COVID-19 Transmission and Morbidity in Malawi

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 75
Healthy Volunteers: f
View:

• Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test;

• 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;

• Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age;

• Has not received a SARS-CoV-2 vaccine in the previous 3 months

• Willingness to comply with study procedures and visits, and provides informed consent.

⁃ Household Contacts of the Confirmed SARS-CoV-2 Case

• 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;

• Willingness to comply with study procedures and follow-up visits and provides informed consent.

• 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 and/or JJ vaccines 2) Not in the other 2 cohorts; 4) Willingness to comply with study procedures and follow-up visits and provides informed consent.

⁃ 5\) Has not received a prior dose of a SARS-CoV-2 vaccine

Locations
United States
Massachusetts
BU School of Public Health, Global Health Department
ACTIVE_NOT_RECRUITING
Boston
Other Locations
Malawi
Health center
RECRUITING
Blantyre
Contact Information
Primary
Clarissa Valim, MD ScD
cvalim@bu.edu
(617) 414-1260
Backup
Aditi S Kothari, BDS MDSc MPH
aditi@bu.edu
(617) 358-2441
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2028-03
Participants
Target number of participants: 1500
Treatments
Natural infection cohort
Up to 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 5-75 years who provide consent (participants) will be examined for infection through two consecutive SARS-CoV-2 RT-PCR. Blood will be drawn from all participants who provide consent. Venous Blood will be drawn at the first visit (so called W0). A second collection is planned for 15 days after the first visit, a third collection at three months after the first visit, and subsequent collections are planned at six, nine, and 15 months after the first visit. At the visits one month, nine months and 15 months after the first visit, capillary blood will be collected. A stool sample will be collected for diagnosis of intestinal parasites.
Vaccine cohort
Up to 600 subjects 18-75 years will be recruited when they attend a vaccination clinic at one of the study health centers in Blantyre to receive their 1st dose of the AstraZeneca (AZ) or the Johnson and Johnson (JJ) COVID-19 vaccines. Venous blood will be collected at that time. For AZ vaccinees, at their 2nd vaccine dose, about 90 days after the 1st dose, they will be given a stool sample container. JJ vaccinees will receive the stool sample container when they receive the first vaccine dose. Two weeks after completion of the primary regimen (2nd dose of the AZ \[M3.5\] and 1st dose of the JJ vaccines \[M0.5\]), venous blood draws will be repeated and stool containers will be collected. Subsequent visits/procedures will happen at one month thereafter (M4.5 for AZ and M1.5 for JJ), and 3, 6, 9, and 12 months after the primary regimen. Venous blood will be collected at the visit 1.5, 3, 6, and 12 months after the primary regimen and capillary blood will be collected at the other visits.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Malaria Alert Center, Kamuzu University of Health Sciences, Burnet Institute
Leads: Boston University

This content was sourced from clinicaltrials.gov