Covid 19 transmission and morbidity in Malawi
Abstract
COVID Transmission and Morbidity in Malawi (COVID-TMM)
Type of research study: Prospective cohort study
The problem to be studied: To assess whether infection rates and morbidity of SARS CoV-2, as well as acquisition and duration of antibody-induced
immunity in Malawi may be impacted by a trained and/or
tolerant innate immunity, resulting in particular from malaria,
helminth infections, anemia and nutrient deficiency
Population: A total of 1,200 participants will be recruited in Malawi (300 in
the vaccine cohort and 900 in the natural infection cohort).
Participants will have 5 to 75 years of age and any sex.
Objectives: 1. To determine the risk and predictors of infection and
disease among contacts of SARS-CoV-2 infected
subjects in Malawi.
2. To determine whether innate immune responses lower
the risk of SARS-CoV-2 infection and disease, and
acquisition and duration of vaccine responses.
3. To assess whether alterations in innate immune
responses relevant to SARS-CoV-2 are associated with
malaria or intestinal parasite infections.
4. To assess the acquisition and longevity of Abs and
cellular adaptive responses elicited by SARS-CoV-2
infection and vaccination.
5. To 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.
Methodology: We will enroll up to 1,200 participants aged 5 to 75 years from
four peri-urban health centres in Blantyre district Malawi.
SARS-CoV-2 symptomatic individuals (index cases) and their
household contacts and recently vaccinated individuals will be
selected and screened for eligibility.
Specifically, two cohorts will be enrolled:
a) Natural infection cohort– 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 years or
older will be examined for infection. Blood will be
drawn from all eligible subjects who provide consent.
One week later, SARS-CoV-2 testing will be repeated
in household contacts who tested negative in the first
visit. Individuals who test negative after this second
test will be excluded from visits that take place more
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than 2 weeks after enrollment. Participants will be
followed up for 18 months after enrollment.
b) Vaccine cohort – 300 subjects aged 15-75 years will
be recruited when they attend a vaccination clinic at
any of the study sites for their first dose of the
AstraZeneca or the Johnson and Johnson vaccines.
Venous blood will be collected at that time. For
AstraZeneca vaccinees, when they come for their 2nd
vaccine dose, approximately 90 days after the 1st
vaccine dose, they will receive material for collection of
a stool sample. Johnson and Johnson vaccinees will
receive the container for collection of the stool sample
when they receive the first vaccine dose. Two weeks
after completion of the primary regimen (2
nd dose of
the AstraZeneca and 1st dose of the Johnson and
Johnson vaccines), a venous blood draw will be
repeated. Subsequent visits and procedures will
happen at the same schedule of the “Natural Infection”
cohort.
Venous blood samples from participants in both the natural
infection and vaccine cohort will be used to quantify innate
immune phenotypes and stimulation, quantification of
micronutrients, quantification of antibody magnitude and
function, quantification of T cell phenotypes and stimulation,
and detection of malaria infection.
Total Study Duration: 5 years
Subject Participation
Duration:
18 months after the first visit.
Expected findings and
dissemination
Our findings will help understand the lower morbidity of SARS CoV-2 that has been registered in Malawi and other sub Saharan African countries and the effect that malaria, helminth
infection, anemia, and nutrient deficiency may have on SARS CoV-2 in Malawi. Furthermore, we will assess acquisition and
duration of responses to infection and immunity in Malawi.
Our study may inform vaccination policy in Malawi by identifying
high risk groups, optimal target coverage, and determining
intervals at which booster doses should be provided.
The results will be distributed and discussed with the local
community, Ministry of Health, Kamuzu University of Health
Sciences, and the College of Medicine Research Ethics
Committee (COMREC). Main findings will be presented in
international conferences, College of Medicine Research
Dissemination Conference, and published in international peer reviewed journals.
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