[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658091":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":39,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":68,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":102,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Federal University of Minas Gerais","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Celular immunogenicity","Number and percentage of the various vaccine-induced mononuclear and polymorphonuclear populations, as assessed by flow cytometry, comparing age groups.","3 years",[14,18,21,23],{"measure":15,"description":16,"timeFrame":17},"Safety evaluation","To evaluate the incidence of adverse events, particularly adverse events of special interest (Chikungunya-like adverse events \\[CLARs\\], carditis, encephalitis, and grade 3 or higher adverse events), up to 60 days after vaccination.","60 days",{"measure":19,"description":20,"timeFrame":12},"Neutralizing antibodies duration","Titer of antibodies capable of neutralizing a Brazilian Chikungunya strain and the vaccine strain in a plaque neutralization assay.",{"measure":22,"description":20,"timeFrame":12},"Immunological profile evaluation",{"measure":24,"description":25,"timeFrame":12},"Immunological crossover","Correlation matrix-in the form of correlograms or heatmaps-of the humoral and cellular response.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","PREVENTION",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34],{"label":35,"type":36,"description":35,"interventionNames":37},"IXCHIQ vaccine","EXPERIMENTAL",[38],"Biological: IXCHIQ vaccine",[40],{"type":41,"name":35,"description":42,"armGroupLabels":43,"otherNames":26},"BIOLOGICAL","Live-attenuated monovalent vaccine against Chikungunya virus - IXCHIQ",[35],[45],{"name":46,"affiliation":5,"role":47},"Mauro M Teixeira, MD, Phd","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},"Pedro R J Almeida, MD, MSc","CONTACT","+55 31 995166160","pedrojesus@ufmg.br",[55],{"facility":56,"status":26,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":26},"Clinical Research Unit","Belo Horizonte","Minas Gerais","30750140","Brazil","BR",{"type":63,"coordinates":64},"Point",[65,66],-43.93778,-19.92083,{"lat":66,"lon":65},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Mauro Martins Teixeira","MD, Phd",[73],{"name":74,"class":75},"FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais","UNKNOWN","100658091","phase-2-evaluation-of-ixchiq-vaccine-immunogenicity-100658091",false,"NCT07846293","Evaluation of IXCHIQ® Vaccine Immunogenicity","Evaluation of Immunogenicity and Duration of Immunity of the IXCHIQ® Vaccine Against CHIKV","IMUNO-CHIQ","Inclusion criteria:\n\n* The participant or guardian understands the procedures and requirements, and is willing and able to provide informed consent for full participation in the study;\n* Individuals of both sexes aged 12 to 59 years.\n\nExclusion Criteria:\n\n* Participants under 12 years of age or 60 years of age or older;\n* Those with any contraindication identified in Ministry of Health Technical Note No. 9\u002F2026-CGFAM\u002FDPNI\u002FSVSA\u002FMS (https:\u002F\u002Fwww.gov.br\u002Fsaude\u002Fpt-br\u002Fcentrais-de-conteudo\u002Fpublicacoes\u002Fnotas-tecnicas\u002F2026\u002Fnota-tecnica-no-9-2026-cgfam-dpni-svsa-ms.pdf - Technical Note: Guidelines for monitoring the safety of the Chikungunya vaccine used during the pilot vaccination strategy in Brazil - 2026);\n* Participants unavailable to attend the planned study visits;\n* Participants who do not agree to sign the Informed Consent Form (ICF);\n* Positive β-hCG test on the day of vaccination, for women of reproductive potential;\n* Participants who are pregnant or planning to become pregnant within the 3 months following the vaccine dose;\n* Participants who are breastfeeding;\n* Participants with a known or suspected immune system defect that could influence the immune response to the vaccine, such as congenital or acquired immunodeficiency-including HIV infection, post-organ transplant status, or immunosuppressive therapy within 4 weeks prior to Visit 1. Immunosuppressive therapy is defined as the chronic administration of prednisone (more than 14 days) or an equivalent at a dosage of ≥2 mg\u002Fkg\u002Fday during the 4 weeks prior to study entry. Note: radiotherapy or cytotoxic immunosuppressive drugs\u002Fmonoclonal antibodies within the previous 3 years; topical and inhaled steroids are permitted.\n* Any clinical instability identified by the attending physician that could place the participant at risk.",true,"ALL","12 Years","59 Years",{"count":89,"type":90},75,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","The goal of this clinical trial is to evaluate the quality and duration of the immune response against chikungunya virus elicited by the IXCHIQ® vaccine in healthy adults and adolescents. The main questions it aims to answer are:\n\nIs the cellular immune response elicited by IXCHIQ® adequate for Chikungunya prevention? Is the IXCHIQ® vaccine safe? How does the immune response elicited by IXCHIQ® behave at the different time points evaluated?\n\nParticipants will:\n\nReceive the IXCHIQ® vaccine; Be evaluated by medical personnel and have a blood sample taken on days 3, 7, 30, 180, and 720 after vaccination; Be contacted by phone 60 days after vaccination.",[96,97],"Healthy Adult","Healthy Adolescents",[99,100,101],"IXCHIQ","Chikungunya","Immunogenicity","NOT_YET_RECRUITING","2026-09-22",{"date":105,"type":106},"2026-09-29","ACTUAL",{"date":108,"type":90},"2026-09-24",{"date":110,"type":90},"2030-07",{"name":70,"class":6},1]