Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods

Vaccine. 2019 Jul 26;37(32):4460-4467. doi: 10.1016/j.vaccine.2019.06.076. Epub 2019 Jul 3.

Abstract

Background: The quadrivalent meningococcal conjugate vaccine MenACWY-CRM has been shown to be immunogenic and well-tolerated in infants and toddlers. We evaluated antibody persistence for up to 4 years after vaccination with MenACWY-CRM in the first years of life and response to a booster dose administered at 60 months of age.

Methods: This was phase 3b, open-label, multicenter extension trial (NCT01148017). We assessed by hSBA and rSBA the persistence of antibody responses to serogroups ACWY in 203 healthy 60-month-olds receiving 4 doses of MenACWY-CRM during infancy (ACWY-4 group), or 2 doses at 12/13 and 15 months or 1 dose at 18 months of age (ACWY-2 group). We administered a MenACWY-CRM dose to 224 primed and 45 naïve 60-month-olds and evaluated safety and antibody response 1 month later.

Results: Antibody persistence measured by both assays was higher in primed than naïve 60-month-olds. The percentages of primed children with hSBA titers ≥8 was low for serogroup A (6-25%) and moderate for serogroups C (27-43%), Y (69-74%) and W (56-69%). For all serogroups, hSBA antibody geometric mean titers (GMTs) tended to be higher in the ACWY-2 than the ACWY-4 group. Post-booster/single dose, ≥96% of primed and ≥73% of naïve children had hSBA titers ≥8 against each serogroup, and hSBA GMTs were higher in primed children. The booster dose was well-tolerated and no safety concern was identified. We further assessed persistence using rSBA across different age groups and detected no overall correlation between rSBA and hSBA titers.

Conclusions: Primary vaccination of infants/toddlers with MenACWY-CRM resulted in moderate antibody persistence against serogroups C, W and Y for up to 4 years after the last priming dose. Regardless of priming schedule, a MenACWY-CRM booster dose at 60 months of age induced a robust immune response against all serogroups and was well-tolerated in all children.

Keywords: Booster; MenACWY-CRM; Meningococcal; Persistence; hSBA; rSBA.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / immunology*
  • Blood Bactericidal Activity / immunology
  • Child, Preschool
  • Female
  • Humans
  • Immunization, Secondary / methods
  • Male
  • Meningococcal Infections / immunology
  • Meningococcal Vaccines / immunology*
  • Neisseria meningitidis / immunology
  • Serogroup
  • Time Factors
  • Vaccination / methods
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • MenACWY
  • MenACWY-CRM vaccine
  • Meningococcal Vaccines
  • Vaccines, Conjugate

Associated data

  • ClinicalTrials.gov/NCT01148017