Impact of Bacterial Expression and Immune Response in the Severity of Pertussis

Summary

The resurgence of pertussis is associated with an evolutionary mechanism under the pressure of current acellular vaccines, with a possible impact on vaccine effectiveness and disease expression. Little is known about the mechanisms involved in the clinical variability of pertussis, including its most severe malignant form observed in infants (mortality between 50-80%). The main challenges are: (i) the lack of knowledge about the gene expression of B. pertussis strains currently circulating during human infection, incorporating evolutionary changes and vaccine-induced selective pressure; (ii) the poor understanding of the variability in clinical expression of pertussis, and (iii) the lack of biomarkers to predict disease severity or prognosis in infants.

An integrative strategy combining a clinical, microbiological, immunological and 'omic' approach from a prospective cohort of children with pertussis will be used to identify

1. 'in situ' expression profiles of B. pertussis genes and proteins incorporating recent evolutionary changes and
2. a systemic and respiratory immune signature in B. pertussis-infected children according to severity.

Results should furthermore serve as a prerequisite for the identification of severity biomarkers and new vaccine antigen candidates taking into account specific immune responses in infants.

Conditions

• Bordetella Pertussis, Whooping Cough

Interventions

BIOLOGICAL

Nasopharyngeal swab

For hospitalized patients : Nasopharyngeal swab (1 aspiration or 2 swabs (1 in each nostril)) For ambulatory patients : Deep nasal swab: 2 swabs (1 in each nostril), or 1 swab only for children for whom taking 2 swabs is complicated.

BIOLOGICAL

Blood samples

For hospitalized patients : 3 to 7.5 ml For ambulatory patients: Fingertip blood sampling

Sponsors & Collaborators

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• Hopital Universitaire Robert-Debre

  collaborator OTHER

• Centre Hospitalier Intercommunal Creteil

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Réseau ACTIV

  collaborator UNKNOWN

• Hôpital Armand Trousseau

  collaborator OTHER

• CHR - Hôpital Roger Salengo

  collaborator UNKNOWN

• Hôpital Nord - APHM

  collaborator UNKNOWN

• Hôpital Louis Mourier

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Hôpital de la Timone

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• Institut Pasteur

  lead INDUSTRY

Principal Investigators

• Julie Toubiana, MD · Institut Pasteur

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-16

Primary Completion

2025-11-16

Completion

2026-11-16

Countries

• France

Study Locations