Five-year antibody persistence and safety following a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine

Pediatr Infect Dis J. 2012 Oct;31(10):1074-7. doi: 10.1097/INF.0b013e318269433a.

Abstract

Background: Booster vaccination with the combined Haemophilus influenza type b-Neisseria meningitides serogroup C-tetanus toxoid vaccine (Hib-MenC-TT) has been reported to induce different MenC antibody responses depending on the priming vaccines, with a possible impact on long-term protection. Here, the five-year persistence of immune responses induced by a booster dose of Hib-MenC-TT was evaluated in toddlers primed with either Hib-MenC-TT or MenC-TT.

Methods: This is the follow-up of a phase III, open, randomized study, in which a Hib-MenC-TT booster dose was given at 13.14 months of age to toddlers primed with either 3 doses of Hib-MenC-TT or 2 doses of MenC-TT in infancy. Children in the control group had received 3 primary doses and a booster dose of MenC-CRM197. Functional antibodies against MenC were measured by a serum bactericidal assay with rabbit complement (rSBA-MenC) and antibodies against Hib polyribosylribitol phosphate by enzyme-linked immunosorbent assay. Serious adverse events considered by the investigator to be possibly related to vaccination were to be reported throughout the study.

Results: At 66 months postbooster, rSBA-MenC titers ≥8 were retained by 82.6% of children primed with Hib-MenC-TT, 94.1% of children primed with MenC-TT, and 60.9% of children in the control group. All children who received the Hib-MenC-TT booster dose retained anti- polyribosylribitol phosphate concentrations ≥0.15 μg/mL. No serious adverse events considered possibly related to vaccination were reported.

Conclusions: There is evidence of good antibody persistence against MenC and Hib for more than five years postbooster vaccination with Hib-MenC TT in toddlers primed with Hib-MenC-TT or MenC-TT.

Trial registration: ClinicalTrials.gov NCT00322335.

Publication types

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

MeSH terms

  • Antibodies, Bacterial / blood
  • Blood Bactericidal Activity
  • Child
  • Child, Preschool
  • Complement System Proteins / immunology
  • Enzyme-Linked Immunosorbent Assay
  • Follow-Up Studies
  • Haemophilus Vaccines / administration & dosage
  • Haemophilus Vaccines / adverse effects*
  • Haemophilus Vaccines / immunology*
  • Haemophilus influenzae type b / immunology
  • Humans
  • Immunization, Secondary / adverse effects
  • Immunization, Secondary / methods*
  • Infant
  • Male
  • Meningococcal Vaccines / administration & dosage
  • Meningococcal Vaccines / adverse effects*
  • Meningococcal Vaccines / immunology*
  • Neisseria meningitidis, Serogroup C / immunology
  • Tetanus Toxoid / administration & dosage
  • Tetanus Toxoid / adverse effects*
  • Tetanus Toxoid / immunology*
  • Time Factors
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / adverse effects
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • Haemophilus Vaccines
  • Meningococcal Vaccines
  • Tetanus Toxoid
  • Vaccines, Conjugate
  • Complement System Proteins

Associated data

  • ClinicalTrials.gov/NCT00322335