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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: SARS CoV 2 Infection; Respiratory Viral Infection

Detailed Description

A prospective, observational cohort study within households in West Coast Region and Kanifing Municipality, The Gambia. A total of 50 - 70 households will be recruited. All members of the household will be included other than those who do not meet the eligibility criteria or decline to consent for the study. Participants will be enrolled for a total of 52 weeks, undergoing weekly field visits, along with an enrolment visit (V1), 6-month visit (V2) and 12-month visit (V3), which will all be clinic based. Clinic visits will collect anthropometric, socio-demographic and clinical data (including risk for acquisition of SARS-CoV- 2). In addition, a combined throat and nose swab (TNS), nasal lining fluid (NLF) using a synthetic absorptive matrix (SAM) strip, and a blood sample will be taken. Weekly visits will be done at the participants' homes or work place. During these visits, TNS will be collected, along with the presence of symptoms consistent with respiratory viral infections. In addition, participants who have symptoms consistent with influenza-like-illnesses (ILI) will have unscheduled visits where clinical data and a TNS is collected, which will be tested in real time for SARS-CoV-2 using PCR. Participants will be informed of their results within 24 hours after this TNS sample is collected at unscheduled ILI visits. Positive results will be communicated to the Ministry of Health for their records and contact tracing. Weekly TNS from all household members of any positive SARS-CoV-2 case will also be tested in real time for SARS-CoV-2 for 4 weeks following the most recent SARS-CoV- 2 positive case in the household. All participants with symptomatic SARS-CoV-2 detected at an unscheduled ILI visit will be seen at an additional clinic visit (post-covid follow up), where further TNS, NLF and blood samples will be taken.

• Study Type: Observational
• Enrollment (Actual): 349

Contacts and Locations

Study Locations

• Gambia
  • Western Region
    • Banjul, Western Region, Gambia, 0220
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary attack rate and household cumulative infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses	Secondary attack rate and household cumulative infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses 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	12 months
Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid	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	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	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	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
Associations between infection with non-SARS-CoV-2 respiratory viruses 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	12 months
Associations between upregulation of gene expression in the mucosa, including interferon stimulated genes (ISGs), 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	12 months

Collaborators and Investigators

• Sponsor: Medical Research Council Unit, The Gambia
• Collaborators: UK Research and Innovation

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: SCC 22556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No