Actively Recruiting
COVID-19 Transmission and Morbidity in Malawi
Led by Boston University · Updated on 2026-05-28
1500
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating why the impact of SARS-CoV-2 in sub-Saharan African countries, specifically Malawi, appears milder compared to Europe and the Americas. The study aims to understand how innate immune responses, malaria, intestinal parasites, undernutrition, and anemia influence infection risk, symptom progression, transmission, and responses to SARS-CoV-2 vaccination. They are assessing immune responses and vaccine effects in various groups to better understand susceptibility and immunity in this population. The study includes up to 200 symptomatic individuals confirmed with SARS-CoV-2 infection, their household contacts (about 700), and up to 600 vaccine recipients aged 5 to 75 years. Participants undergo multiple visits for blood and stool sample collection over a follow-up period of up to 1.5 years. Vaccine recipients receive either the AstraZeneca or Johnson and Johnson vaccines, with samples collected at specific intervals after vaccination to monitor immune responses. Participants will have blood drawn at baseline and multiple follow-up visits to measure antibody levels, cellular immune responses, and markers of inflammation. Stool samples will be collected to diagnose intestinal parasites. Researchers will also monitor infection rates, symptom duration, and vaccine responses. The study will track these measures over time to assess how infections and vaccinations affect immunity and disease outcomes, with the overall participation lasting up to 15 months after initial enrollment.
CONDITIONS
Brief Title
COVID-19 Transmission and Morbidity in Malawi
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presents with symptoms of COVID-19 and has infection confirmed by RT-PCR or rapid antigen test (index cases)
- Aged 5 to 75 years and plans to live in Blantyre catchment area for at least 6 months
- Confirmed SARS-CoV-2 infection and shares a household with eligible individuals (index cases)
- Has not received a SARS-CoV-2 vaccine in the previous 3 months (index cases and household contacts)
- Willingness to comply with study procedures and provides informed consent
- Household contacts aged 5 to 75 years living in Blantyre catchment area and willing to comply with study visits
- Vaccinees aged 18 to 75 years willing to receive AstraZeneca or Johnson and Johnson vaccines
- Has not received any prior SARS-CoV-2 vaccine dose (vaccinees)
You will not qualify if you...
- Conditions preventing adherence to visit schedule
- 50% or more of household members decline participation (index cases)
- Pregnancy at enrollment visit
- Long-term use of cotrimoxazole prophylaxis
- Participants with 2 consecutive negative SARS-CoV-2 RT-PCRs excluded from visits after month 1 (household contacts)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1.5 years
Participants are observed with repeated blood and stool sample collections to assess immune responses and infection status over time.
Multiple visits including blood and stool sample collections at baseline, 2 weeks, 15 days, 1 month, 3 months, 6 months, 9 months, 12 months, and 15 months depending on cohort
Trial Site Locations
Total: 2 locations
1
BU School of Public Health, Global Health Department
Boston, Massachusetts, United States, 02118
Active, Not Recruiting
2
Health center
Blantyre, Malawi
Actively Recruiting
Research Team
C
Clarissa Valim, MD ScD
A
Aditi S Kothari, BDS MDSc MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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