Pertussis Challenge Study in Adults Vaccinated With BPZE1 — CHAMPION-1  

Bordetella Pertussis, Whooping Cough Clinical Trial

Official title: A Phase 2b, Placebo-Controlled, Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy Adults to Assess Protection Against Colonization Following Challenge With Virulent Wild-Type Bordetella Pertussis

Status Completed

Clinical Trial Summary

This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.

Clinical Trial Description

This Phase 2b challenge study will investigate colonisation rates, immunologic response, and the safety of BPZE1 vaccination to potentially protect against colonising, virulent wild-type B. pertussis infection in healthy adults using a virulent challenge model. Consenting, eligible participants will receive a single dose of BPZE1 or placebo. 2-4 months later they will be challenged with B. pertussis and admitted to a challenge unit. Participants will remain in the challenge unit for a total of 17 days and 16 nights during which time they will be monitored closely. If a participant develops symptoms of pertussis (per investigator discretion), antibiotic (azithromycin) will be started and the participant will remain in the unit for 3 additional days of observation before discharge. If symptoms of pertussis do not develop, then participants will receive antibiotic (azithromycin) from Days 14-16 of the challenge unit stay. Participants will undergo safety follow-up for at least 6 months post-vaccination and at least 3 months post-challenge, for a total follow-up of 6-7 months. ;

Related Conditions & MeSH terms

• Bordetella Pertussis, Whooping Cough
• Cough
• Pertussis/Whooping Cough
• Whooping Cough

• NCT number: NCT05461131
• Study type: Interventional
• Source: ILiAD Biotechnologies
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2022
• Completion date: October 26, 2023