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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
99
RadboudUMC
Nijmegen, Netherlands
Bordetella pertussis (Bp) colonisation rate
Bp colonisation rate in Tdap-IPV and Td-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge
Time frame: Day 3-28 post challenge
Safety: solicited adverse events (AEs)
Occurrence and intensity of respiratory and systemic symptoms of pertussis disease, from the challenge visit (V6) until day 28 after challenge (V12), per study group
Time frame: Day 0-28 post challenge
Safety: azithromycin treatment
Proportion of participants, per study group, that receive azithromycin treatment after Bp challenge (V6) and before day 28 (V12) as a result of development of early symptoms of pertussis disease
Time frame: Day 0-28 post challenge
Safety: unsolicited AEs
Occurrence and intensity of unsolicited adverse events, from the challenge visit (V6) until day 28 after challenge (V12), per study group
Time frame: Day 0-28 post challenge
Colony forming unit (CFU) counts
Bacterial load, defined as the number of colony forming units (CFUs) of Bp per ml detected in nasal wash of challenged participants at each sampling timepoint from day 3 (V7) until day 28 after challenge (V12), per study group
Time frame: Day 3-28 post challenge
Geometric mean concentration of Bp-specific antibodies
Geometric mean concentration of Bp-specific antibodies in blood and mucosal samples at vaccination baseline (V2), 28 days post vaccination (V4), challenge baseline (V5) and 28 days post challenge (V12), per study group
Time frame: 5 months
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