Primary Vaccination With the 10-valent Pneumococcal Non-Typeable Haemophilus Influenzae Protein D Conjugate Vaccine (PHiD-CV) in Infants in Mali and Nigeria: A Randomized Controlled Trial

BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.

Abstract

Background: Pneumonia is still the leading cause of death among children in Africa, and pneumococcal serotypes 1 and 5 are frequently isolated from African children with invasive pneumococcal disease below the age of 5 years. The immunogenicity, safety and reactogenicity of 3-dose primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in infants in Mali and Nigeria.

Methods: In an open, randomized, controlled study, 357 infants received DTPw-HBV/Hib and OPV primary vaccination with (PHiD-CV group) or without (control group) PHiD-CV co-administration at 6, 10 and 14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity (OPA) were measured and adverse events (AEs) recorded.

Results: One month post-dose 3, ≥ 97.2% of PHiD-CV-vaccinated infants had an antibody concentration ≥ 0.2 μg/mL for each vaccine pneumococcal serotype except for 6B (82.0%) and 23F (87.6%) versus < 10% in the control group except for serotypes 14 (35.7%) and 19F (22.5%). For each vaccine serotype, ≥ 93.3% of PHiD-CV recipients had an OPA titre ≥ 8, except for serotypes 1 (87.6%) and 6B (85.4%), compared to < 10% in the control group, except for serotypes 7F (42.9%), 9V (24.1%) and 14 (24.5%). Anti-protein D geometric mean antibody concentrations were 3791.8 and 85.4 EL.U/mL in the PHiD-CV and control groups, respectively. Overall incidences of solicited and unsolicited AEs were similar between groups.

Conclusions: In sub-Saharan African infants, PHiD-CV was immunogenic for all vaccine pneumococcal serotypes and protein D. Vaccine tolerability was generally comparable between the PHiD-CV and control groups.

Trial registration: ClinicalTrials.gov identifier: NCT00678301.

Publication types

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

MeSH terms

  • Africa South of the Sahara
  • Bacterial Proteins / drug effects
  • Bacterial Proteins / immunology*
  • Carrier Proteins / drug effects
  • Carrier Proteins / immunology*
  • Female
  • Haemophilus Infections / prevention & control*
  • Haemophilus influenzae / drug effects
  • Haemophilus influenzae / immunology*
  • Humans
  • Immunoglobulin D / drug effects
  • Immunoglobulin D / immunology*
  • Infant
  • Lipoproteins / drug effects
  • Lipoproteins / immunology*
  • Male
  • Mali
  • Nigeria
  • Pneumococcal Vaccines / administration & dosage
  • Pneumococcal Vaccines / pharmacology
  • Pneumococcal Vaccines / therapeutic use*
  • Primary Prevention*

Substances

  • 10-valent pneumococcal vaccine
  • Bacterial Proteins
  • Carrier Proteins
  • Immunoglobulin D
  • Lipoproteins
  • Pneumococcal Vaccines
  • glpQ protein, Haemophilus influenzae

Associated data

  • ClinicalTrials.gov/NCT00678301