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COVID-19 Transmission and Morbidity in Malawi

NCT05973084 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

  • SARS CoV 2 Infection
  • SARS CoV 2 Vaccination

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Malaria Alert Center, Kamuzu University of Health Sciences

    collaborator UNKNOWN

  • Burnet Institute

    collaborator OTHER

  • Boston University

    lead OTHER

Principal Investigators

  • Clarissa Valim, MD ScD · BU School of Public Health, Department of Global Health

  • Don Mathanga, MBBS PhD · Kamuzu University of Health Sciences, Malaria Alert Center, Malawi

  • Patricia Hibberd, MD PhD · BU School of Public Health, Department of Global Health

  • James Beeson, MBBS PhD · Burnet Institute, Australia

Eligibility

Min Age
5 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • United States
  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973084 on ClinicalTrials.gov