NCT05116241

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

Phase 2b Placebo-Controlled Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess Immunological Response and Safety of a Single Dose BPZE1 With/Without Coadministration of Tdap (Boostrix™)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: ILiAD Biotechnologies · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.

Detailed description

This multi-center, randomized, placebo- and active-comparator-controlled study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease. Healthy school-age children will be randomly assigned to 1 of 3 different study treatment groups to receive the intranasal BPZE1 vaccine, the intramuscular Boostrix vaccine, or both. Subjects will first receive the intranasal vaccine (BPZE1 or placebo) using a small, cone-shaped device that attaches to a syringe and sprays the vaccine into the nose. After a 10-minute waiting period, subjects will receive the intramuscular vaccine (Boostrix or placebo) in the upper arm. As this is the first study in school-age children, a staggered enrollment is planned with the first 45 subjects in the older age group of 11-17 years designated as the safety lead-in cohort. After reactogenicity results from the first 7 days after vaccination of the safety lead-in cohort are reviewed by the safety monitoring committee, the remainder of the subjects will be enrolled. Subjects who choose to take part in a small sub-study of revaccination/attenuated challenge will receive BPZE1 intranasal vaccine (open-label) 3 months after the first vaccination. Safety will be monitored for 6 months after the first vaccination.

Conditions

• Bordetella Pertussis, Whooping Cough

Interventions

Type	Name	Description
BIOLOGICAL	BPZE1 pertussis vaccine and placebo	Live attenuated pertussis vaccine and placebo
BIOLOGICAL	BPZE1 pertussis vaccine and Boostrix	Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine
BIOLOGICAL	Placebo and Boostrix	Tetanus, diphtheria, and aP vaccine and placebo

Timeline

• Start date: 2021-11-11
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2021-11-10
• Last updated: 2025-11-06
• Results posted: 2025-11-06

Locations

16 sites across 3 countries: Australia, Costa Rica, United Kingdom

Regulatory

• FDA-regulated drug study