B-cell responses after intranasal vaccination with the novel attenuated Bordetella pertussis vaccine strain BPZE1 in a randomized phase I clinical trial

Vaccine. 2014 Jun 5;32(27):3350-6. doi: 10.1016/j.vaccine.2014.04.048. Epub 2014 Apr 29.


Despite high vaccination coverage, pertussis is still a global concern in infant morbidity and mortality, and improved pertussis vaccines are needed. A live attenuated Bordetella pertussis strain, named BPZE1, was designed as an intranasal vaccine candidate and has recently been tested in man in a phase I clinical trial. Here, we report the evaluation of the B-cell responses after vaccination with BPZE1. Forty-eight healthy males with no previous pertussis-vaccination were randomized into one of three dose-escalating groups or into a placebo group. Plasma blast- and memory B-cell responses were evaluated by ELISpot against three different pertussis antigens: pertussis toxin, filamentous haemagglutinin and pertactin. Seven out of the 36 subjects who had received the vaccine were colonized by BPZE1, and significant increases in the memory B-cell response were detected against all three tested antigens in the culture-positive subjects between days 0 and 28 post-vaccination. The culture-positive subjects also mounted a significant increase in the filamentous haemagglutinin-specific plasma blast response between days 7 and 14 post-vaccination. No response could be detected in the culture-negatives or in the placebo group post-vaccination. These data show that BPZE1 is immunogenic in humans and is therefore a promising candidate for a novel pertussis vaccine. This trial is registered at ClinicalTrials.gov (NCT01188512).

Keywords: B cells; BPZE1; Live attenuated nasal vaccine; Novel human vaccine; Pertussis; Phase I clinical trial.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intranasal
  • Adult
  • Antibodies, Bacterial / blood
  • Antibody Formation
  • B-Lymphocyte Subsets / immunology
  • B-Lymphocytes / immunology*
  • Bordetella pertussis
  • Humans
  • Immunoglobulin G / blood
  • Immunologic Memory
  • Male
  • Pertussis Vaccine / immunology*
  • Plasma Cells / immunology
  • Vaccines, Attenuated / immunology
  • Whooping Cough / prevention & control*


  • Antibodies, Bacterial
  • Immunoglobulin G
  • Pertussis Vaccine
  • Vaccines, Attenuated

Associated data

  • ClinicalTrials.gov/NCT01188512