Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks

NARecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

December 6, 2022

Primary Completion Date

December 1, 2025

Study Completion Date

June 1, 2026

Conditions
Pertussis/Whooping Cough
Interventions
BIOLOGICAL

Bordetella pertussis B1917

The B. pertussis isolate to be used in this human colonisation model is strain B1917, which is representative of current isolates in Europe. The strain, isolated in 2000 from a Dutch patient with B. pertussis disease, expresses Pertactin (PRN), Pertussis Toxin (PT) and Filamentous Haemagglutinin (FHA). This strain has been extensively characterised in the mouse model as well as by proteomics and transcriptomics and has a closed genome available. It is fully sensitive to azithromycin in vitro.

DRUG

Azithromycin Pill

A 3 day course of azithromycin will be administered to all colonised volunteers at week 6, or sooner if early pertussis disease is suspected

Trial Locations (1)

SO16 6YD

RECRUITING

NIHR Clinical Research Facility, Southampton

All Listed Sponsors
lead

University of Southampton

OTHER