RECRUITING

COVID-19 Transmission and Morbidity in Malawi

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

COVID-19 Transmission and Morbidity in Malawi

Quick Facts

Study Start:2023-01-17
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05973084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clarissa Valim, MD ScD
CONTACT
(617) 414-1260
cvalim@bu.edu
Aditi S Kothari, BDS MDSc MPH
CONTACT
(617) 358-2441
aditi@bu.edu

Principal Investigator

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

Study Locations (Sites)

BU School of Public Health, Global Health Department
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston University

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-17
Study Completion Date2028-03

Study Record Updates

Study Start Date2023-01-17
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • Natural infection
  • Immune phenotypes
  • Innate immunity
  • SARS CoV 2 adaptive immunity
  • SARS CoV 2 antibody response
  • Vacinees
  • Household contacts
  • Malawi
  • Sub Saharan Africa

Additional Relevant MeSH Terms

  • SARS CoV 2 Infection
  • SARS CoV 2 Vaccination