevents him\u002Fher from complying with this protocol.","40 Years","79 Years",{"count":88,"type":21},997,[58],"This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.",[61],[93,94],"dengue vaccine","elderly population",{"date":70,"type":38},{"date":97,"type":38},"2026-03-03",{"date":74,"type":21},{"name":44,"class":45},""]