Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria Index Cases 1. Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test; 2. 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; 3. Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age; 4. Has not received a SARS-CoV-2 vaccine in the previous 3 months 5. Willingness to comply with study procedures and visits, and provides informed consent. Household Contacts of the Confirmed SARS-CoV-2 Case 1. 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; 2. Willingness to comply with study procedures and follow-up visits and provides informed consent. 3. Has not received a SARS-CoV-2 vaccine in the previous 3 months Vaccinees 1\) Aged 18 years to 75 years; 2) Willingness to receive the primary regimen of the AZ