NCT06903221

A Phase 4, Randomised Vaccination Study in Healthy Adults to Investigate the Effects of Acellular Pertussis Vaccine on Colonisation with Bordetella Pertussis Using Controlled Human Infection

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Dimitri Diavatopoulos · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to investigate the effect of booster vaccination with acellular pertussis vaccine on colonization with Bordetella pertussis using a controlled human infection model in healthy volunteers. The main questions it aims to answer are: * Whether booster vaccination with Tdap-IPV reduces Bp colonisation after intranasal challenge with the standard Bp inoculum dose compared to the Td-IPV control group * Compare Bp colonisatation in participants vaccinated with Tdap-IPV after intranasal challenge with the standard and a 'high' Bp inoculum dose Research will compare Tdap-IPV vaccination - standard inoculum dose with Td-IPV vaccination - standard inoculum dose, and Tdap-IPV vaccination - standard inoculum dose with Tdap-IPV vaccination - high inoculum dose to see how Tdap-IPV vaccination and the high inoculum dose have an effect on colonisation rate. Participants will be vaccinated with Tdap-IPV or Td-IPV and 2-4 months later challenged with the standard or 'high' inoculum. After challenge there is a follow up visit for 28 days in which they fill in a daily symptom diary and have 6 visits to the hospital.

Conditions

• Pertussis Infection
• Pertussis Vaccines

Interventions

Type	Name	Description
DRUG	Tdap-IPV	intramuscular injection
DRUG	Td-IPV	intramuscular injection

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-10-01
• Completion: 2027-04-01
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: Netherlands