COVID-19 Transmission and Morbidity in Malawi Study
This observational study in Malawi is looking into why COVID-19 (SARS-CoV-2) has had a different impact there compared to other parts of the world. Researchers want to understand how factors like malaria and other parasitic diseases might affect your body's immune response to COVID-19 infection and vaccination. They are studying people who have COVID-19 symptoms and their household contacts, as well as people who have received COVID-19 vaccines. The study aims to see how likely contacts are to get infected, how long protective antibodies last, and changes in certain immune cells. The goal is to enroll about 1500 participants, including 200 symptomatic individuals, 700 household contacts, and 600 vaccinees. The study status is currently unclear.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to enroll about 1500 participants, including individuals with COVID-19 symptoms, their household contacts, and vaccinated individuals.
- What's involved
- Participants will be followed for up to 1.5 years. Researchers will assess immune responses at baseline, 2 weeks, and up to 15 months, including antibody levels and immune cell changes.
- Compensation
- Not stated in the trial record.
- Follow-up
- Infected participants and vaccinees will be followed for up to 1.5 years to assess antibody responses and memory B cells.
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COVID-19 Transmission and Morbidity in Malawi
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Clarissa Valim, MD ScD · PRINCIPAL_INVESTIGATOR · BU School of Public Health, Department of Global Health
- Don Mathanga, MBBS PhD · PRINCIPAL_INVESTIGATOR · Kamuzu University of Health Sciences, Malaria Alert Center, Malawi
- Patricia Hibberd, MD PhD · PRINCIPAL_INVESTIGATOR · BU School of Public Health, Department of Global Health
- James Beeson, MBBS PhD · PRINCIPAL_INVESTIGATOR · Burnet Institute, Australia
Who to contact
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What this trial measures
- Risk of asymptomatic infection among contacts who acquire infectionup to 2 weeks
Proportion of household members who acquire an asymptomatic (vs. symptomatic) infection among household contacts of an index case
- Duration of neutralizing antibody (NAb) responses against two virusesup to 15 months
Among participants who develop neutralizing antibody responses, days to decay antibody levels to a 25% level from baseline. NAbs levels, defined as dilution of serum or plasma required to inhibit 50% of virus entry into a target cell lines (ID50) will be measured against the vaccine matched viruses and an additional predominant circulating variant of concern at the time participant samples are collected.
- Change in frequencies of classical (CD14+CD16-) monocytes and markers of activation/inflammation with and without stimulation by by toll like receptor (TLR) and retinoic acid-inducible gene I (RIG-I) like receptors (RLR) ligandsbaseline, 2 weeks
Difference between measures obtained at 2 weeks and baseline in percentage positive. Percentage positive can range from 0 to 100. Change = Percentage positive at 2 weeks - Percentage positive at baseline