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

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

Author information

1
Public Health Agency of Sweden, Solna, Sweden; Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden. Electronic address: maja.jahnmatz@folkhalsomyndigheten.se.
2
Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
3
Public Health Agency of Sweden, Solna, Sweden.
4
Institut Pasteur de Lille, Center for Infection and Immunity of Lille, Lille, France; Inserm U1019, Lille, France; CNRS UMR8204, Lille, France; University Lille Nord de France, Lille, France.

Abstract

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

PMID:
24793938
DOI:
10.1016/j.vaccine.2014.04.048
[Indexed for MEDLINE]
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