Antibody persistence up to 5 y after vaccination with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in adolescents

Hum Vaccin Immunother. 2017 Mar 4;13(3):636-644. doi: 10.1080/21645515.2016.1248009. Epub 2017 Feb 2.

Abstract

Long-term protection against meningococcal disease relies on antibody persistence after vaccination. We report antibody persistence up to 5 y after vaccination in adolescents who received a single dose of either meningococcal serogroups A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT, Pfizer) or MenACWY polysaccharide vaccine (MenPS, GSK Vaccines) at the age of 11-17 y in the randomized controlled primary study NCT00464815. In this phase III, open, controlled, multi-center persistence follow-up study conducted in India and the Philippines (NCT00974363), antibody persistence was evaluated by a serum bactericidal antibody assay using rabbit complement (rSBA) yearly, up to year 5 after vaccination. Serious adverse events (SAEs) related to study participation were recorded. Five years after a single dose of MenACWY-TT, the percentage of participants (N = 236) with rSBA titers ≥1:8 was 97.5% for serogroup A, 88.6% for serogroup C, 86.0% for serogroup W and 96.6% for serogroup Y. The percentages in the MenPS group (N = 86) were 93.0%, 87.1%, 34.9% and 66.3%, respectively. Exploratory analysis indicated a higher percentage of subjects with rSBA titers ≥1:8 for serogroups W and Y, and higher rSBA geometric mean antibody titers for serogroups A, W and Y in the MenACWY-TT group than the MenPS group at each time point (years 3, 4 and 5). No differences between groups were observed for serogroup C. No SAEs related to study participation were reported. In conclusion, the results of this follow-up study indicate that antibodies persisted up to 5 y after a single dose of MenACWY-TT in adolescents.

Keywords: Neisseria meningitidis; adolescents; antibody persistence; conjugate vaccine; quadrivalent meningococcal vaccine.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Animals
  • Antibodies, Bacterial / blood*
  • Blood Bactericidal Activity
  • Child
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • Follow-Up Studies
  • Humans
  • India
  • Male
  • Meningococcal Vaccines / administration & dosage*
  • Meningococcal Vaccines / adverse effects
  • Meningococcal Vaccines / immunology*
  • Philippines
  • Rabbits
  • Time Factors
  • Young Adult

Substances

  • Antibodies, Bacterial
  • Meningococcal Vaccines