NCT04061382: STORY

Sero-epidemiological Survey of England in 2019/2020 - COVID-19

Completed Last updated 20 March 2025

What this trial tests

trial testing Venepuncture in Serogroup C Meningococcal Meningitis in 2,963 participants. Completed in 14 June 2022.

Timeline

15 October 2019

Primary endpoint
30 June 2021

14 June 2022

Quick facts

Lead sponsor	University of Oxford
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,963
Start date	15 October 2019
Primary completion	30 June 2021
Estimated completion	14 June 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Venepuncture
• Oral fluid swab

Conditions studied

• Serogroup C Meningococcal Meningitis — all drugs for Serogroup C Meningococcal Meningitis →
• Diphtheria — all drugs for Diphtheria →
• COVID-19 — all drugs for COVID-19 →

Sponsor

University of Oxford

Who can join

Adults 1 Day to 24, any sex, with Serogroup C Meningococcal Meningitis or Diphtheria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a pilot study to assess the feasibility of establishing a national sero-epidemiological survey in England in individuals aged 0-24 years, focusing on assessing humoral immunity against diphtheria, Group C invasive meningococcus and SARS-CoV-2. The investigators will recruit 2800 to 3800 individuals, divided into three groups:

Group one (N= 2300):

This will include all age groups (0-24years), with recruitment restricted by postcodes provided by Public Health England (PHE) to recruit a representative population for the region as assessed by the IMD (Index of Multiple Deprivation scores).

Group two (N= up to 1200):

This group has been added following additional funding to enhance the sample size in response to the COVID-19 pandemic. This will recruit 0-19 year olds and will not be restricted by post code sampling. Instead recruitment will be by public promotion within the normal recruiting regions for each site.

Group three (N= up to 300):

Addition of Group 3 which is enhanced surveillance in participants from Black, Asian or minority ethnic groups (BAME). Since the start of recruitment we have noted that only 11% of participants are from BAME population, despite recruiting in ethnically diverse regions. Given the increased risk of COVID-19 disease in the BAME community, this is a potential limitation of the study as it stands, not only because it may not reflect the diversity of the UK population, but because it does not allow assessment of whether the differing disease rates and seropositivity in adults are reflected in differences in seropositivity rates in children. Similarly to Group 2, this will recruit 0-19 year olds and will not be restricted by post code sampling.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Community seroprevalence of SARS-CoV-2 in children and adolescents in England, 2019-2021.
   Ratcliffe H, Tiley KS, Andrews N, Amirthalingam G, et al · · 2023 · cited 9× · PMID 35858775 · DOI 10.1136/archdischild-2022-324375
2. Serum HCoV-spike specific antibodies do not protect against subsequent SARS-CoV-2 infection in children and adolescents.
   Ratcliffe H, Tiley KS, Longet S, Tonry C, et al · · 2023 · cited 6× · PMID 38089581 · DOI 10.1016/j.isci.2023.108500