Understanding the immune response to meningitis vaccines

• Research type

  Research Study

• Full title

  A single centre, open-label, randomised clinical trial to investigate meningococcal serogroup A, C, W-135 and Y saccharide specific B cell response to a primary and a booster dose of the meningococcal ACWY conjugate vaccine and to a primary dose of the ACWY polysaccharide vaccine followed by a booster dose of the meningococcal ACWY conjugate vaccine administered to adult volunteers.

• Contact name

  AJ Pollard

• Eudract number

  2007-001349-17

• ISRCTN Number

  N/A

• Research summary

  The purpose of the study is to evaluate and compare the immune response to two vaccines against 4 related bacteria, meningococcal serogroups A, C, W-135 and Y. These bacteria can cause meningitis and /or septicaemia (blood poisoning). The two vaccines are an investigational protein-polysaccharide conjugate vaccine (MenACWY) and a licensed meningococcal plain polysaccharide vaccine (MenACWY PS). The plain polysaccharide Meningococcal A, C, W-135 and Y vaccine is the one currently recommended for travellers to areas with a high incidence of invasive meningococcal disease. However, plain polysaccharide vaccines are known to be poorly immunogenic in children and they do not stimulate immunological memory, apart from the serogroup A component. In contrast, a protein-polysaccharide conjugate vaccine against meningococcal serogroups A, C, W-135 and Y has been found to be immunogenic in infants and to be able to induce immunological memory. The proposed study is a single centre, open-label, randomised, controlled study in 150 healthy adults aged 18-50 years. The participants will be given either 2 injections of experimental meningococcal protein-polysaccharide conjugate vaccine one month apart, or one injection of licensed meningococcal plain polysaccharide vaccine followed one month later with an injection of experimental meningococcal conjugate vaccine. Blood samples will be collected at several time points prior and post vaccinations to evaluate the level of meningococcal specific antibody induced by two different vaccination regimes. The data derived from the study will be relevant in determining which of these vaccines should be used in preference in travellers who are receiving immunisation against meningococcal disease before travelling to high risk areas. Additionally, a number of scientific questions regarding the nature of the immune response to the two vaccines (specifically looking at the white blood cells responsible for producing antibodies, known as b cells) and the role of genetic variations in fluncing the vaccine recipient's immune response will be addressed in the study.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/20

• Date of REC Opinion

  2 Apr 2009

• REC opinion

  Further Information Favourable Opinion