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

• ClinicalTrials.gov Identifier: NCT05952336
• Recruitment Status: Active, not recruiting
• First Posted: July 19, 2023
• Last Update Posted: July 19, 2023
• Sponsor: Medical Research Council Unit, The Gambia
• Collaborator: UK Research and Innovation
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine ( Medical Research Council Unit, The Gambia )

Study Description

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

Condition or disease
Respiratory Viral Infection; SARS CoV 2 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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 349 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 12 Months
• Official Title: Transmission of Respiratory Viruses in Households in The Gambia: a Longitudinal Cohort Study
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: January 31, 2024
• Estimated Study Completion Date: January 31, 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Incidence of symptomatic and asymptomatic infection with SARS-CoV-2 and other respiratory viruses as determined by molecular (e.g. PCR) and serological testing [ Time Frame: 12 months ]

   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
2. Associations between the magnitude and quality of mucosal and serum antibody responses to SARSCoV- 2 and protection from infection with SARS-CoV-2 [ Time Frame: 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
3. Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2 [ Time Frame: 12 months ]
   Associations between the magnitude and quality of T cell responses to SARS-CoV-2 and protection from infection with SARS-CoV-2

Secondary Outcome Measures :

1. Secondary attack rate and household cumulative infection rate with SARS-CoV-2, influenza, RSV, and other respiratory viruses [ Time Frame: 12 months ]

   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
2. Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid [ Time Frame: 12 months ]
   Seroincidence and seroprevalence of SARS-CoV-2 a determined by binding antibodies to SARS-CoV-2 spike and nucleocapsid
3. Presence of risk factors for symptomatic and asymptomatic infection with respiratory viruses [ Time Frame: 12 months ]
   Presence of risk factors for symptomatic and asymptomatic infection with respiratory viruses
4. Antibody and T cell kinetics of SARS-CoV-2 following infection [ Time Frame: 12 months ]
   Antibody and T cell kinetics of SARS-CoV-2 following infection
5. Associations between the magnitude and quality of antibody and T cell responses to seasonal coronaviruses and protection from infection with SARS-CoV-2 [ Time Frame: 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
6. Associations between infection with non-SARS-CoV-2 respiratory viruses and protection from infection with SARS-CoV-2 [ Time Frame: 12 months ]
   Associations between infection with non-SARS-CoV-2 respiratory viruses and protection from infection with SARS-CoV-2
7. Associations between upregulation of gene expression in the mucosa, including interferon stimulated genes (ISGs), and protection from infection with SARS-CoV-2 [ Time Frame: 12 months ]
   Associations between upregulation of gene expression in the mucosa, including interferon stimulated genes (ISGs), and protection from infection with SARS-CoV-2

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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:

-

Contacts and Locations

Locations

Gambia

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, Western Region, Gambia, 0220

Sponsors and Collaborators

Medical Research Council Unit, The Gambia

UK Research and Innovation

More Information

• Responsible Party: Medical Research Council Unit, The Gambia
• ClinicalTrials.gov Identifier: NCT05952336
• Other Study ID Numbers: SCC 22556
• First Posted: July 19, 2023
• Last Update Posted: July 19, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; COVID-19; Virus Diseases; Disease Attributes; Pathologic Processes; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases