Clinical Trial

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

Study acronym: PERT-SEVEREII
Recruiting
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Record status
This record was last updated May 24, 2024 (before its estimated November 16, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-06-01.
Status change: Not Yet Recruiting → Recruiting 2024-05-22
Trial Details
NCT Number NCT05897879
Lead Sponsor Institut Pasteur
Collaborators: Hôpital Necker-Enfants Malades, Hospices Civils de Lyon, Hopital Universitaire Robert-Debre, Centre Hospitalier Intercommunal Creteil, Nantes University Hospital, Réseau ACTIV, Hôpital Armand Trousseau, CHR - Hôpital Roger Salengo, Hôpital Nord - APHM, Hôpital Louis Mourier, University Hospital, Toulouse, University Hospital, Bordeaux, Hôpital de la Timone, University Hospital, Rouen
Conditions Bordetella Pertussis, Whooping Cough
Enrollment 210 participants
Start Date 2023-11-16
Primary Completion 2025-11-16 (estimated)
Study Completion 2026-11-16 (estimated)
Updated on ClinicalTrials.gov 2024-05-24