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

Medical Research Council Unit, The Gambia

Status

Active, not recruiting

Conditions

SARS CoV 2 Infection

Respiratory Viral Infection

Study type

Observational

Funder types

Other

Identifiers

NCT05952336

SCC 22556

Details and patient eligibility

About

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

Full 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.

Enrollment

349 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria