[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514023":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":28,"locations":37,"responsibleParty":65,"collaborators":67,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Boston University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Natural infection cohort",null,"Up to 200 symptomatic subjects (index cases) will be enrolled when they seek diagnosis for their symptoms of COVID-19 and have their SARS-CoV-2 infection confirmed. All their household contacts (anticipated 700) aged 5-75 years who provide consent (participants) will be examined for infection through two consecutive SARS-CoV-2 RT-PCR. Blood will be drawn from all participants who provide consent. Venous Blood will be drawn at the first visit (so called W0). A second collection is planned for 15 days after the first visit, a third collection at three months after the first visit, and subsequent collections are planned at six, nine, and 15 months after the first visit. At the visits one month, nine months and 15 months after the first visit, capillary blood will be collected. A stool sample will be collected for diagnosis of intestinal parasites.",{"label":13,"type":10,"description":14,"interventionNames":10},"Vaccine cohort","Up to 600 subjects 18-75 years will be recruited when they attend a vaccination clinic at one of the study health centers in Blantyre to receive their 1st dose of the AstraZeneca (AZ) or the Johnson and Johnson (JJ) COVID-19 vaccines. Venous blood will be collected at that time. For AZ vaccinees, at their 2nd vaccine dose, about 90 days after the 1st dose, they will be given a stool sample container. JJ vaccinees will receive the stool sample container when they receive the first vaccine dose. Two weeks after completion of the primary regimen (2nd dose of the AZ \\[M3.5\\] and 1st dose of the JJ vaccines \\[M0.5\\]), venous blood draws will be repeated and stool containers will be collected. Subsequent visits\u002Fprocedures will happen at one month thereafter (M4.5 for AZ and M1.5 for JJ), and 3, 6, 9, and 12 months after the primary regimen. Venous blood will be collected at the visit 1.5, 3, 6, and 12 months after the primary regimen and capillary blood will be collected at the other visits.",[16,20,23,25],{"name":17,"affiliation":18,"role":19},"Clarissa Valim, MD ScD","BU School of Public Health, Department of Global Health","PRINCIPAL_INVESTIGATOR",{"name":21,"affiliation":22,"role":19},"Don Mathanga, MBBS PhD","Kamuzu University of Health Sciences, Malaria Alert Center, Malawi",{"name":24,"affiliation":18,"role":19},"Patricia Hibberd, MD PhD",{"name":26,"affiliation":27,"role":19},"James Beeson, MBBS PhD","Burnet Institute, Australia",[29,33],{"name":17,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","(617) 414-1260","cvalim@bu.edu",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Aditi S Kothari, BDS MDSc MPH","(617) 358-2441","aditi@bu.edu",[38,52],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":10},"BU School of Public Health, Global Health Department","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02118","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},{"facility":53,"status":54,"city":55,"state":10,"zip":10,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Health center","RECRUITING","Blantyre","Malawi","MW",{"type":47,"coordinates":59},[60,61],35.00854,-15.78499,{"lat":61,"lon":60},[64],{"name":21,"role":19,"phone":10,"phoneExt":10,"email":10},{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68,71,73],{"name":69,"class":70},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":72,"class":6},"Kamuzu University of Health Sciences",{"name":74,"class":6},"Burnet Institute","100514023","covid-19-transmission-and-morbidity-in-malawi-100514023",false,"NCT05973084","COVID-19 Transmission and Morbidity in Malawi","COVID-TMM","Inclusion Criteria Index Cases\n\n1. Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test;\n2. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers for the following 6 months;\n3. Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age;\n4. Has not received a SARS-CoV-2 vaccine in the previous 3 months\n5. Willingness to comply with study procedures and visits, and provides informed consent.\n\nHousehold Contacts of the Confirmed SARS-CoV-2 Case\n\n1. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers in the following 6 months;\n2. Willingness to comply with study procedures and follow-up visits and provides informed consent.\n3. Has not received a SARS-CoV-2 vaccine in the previous 3 months\n\nVaccinees\n\n1\\) Aged 18 years to 75 years; 2) Willingness to receive the primary regimen of the AZ and\u002For JJ vaccines 2) Not in the other 2 cohorts; 4) Willingness to comply with study procedures and follow-up visits and provides informed consent.\n\n5\\) Has not received a prior dose of a SARS-CoV-2 vaccine\n\nExclusion Criteria Index Cases\n\n1. Conditions that precludes from adherence to the visit schedule;\n2. 50% or more of household members decline to participate.\n3. Pregnancy at the enrollment visit\n4. Long term use of cotrimoxazole prophylaxis\n\nHousehold Contacts of the Confirmed SARS-CoV-2 Case\n\n1. Conditions that preclude adherence to the visit schedule.\n2. Participants with 2 consecutive negative SARS-CoV-2 RT-PCRs will be excluded from visits after M1.\n3. Pregnancy at the enrollment visit\n4. Long term use of cotrimoxazole prophylaxis\n\nVaccinees\n\n1. Conditions that preclude adherence to the visit schedule.\n2. Pregnancy at the enrollment visit\n3. Long term use of cotrimoxazole prophylaxis","ALL","5 Years","75 Years",{"count":86,"type":87},1500,"ESTIMATED","OBSERVATIONAL","SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination.\n\nStudy objectives\n\n1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi\n2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses.\n3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections.\n4. Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination.\n5. Assess whether malaria and intestinal parasite infections, chronic\u002Fmild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism.",[91,92],"SARS CoV 2 Infection","SARS CoV 2 Vaccination",[94,95,96,97,98,99,100,56,101],"Natural infection","Immune phenotypes","Innate immunity","SARS CoV 2 adaptive immunity","SARS CoV 2 antibody response","Vacinees","Household contacts","Sub Saharan Africa","2026-05-26",{"date":104,"type":105},"2026-05-28","ACTUAL",{"date":107,"type":105},"2023-01-17",{"date":109,"type":87},"2028-03",{"name":5,"class":6},2]