Transmission of Respiratory Viruses in Households in The Gambia: a Longitudinal Cohort Study (TransVIR)

NCT05952336 | Unknown

• 1 other identifier: SCC 22556
• Study Type: observational
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

Primary endpoints

• Incidence of symptomatic and asymptomatic infection with SARS-CoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testing
• Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2
• Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2 Secondary endpoints
• Secondary attack rate and household cumulative infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses
• Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid
• Presence of risk factors for symptomatic and asymptomatic infection with respiratory viruses
• Antibody and T cell kinetics of SARS-CoV-2 following infection
• Associations between the magnitude and quality of antibody and T cell responses to seasonal coronaviruses and protection from infection with SARS-CoV-2
• Associations between infection with non-SARS-CoV-2 respiratory viruses and protection from infection with SARS-CoV-2
• Associations between upregulation of gene expression in the mucosa, including interferon stimulated genes (ISGs), and protection from infection with SARS-CoV-2

Conditions

Respiratory Viral Infection; SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (3)

• Incidence of symptomatic and asymptomatic infection with SARS-CoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testing

  with SARS-Incidence of symptomatic and asymptomatic infection with SARS-CoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testingCoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testing * Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2 * Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2

  12 months

• Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2

  Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2

  12 months

• Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2

  Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2

  12 months

Secondary Outcomes (7)

• Secondary attack rate and household cumulative infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses

  12 months

• Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid

  12 months

• Presence of risk factors for symptomatic and asymptomatic infection with respiratory viruses

  12 months

• Antibody and T cell kinetics of SARS-CoV-2 following infection

  12 months

• Associations between the magnitude and quality of antibody and T cell responses to seasonal coronaviruses and protection from infection with SARS-CoV-2

  12 months

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Households will be excluded from participation if they meet any of the following criteria: \- have plans to move away from the study area within the following year. Participants will be excluded from participation if they meet any of the following criteria: * have plans to move away from study area within the following year. * active participant in another research study.

You may qualify if:

• Households must:
• be located in Kanifing municipality or West coast region.
• have at least 5 consented members.
• include the household head as a consented participant.
• have household members that includes at least one adult and at least one child.
• Participants must:
• \- provide informed consent/assent according to their age.

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia: lead
• UK Research and Innovation: collaborator

Study Sites (1)

Field study in the West Coast Region and Kanifing Municipality Clinical Services Department, MRCG MRC Unit The Gambia at LSHTM (Fajara) Laboratories at MRC Unit The Gambia at LSHTM (Fajara) Laboratories at The University of Sheffield, UK

Banjul, West Coast, 0220, The Gambia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: February 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)