Antibody Persistence in Young Children 5 Years after Vaccination with a Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C Conjugate Vaccine Coadministered with Diphtheria-Tetanus-Acellular Pertussis-Based and Pneumococcal Conjugate Vaccines

Clin Vaccine Immunol. 2016 Jul 5;23(7):555-63. doi: 10.1128/CVI.00057-16. Print 2016 Jul.

Abstract

We evaluated antibody persistence in children up to 5 years after administration of a combined Haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C (MenC)-tetanus toxoid (TT) conjugate vaccine coadministered with a pneumococcal conjugate vaccine. This is the follow-up study of a randomized trial (ClinicalTrials.gov registration no. NCT00334334/00463437) in which healthy children were vaccinated (primary vaccinations at 2, 4, and 6 months of age and booster vaccination at 11 to 18 months of age) with Hib-MenC-TT or a control MenC conjugate vaccine, coadministered with diphtheria-tetanus-acellular pertussis (DTPa)-based combination vaccines (DTPa/Hib for control groups) and a pneumococcal conjugate vaccine (10-valent pneumococcal nontypeable H. influenzae protein D conjugate vaccine [PHiD-CV] or 7-valent cross-reacting material 197 [CRM197] conjugate vaccine [7vCRM]). MenC antibody titers were measured with a serum bactericidal antibody (SBA) assay using rabbit complement (i.e., rabbit SBA [rSBA]), and antibodies against Hib polyribosylribitol phosphate (PRP) were measured with an enzyme-linked immunosorbent assay. Antibody persistence up to 5 years after booster vaccination is reported for 530 children ∼6 years of age. The percentages of children with seroprotective rSBA-MenC titers were between 24.2% and 40.1% in all groups approximately 5 years after booster vaccination. More than 98.5% of children in each group retained seroprotective anti-PRP concentrations. No vaccine-related serious adverse events and no events related to a lack of vaccine efficacy were reported. Approximately 5 years after booster vaccination, the majority of children retained seroprotective anti-PRP antibody concentrations. The percentage of children retaining seroprotective rSBA-MenC titers was low (≤40%), suggesting that a significant proportion of children may be unprotected against MenC disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT00891176.).

MeSH terms

  • Antibodies, Bacterial / blood*
  • Blood Bactericidal Activity
  • Child
  • Child, Preschool
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage*
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Follow-Up Studies
  • Haemophilus Vaccines / administration & dosage*
  • Haemophilus Vaccines / immunology*
  • Heptavalent Pneumococcal Conjugate Vaccine / administration & dosage*
  • Humans
  • Infant
  • Male
  • Neisseria meningitidis, Serogroup C / immunology*
  • Pneumococcal Vaccines / administration & dosage*
  • Randomized Controlled Trials as Topic
  • Tetanus Toxoid / administration & dosage*
  • Tetanus Toxoid / immunology*
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / immunology

Substances

  • 10-valent pneumococcal conjugate vaccine
  • Antibodies, Bacterial
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Haemophilus Vaccines
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Hib-MenCY-TT vaccine
  • Pneumococcal Vaccines
  • Tetanus Toxoid
  • Vaccines, Conjugate

Associated data

  • ClinicalTrials.gov/NCT00334334
  • ClinicalTrials.gov/NCT00891176

Grants and funding

GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the clinical trial conduct and analysis. GlaxoSmithKline Biologicals SA also took in charge all costs associated with the development and the publishing of the manuscript.