Understanding the persistence of immunity after MenC vaccines, ver 1

• Research type

  Research Study

• Full title

  An observational study into the maintenance of seroprotection against Meningococcal serogroup C disease throughout childhood following a single dose of a conjugated Meningococcal serogroup C vaccine administered to toddlers

• IRAS ID

  43841

• Contact name

  Matthew Snape

• Sponsor organisation

  Oxford University Hospitals NHS Foundation Trust

• Eudract number

  2010-019091-78

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Adolescence is a time of increased risk of invasive meningococcal disease. A cohort of children who only received a single dose of a Meningococcal serogroup C (MenC) vaccine will now be entering this at-risk age-group with potentially low antibody levels which will not protect them from invasive disease. As part of a separate study (U01-Td5I-303/ C01.183), blood samples were taken from children at 4 different time points over 6 years. All of these children had received a single dose of a MenC vaccine at age 1-3 years in the catch-up immunisation campaign. Anonymised serum samples have been stored from these venesections from children whose parents gave consent for the serum to be stored following the completion of the original study. We would like to use these stored sera to analyse for MenC serum bactericidal activity (SBA) to give an indication of how long children are protected against invasive MenC disease after a single dose of vaccine'stage 1). We would also like to approach the families that took part in this original study to ask if they would like to participate in a new study looking at the longterm persistence of MenC SBA in children. Families who give consent to participate in this study would be asked if they would agree to a further blood sample to be taken in 2010 (stage 2). The results from the 2 stages of this study will be analysed to demonstrate the changes in antibody concentrations and SBA titres over time. All children who participate in stage 2 of the study will be offered a booster dose of a MenC vaccine (optional) after the blood sample is taken.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/42

• Date of REC Opinion

  14 Jun 2010

• REC opinion

  Further Information Favourable Opinion