Actively Recruiting

Age: 5Years - 75Years
All Genders
NCT05973084

COVID-19 Transmission and Morbidity in Malawi

Led by Boston University · Updated on 2025-06-27

1500

Participants Needed

2

Research Sites

267 weeks

Total Duration

On this page

Sponsors

B

Boston University

Lead Sponsor

N

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

COVID-19 Transmission and Morbidity in Malawi

Who Can Participate

Age: 5Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For index cases: symptomatic with confirmed COVID-19 by RT-PCR or rapid antigen test
  • Aged 5 to 75 years and plans to live in Blantyre for the next 6 months
  • Lives with one or more eligible household members
  • Has not received a SARS-CoV-2 vaccine in the previous 3 months
  • Willing to comply with study procedures and provide informed consent
  • For household contacts: aged 5 to 75 years and plans to live in Blantyre for 6 months
  • Willing to comply with study procedures and provide informed consent
  • Has not received a SARS-CoV-2 vaccine in the previous 3 months
  • For vaccinees: aged 18 to 75 years
  • Willing to receive AstraZeneca and/or Johnson & Johnson vaccines
  • Not part of index case or household contact groups
  • Willing to comply with study procedures and provide informed consent
  • Has not received any prior SARS-CoV-2 vaccine dose
Not Eligible

You will not qualify if you...

  • Conditions preventing adherence to visit schedule
  • Fifty percent or more of household members refuse participation (index cases only)
  • Pregnancy at enrollment
  • Long-term use of cotrimoxazole prophylaxis
  • For household contacts, two consecutive negative SARS-CoV-2 RT-PCR tests exclude from visits after month 1

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

BU School of Public Health, Global Health Department

Boston, Massachusetts, United States, 02118

Active, Not Recruiting

2

Health center

Blantyre, Malawi

Actively Recruiting

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Research Team

C

Clarissa Valim, MD ScD

CONTACT

A

Aditi S Kothari, BDS MDSc MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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COVID-19 Transmission and Morbidity in Malawi | DecenTrialz