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|Meningitis, Meningococcal NIH
|Meningitis, Mening NIH
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. 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.
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 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 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 Serum IgG to SARS-CoV-2 antigens, including spike and nucleocapsid protein (as measured by ELISA and/or neutralising assay)Measure: Cost Time: 12 months
Description: IgG to COVID-19 spike and nucleocapsid proteinMeasure: To assess, in relevant age groups and different ethnicities antibody concentrations 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 history. Serum IgG to SARS-CoV-2 antigens, including spike and nucleocapsid protein (as measured by ELISA and/or neutralising assay)Measure: 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 between groups. 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 months
Description: • 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 assayMeasure: Exploratory Time: 6 months
Description: • Antigen specific IgG and T cells against non-SARS-CoV-2 coronaviruses (e.g. NL62 and 229E)Measure: Exploratory Time: 6 months
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports