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Respiratory Viral InfectionTransVIRNCT05952336

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

An observational study of Respiratory Viral Infection and SARS CoV 2 Infection, run by Medical Research Council Unit, The Gambia at 1 site in The Gambia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
How many people
349 participants
Where
1 siteThe Gambia
Study dates
1 Feb 2021to 31 Jan 2024
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

The Gambia1 site

  • 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

Other trials in The Gambia

About this study

Official title: 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
Read the 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.

Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. 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

    Measured: 12 months

Secondary outcomes (7)

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

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

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

    Measured: 12 months

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

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

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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

    Measured: 12 months

  7. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start1 Feb 2021
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
349 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952336
Sponsor's protocol ID
SCC 22556
Acronym
TransVIR
Status last verified
Jul 2023
First submitted
11 Jul 2023
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Viral Infection and SARS CoV 2 Infection, run by Medical Research Council Unit, The Gambia at 1 site in The Gambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05952336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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