A phase III observer-blind randomized, controlled study to evaluate the immune response and the correlation with nasopharyngeal carriage after immunization of university students with a quadrivalent meningococcal ACWY glycoconjugate or serogroup B meningococcal vaccine

Vaccine. 2017 Jan 11;35(3):427-434. doi: 10.1016/j.vaccine.2016.11.071. Epub 2016 Nov 29.

Abstract

Background: University students have high rates of pharyngeal carriage of Neisseria meningitidis. Interruption of carriage acquisition is an important mechanism of vaccines for inducing herd protection. 4CMenB and MenACWY-CRM vaccines have been shown to be immunogenic against meningococcal serogroups B and ACWY respectively in younger age groups, and also to elicit a modest impact on meningococcal carriage in vaccinated students. However, vaccine responses in university students and the impact of serum bactericidal antibody (SBA) titers on meningococcal carriage are undetermined.

Methods: Immunogenicity of two 4CMenB doses or one MenACWY-CRM dose was measured in university students at Months 2, 4, 6 and 12 post-first vaccination. Immunogenicity of one MenACWY-CRM dose in students with previous meningococcal serogroup C conjugate vaccination was also assessed. Immune responses were measured with an SBA assay using human complement (hSBA) against three reference strains for serogroup B and against one strain for each for serogroups C and Y. Correlations between hSBA titers and meningococcal carriage were analyzed.

Results: All subjects demonstrated robust functional antibody responses to both vaccines at Month 2 and a high proportion maintained protective hSBA titers up to Month 12. At baseline, carriage of disease-associated serogroup B strains and serogroups C and Y were higher in subjects with already-protective hSBA titers. Post-vaccination, while both 4CMenB and MenACWY-CRM elicited robust immunogenicity in students, significant correlations between post-vaccination hSBA titers and carriage of disease-associated serogroups were not observed.

Conclusions: 4CMenB and MenACWY-CRM were both highly immunogenic. There was no correlation between carriage and post-vaccination hSBA titers.

Keywords: Carriage; Immunogenicity; Meningococcal; Serogroup B; Vaccine.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Antibodies, Bacterial / blood
  • Blood Bactericidal Activity
  • Carrier State / microbiology
  • Carrier State / prevention & control*
  • Female
  • Humans
  • Male
  • Meningococcal Infections / microbiology
  • Meningococcal Infections / prevention & control*
  • Meningococcal Vaccines / administration & dosage
  • Meningococcal Vaccines / immunology*
  • Nasopharynx / microbiology*
  • Neisseria meningitidis / classification
  • Neisseria meningitidis / isolation & purification*
  • Single-Blind Method
  • Students
  • Universities
  • Young Adult

Substances

  • 4CMenB vaccine
  • Antibodies, Bacterial
  • MenACWY-CRM vaccine
  • Meningococcal Vaccines