COVID-19 Transmission and Morbidity in Malawi

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. Study objectives 1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi 2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses. 3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections. 4. Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination. 5. Assess whether malaria and intestinal parasite infections, chronic/mild 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.

NCT Number	NCT05973084
Lead Sponsor	Boston University Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Kamuzu University of Health Sciences, Burnet Institute
Conditions	SARS CoV 2 Infection, SARS CoV 2 Vaccination
Enrollment	1,500 participants
Start Date	2023-01-17
Primary Completion	2028-03 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-05-28