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More info
You can access this
clinical trial
if you have
Meningitis or Septicemia
and you are
between 18 and 70
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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 a protein−polysaccharide conjugate vaccine (MenACWY)and a meningococcal plain polysaccharide vaccine(MenACWY PS). Both vaccines are licensed and are currently used 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 18−70 years. The participants will be given either 2 injections of the meningococcal protein−polysaccharide conjugate vaccine one month apart, or one injection of the meningococcal plain polysaccharide vaccine followed one month later with an injection of the meningococcal conjugate vaccine. Blood samples will be collected before immunisation and at several time points following immunisations 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 influencing the vaccine recipient's immune response will be addressed in the study.

Provided treatments

  • Biological: Meningococcal (Groups A, C, Y and W-135) Conjugate
  • Biological: Meningococcal polysaccharide A, C, Y and W135 and Menveo
Tris trial is registered with FDA with number: NCT00901940. The sponsor of the trial is University of Oxford and it is looking for 150 volunteers for the current phase.
Official trial title:
Single Centre Open-Label Randomised Trial of Meningococcal Serogroup ACYW-135 B Cell Response to Primary & Booster Doses of ACWY Conjugate Vaccine & Primary Dose of ACWY Polysaccharide With Booster Dose of ACWY Conjugate in Adults