PRIME Follow up - Quadri Meningo Vacinees
PRIME Follow up - Quadri Meningo Vacinees
A previous cohort of 93 clinical trial participants received quadrivalent meningococcal
 conjugate vaccine, which includes strains ACW and Y, in their teenage years. The vaccine also
 contains components of diphtheria and tetanus which are linked to the meningitis components,
 in a process called conjugation, to improve their effectiveness.

 Participants are now aged 19-25 and will be invited to take part in this study, which will
 assess antibody persistence over time. This will provide information about the duration of
 protection by relating current antibody levels to those measured in the previous study, and
 will underpin the national immunisation schedule in providing optimal immunisation schedule.
 As well as the meningitis antibodies the investigators will assess diphtheria and tetanus
 antibody levels.

 The study will involve a single blood test of up to 8mL. Participants will be informed of
 their results and any with an antibody level that does not infer protection against strain W
 will be offered an extra dose of vaccine as part of a duty of care.

 The study will involve a single blood test of up to 8mL. Participants will be informed of
 their results and any with an antibody level that does not infer protection against strain W
 will be offered an extra dose of vaccine.
The UK was the first country in the world to introduce the meningococcal serogroup C
 conjugate vaccine (MCC) into its routine immunisation schedule in 1999. This very effectively
 reduced the incidence of disease, which was highest in those younger than 1 year through its
 routine use in the infant immunisation schedule, and those aged around 15-17 years through a
 catch up campaign . Subsequently, the meningococcal vaccination schedule has undergone
 several revisions, including:

 -  2006 - a reduction in the number of doses given to infants from the manufacturer advised
 three to the JCVI instructed two with the combination of the MCC dose in the second year
 of life with the Hib vaccine, in the form of Menitorix

 -  2013 - a further reduction to a single dose in infancy and the introduction of a booster
 in teenage years due to studies demonstrating that antibody persistence was short lived
 through childhood

 -  2015 - the amendment of the teenage booster dose from MCC to a quadrivalent
 meningococcal conjugate vaccine to address the increasing incidence of serogroup W
 disease in this age group (PHE website - Meningococcal data), and the introduction of
 Bexsero into the infant schedule ostensibly to address meningococcal B disease but with
 the potential for cross protection against other serogroups, which is currently being
 assessed in another NVEC study.

 -  2016 - removal of the MCC at 3 months of age.

 Given the previous demonstration of poor antibody persistence of MenC antibodies two years
 following the 2006 schedule, with only 43%, 22% and 23% of children achieving SBA titres ≥8
 two years following a booster dose of Menitorix™ when primed with NeisVac-C™, Menjugate™ and
 Meningitec™, respectively, there is concern about the protection afforded by the quadrivalent
 vaccine administered at around 14 years of age, and whether this will provide protection into
 young adulthood when the risk of disease is high.

 In a previous study by this group (Eudract number 2010-022505-18) , adolescents aged 16-19
 years were randomised to receive one of two licensed meningococcal ACWY conjugate vaccines:

 1. Menveo™ (GSK) This vaccine contains bacterial capsular oligosaccharides for serogroups
 A, C, W, and Y conjugated to a protein carrier, CRM197, which is a nontoxigenic natural
 variant of diphtheria toxin. The MenACWY vaccine has been tested in several age groups
 and has been shown to be generally well tolerated and immunogenic. Menveo™ is indicated
 for use in those from 2 years of age and in those at risk.

 2. Nimenrix (Pfizer) This vaccine contains bacterial capsular oligosaccharides for
 serogroups A, C, W, and Y conjugated to Tetanus Toxoid (TT). This MenACWY-TT vaccine has
 been tested in several age groups and has been shown to be safe and immunogenic. It is
 indicated for use from 12 months of age and in those at risk.

 The cohort included in this study was one of the first to receive meningococcal C conjugate
 vaccine as young children, and subsequently to have the booster in the form of meningococcal
 quadrivalent (ACWY) conjugate vaccination at age 16-19 years. This group of 93 young adults,
 now aged 20-24 years, provides a unique opportunity to study the persistence of meningococcal
 serogroup-specific antibodies over time. This is particularly important given the recent
 increases in incidence of meningococcal W disease which prompted the amendment of the
 national schedule to include a booster of the meningococcal quadrivalent vaccine in teenage
 years.
Inclusion Criteria:

 -  Individual is willing and able to give written informed consent for participation.

 -  Individual was originally enrolled in the randomised parallel group study of
 quadrivalent meningococcal vaccination.

 Exclusion Criteria:

 -  Known bleeding diathesis (or any condition that may be associated with a prolonged
 bleeding time).

 -  Any other significant condition or circumstance which, in the opinion of the
 investigator, may either put the participant at risk because of participation in the
 study, or may influence the result of the study, or the participant's ability to
 participate in the study.