[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429726":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":60,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":11,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Hvidovre University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Menveo + Bexsero","EXPERIMENTAL",null,[13],"Drug: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine",{"label":15,"type":10,"description":11,"interventionNames":16},"Prevenar13 + Pneumovax23",[17],"Drug: 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine",[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine","One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B (Bexsero®) at day 0 followed by another dose (0.5 ml) of each vaccine at day 60.",[9],[25],"Menveo® and Bexsero®",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine","One dose (0.5 ml) of pneumococcal conjugate vaccine (Prevenar13®) at day 0 and one dose (0.5 ml) of pneumococcal polysaccharide vaccine (Pneumovax23®) at day 60.",[15],[31],"Prevenar13® and Pneumovax23®",[33],{"name":34,"affiliation":35,"role":36},"Michaela Tinggaard, M.D.","Department of Infectious Diseases, Hvidovre Hospital","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":11,"email":41},"CONTACT","22326800","michaela.tinggaard@regionh.dk",[43],{"facility":44,"status":45,"city":46,"state":11,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hvidovre Hospital","RECRUITING","Hvidovre","2650","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],12.47708,55.64297,{"lat":54,"lon":53},[57],{"name":58,"role":39,"phone":59,"phoneExt":11,"email":41},"Michaela Tinggaard","+4522326800",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Thomas Benfield","Clinical professor","100429726","phase-4-safety-and-immunogenicity-following-meningococcal-and-pneumococcal-immunization-among-adult-people-living-with-hiv-100429726",false,"NCT04875819","Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV","Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial","MENPI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Seropositive for HIV-1\n* Recipient of ART\n* Plasma HIV-RNA \\\u003C 500 copies\u002Fml\n* Patients written consent obtained\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* History of meningococcal or pneumococcal vaccination\n* Allergies towards any of the vaccine components\n* Temperature \\> 38 ᵒC\n* Sign of bacterial infection\n* Previous known or suspected disease caused by N. meningitidis\n* Active AIDS associated illness\n* Active malignancy\n* End-stage renal or liver disease\n* Bleeding disorder\n* Recipient of any blood, blood products and\u002For plasma derivatives or any parenteral immunoglobulin preparation within the last month\n* Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)","ALL","18 Years",{"count":75,"type":76},55,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.\n\nParticipants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®\u002FPneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.\n\nImmunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.",[82,83,84],"Hiv","Meningococcal Infections","Pneumococcal Infections","2021-05-05",{"date":87,"type":88},"2021-05-06","ACTUAL",{"date":90,"type":88},"2021-04-28",{"date":92,"type":76},"2026-12",{"name":62,"class":6},1]