[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636159":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":34,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":10,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"St George's, University of London","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Women not living with HIV, who received the GBS6 vaccine GBS6 Clinical Trial in Kampala, Uganda",null,"Women not living with HIV, who received the GBS6 vaccine in the \"a placebo-controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants\" (GBS6) Clinical Trial in Kampala, Uganda.\n\nThe GBS6 trial enrolled 300 pregnant women between October 2022 and July 2023. Of these, 150 participants (75 living with HIV and 75 not living with HIV) were randomized to receive either the GBS6 vaccine (a capsular polysaccharide conjugate vaccine targeting the six most common disease-causing GBS serotypes) or placebo (normal saline).\n\nFor this follow-up study, only participants who received the GBS6 vaccine and are not living with HIV (n=75) will be contacted via telephone using the contact details provided in the GBS6 trial records. Each consenting participant will attend a single study visit for serum collection.",[13],"Other: Collection of 50mls of blood",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Collection of 50mls of blood","50mls of blood will be collected from all participants who give consent.",[9],[20],{"name":21,"affiliation":22,"role":23},"Kirsty Le Doare","City St George's, University of London","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Mary Kyohere","CONTACT","+447490390327","mkyohere@sgul.ac.uk",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Madeleine Cochet","+442087255214","mcochet@sgul.ac.uk",[35],{"facility":36,"status":37,"city":38,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"MUJHU Care Ltd, Kampala","RECRUITING","Kampala","Uganda","UG",{"type":42,"coordinates":43},"Point",[44,45],32.58219,0.31628,{"lat":45,"lon":44},[48,52],{"name":49,"role":27,"phone":50,"phoneExt":10,"email":51},"Zakaria Mukasa, Dr","+256 782 201308","zmukasa@mujhu.org",{"name":53,"role":23,"phone":10,"phoneExt":10,"email":10},"Robert Mboizi",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100636159","multiplex-immunoassay-quality-assurance-panel-100636159",false,"NCT07562061","mulTiplex Immunoassay qualiTy assuRance Panel","Development of Group B Streptococcus Quality Assurance Panel for the GASTON Multiplex Anti-CPS IgG Immunoassay.","TITRE","Inclusion Criteria:\n\n* HIV-uninfected women who received the GBS6 vaccine during pregnancy and completed the whole period of study participation.\n* Reachable by phone\n* Willing and able to provide consent.\n* Willingness to provide a blood sample.\n\nExclusion Criteria:\n\n* Receipt of blood\u002Fplasma transfusion in the last 3 months\n* Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids.\n* Women who will test positive for Syphilis or HIV at screening\n* Current alcohol abuse or illicit drug use, or with a psychiatric condition\n* Major illness of the mother that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in the study, including but not limited to the following:\n\nI. heart disease II. severe anaemia (Hemoglobin level less than 7.0g\u002FdL)","FEMALE",{"count":66,"type":67},50,"ESTIMATED","OBSERVATIONAL","Collection of serum from women not living with HIV, who received the GBS6 vaccine in the \"a placebo-controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants\" (GBS6) Clinical Trial in Kampala, Uganda, for the Development of Group B Streptococcus quality assurance panel for the GASTON multiplex anti-CPS IgG immunoassay",[71],"Group B Strep Infection","2026-04-24",{"date":74,"type":75},"2026-05-01","ACTUAL",{"date":77,"type":75},"2026-03-27",{"date":79,"type":67},"2027-01",{"name":5,"class":6},1]