NCT05461131

Pertussis Challenge Study in Adults Vaccinated With BPZE1

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: ILiAD Biotechnologies · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Pertussis/Whooping Cough
• Bordetella Pertussis, Whooping Cough

Interventions

Type	Name	Description
BIOLOGICAL	BPZE1	Live attenuated vaccine
BIOLOGICAL	Placebo	Placebo
DRUG	Azithromycin	Antibiotic
OTHER	Bordetella Pertussis Challenge Strain	Challenge Strain

Timeline

• Start date: 2022-06-20
• Primary completion: 2023-07-25
• Completion: 2023-10-26
• First posted: 2022-07-15
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study