There is one clinical trial.
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 3500 individuals, divided into two 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.
Description: Measure the representativeness of participants as compared to the census data for the study region.
Measure: Feasibility of developing an England based sero-epidemiological programme in 0-24 year olds Time: 11monthsDescription: Test serological markers of immunity for vaccine preventable diseases starting with diphtheria.
Measure: Feasibility of developing an England based sero epidemiological survey in 0-24 year olds Time: 11 monthsDescription: Test serological markers of immunity for vaccine preventable diseases including Invasive Meningococcal type C.
Measure: Feasibility of developing an England based sero epidemiological survey in 0-24 year olds Time: 11 monthsDescription: Test serological markers to determine the true number of infections with SARS-CoV-2 in the population.
Measure: Feasibility of developing an England based sero epidemiological survey in 0-24 year olds Time: 11 monthsDescription: Recruitment rate per month, recruitment rates as percentage of potential participants contacted
Measure: Recruitment rate Time: 11 MonthsDescription: Cost per sample obtained of 'disease specific correlates of protection/markers of immunity, e.g. Anti-Diphtheria Toxoid IgG concentrations and Capsular Group C meningococcal Serum bactericidal activity (SBA) titres and Serum IgG to SARS-CoV-2 antigens, including spike protein (as measured by ELISA and/or neutralising assay)
Measure: Cost Time: 12 monthsDescription: IgG to COVID-19 spike protein
Measure: To assess, in relevant age groups, antibody concentrations against infections and vaccine preventable diseases Time: 11 monthsDescription: A collection of anonymised sera from participants with appropriate consent and known demographic details and immunisation history. Serum IgG to SARS-CoV-2 antigens, including spike protein (as measured by ELISA and/or neutralising assay)
Measure: Sera collection Time: 11 monthsDescription: • Representativeness of participants sampled, in terms of the local population's ethnicity, community identity, migrant population and socioeconomic background in group 1 and group 2. Differences in immunological read outs PCR for SARS-CoV-2 on saliva samples this will be stored and processed at the end of the study. IgA to SARS-CoV-2 in saliva paired with serum samples.
Measure: Exploratory Time: 11 monthsDescription: • T cell responses to SARS-CoV-2 antigens including, but not limited to S, M and N proteins, as measured by techniques including, but not limited to ELISpot ICS Proliferation assay
Measure: Exploratory Time: 6 monthsDescription: • Antigen specific IgG and T cells against non-SARS-CoV-2 coronaviruses (e.g. NL62 and 229E)
Measure: Exploratory Time: 6 months