|D008585||Meningitis, Meningococcal NIH||1.00|
|D008581||Meningitis, Mening NIH||1.00|
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 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=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: 11months
Description: 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 months
Description: 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 months
Description: Test serological markers of immunity for COVID-19.Measure: Feasibility of developing an England based sero epidemiological survey in 0-24 year olds Time: 11 months
Description: Recruitment rate per month, recruitment rates as percentage of potential participants contactedMeasure: Recruitment rate Time: 11 Months
Description: 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 IgG to COVID-19 spike protein (as measured by ELISA and/or neutralising assay)Measure: Cost Time: 11 months
Description: IgG to COVID-19 spike proteinMeasure: To assess, in relevant age groups, immunity against infections and vaccine preventable diseases Time: 11 months
Description: A collection of anonymised sera from participants with appropriate consent and known demographic details and immunisation historyMeasure: Sera collection Time: 11 months
Description: 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 outsMeasure: Exploratory Time: 11 months