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

NCT04061382 | Completed DMC

• 1 other identifier: ID 263097
• Study Type: observational
• Target: 2,963
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Serogroup C Meningococcal Meningitis; Diphtheria; COVID-19

Outcome Measures

Primary Outcomes (4)

• Feasibility of developing an England based sero-epidemiological programme in 0-24 year olds

  Measure the representativeness of participants as compared to the census data for the study region.

  11months

• Feasibility of developing an England based sero epidemiological survey in 0-24 year olds

  Test serological markers of immunity for vaccine preventable diseases starting with diphtheria.

  11 months

• Feasibility of developing an England based sero epidemiological survey in 0-24 year olds

  Test serological markers of immunity for vaccine preventable diseases including Invasive Meningococcal type C.

  11 months

• Feasibility of developing an England based sero epidemiological survey in 0-24 year olds

  Test serological markers to determine the true number of infections with SARS-CoV-2 in the population.

  11 months

Secondary Outcomes (7)

• Recruitment rate

  11 Months

• Cost

  12 months

• To assess, in relevant age groups and different ethnicities antibody concentrations against infections and vaccine preventable diseases

  11 months

• Sera collection

  11 months

• Exploratory

  11 months

Study Arms (3)

Randomised selection of population - Group 1

Group 1 will be focusing on COVID-19, diphtheria and group C invasive meningococcal disease. The investigators are aiming to recruit around 2300 individuals and the investigators are aiming to ensure that sample is broadly representative of the region according to IMD (Index of Multiple Deprivation scores). PHE have generated a list of all postcodes in recruiting regions and determining the quintiles of IMD within that region. Participants interested in taking part in the study will contact sites to arrange a visit. Basic demographic characteristics will be collected by questionnaire and/ or case report form (CRF) and will include: DOB, gender, GP details, Ethnic group, association with communities of special interest, household income and vaccination history.The questionnaire will gather information regarding potential COVID-19 symptoms both in the participant and the participant's household.

Procedure: Venepuncture; Procedure: Oral fluid swab

Group 2

Group two will focus on 0-19 year olds only. They will not be restricted to the post code sampling. Instead this will include standard recruitment methods such as social media advertisements within the normal recruiting regions for each site. Other methods of recruitment are identification of potential participants by the local study team, staff communication channels and inpatients or outpatients clinics as long as potential participants are not patients. The questionnaire will gather information regarding potential COVID-19 symptoms both in the participant and the participant's household. A proportion of participants from this group from selected sites will also provide up to a maximum of three blood samples for separation of peripheral blood mononuclear cells (PBMCs) to evaluate T cell responses. These participants can be either seronegative or seropositive at their Visit 1.

Procedure: Venepuncture; Procedure: Oral fluid swab

Group 3

Group three will consist of up to 300 participants aged 0-19 from the Black, Asian and Minority ethnic population aged 0-19 years. They will not be restricted to the post code sampling and will be recruited at a sub-set of sites depending on capacity and the demographic profile of the local population. Recruitment will be by multiple approaches, including mail outs, radio and advertising in community (e.g. community centres, religious establishments) or Pharmacies and GP practices where we have ethics approval for them to act as PICs. These can vary according to each site's experience and their contacts within their local community on how is best to approach the BAME community. Other methods of recruitment are identification of potential participants by the local study team, staff communication channels and inpatients or outpatients clinics as long as potential participants are not patients.

Procedure: Venepuncture; Procedure: Oral fluid swab

Interventions

Venepuncture PROCEDURE

One study visit will be conducted by research study staff and blood sampling will be carried out. Up to three follow-up visits will be conducted for a percentage of participants, where additional blood samples will be collected. The blood sample will initially focus on looking at population immunity to diphtheria, group C invasive meningococcal disease and SARS-CoV-2.

Group 2; Group 3; Randomised selection of population - Group 1

Oral fluid swab PROCEDURE

Saliva sampling will be collected during the follow-up visits. This swab will be collected either by the participant or the participants parent/guardian on the day of the visit. The saliva sampling will primarily be analysed for SARS-CoV-2 antibodies.

Group 2; Group 3; Randomised selection of population - Group 1

Eligibility Criteria

• Age: 1 Day - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Basic demographic characteristics will be collected by questionnaire and/or case report form (CRF) and will include: DOB, gender, GP details, ethnic group, association with communities of special interest (e.g. faith communities) household income and vaccination history. Vaccination history will be verified during serum sample collection using the Red Book or other vaccination records, or checking with the general practitioner or the Child Health Immunisation Service (CHIS) database. Where possible this will include batch information for diphtheria pre-school booster to determine which specific product was received.

You may qualify if:

• Parents/legal guardians or adult participant\* is willing and able to give informed consent for participation in the study.
• Male or Female, aged 0 - 24 years inclusive (Group 1)
• Male or Female, aged 0 - 19 years inclusive (Group 2)
• Male or Female, aged 0 - 19 years inclusive with BAME background (Group 3)
• Parents/legal guardians or adult participants are willing to allow their General Practitioner or relevant NHS databases to be contacted for a full immunisation history

You may not qualify if:

• If participants do not live in the postcode districts selected by PHE (Group 1 only)
• If participants are not from the BAME population (Group 3 only
• Medically diagnosed bleeding disorder
• Medically diagnosed platelet disorder
• Anticoagulation medication
• Pregnancy
• If another member of their household is participating who is within 5 years of age of the potential participants age
• The participant may not enter the study if they or any member of their household is under temporary isolation measures for suspected SARS-CoV-2 infection.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

• Ratcliffe H, Tiley KS, Andrews N, Amirthalingam G, Vichos I, Morey E, Douglas NL, Marinou S, Plested E, Aley P, Galiza EP, Faust SN, Hughes S, Murray CS, Roderick M, Shackley F, Oddie SJ, Lees T, Turner DPJ, Raman M, Owens S, Turner P, Cockerill H, Lopez Bernal J, Linley E, Borrow R, Brown K, Ramsay ME, Voysey M, Snape MD. Community seroprevalence of SARS-CoV-2 in children and adolescents in England, 2019-2021. Arch Dis Child. 2023 Jan 19;108(2):123-130. doi: 10.1136/archdischild-2022-324375.

  PMID: 35858775 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be centrifuged, separated and frozen at local sites at -80°C. Ideally this will happen within 24h with a window of up to 72h. Up to two 2ml aliquots per participant will be shipped to PHE in batches of up to 500 on dry ice. Residual sera beyond this volume will be shipped to the Oxford Vaccine Group(OVG) for storage. For participants where consent is obtained for DNA extraction and storage in the Oxford Vaccine Centre biobank residual blood clots will be shipped to the OVG for this purpose. Participant or their parents will take the oral fluid swab on the day of the visit. Once received by the study team it will be kept in a cool bag until the samples arrive in the lab. They will then be frozen to -80° before being shipped to PHE. Blood samples collected for T cell testing will be shipped to the OVG lab for same-day processing for separation of PBMCs. Saliva samples with be processed in line with local SOPs

MeSH Terms

Conditions

Meningitis, Meningococcal; Diphtheria; COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Matthew Snape, Professor

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 19, 2019
• Study Start: October 15, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 14, 2022
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)