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
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.
• Participant (male/female) is born before 1-9-2004 and \< 50 years old on the day of screening
• Participant has received all primary pertussis vaccines during childhood
• Participant is in good health as confirmed by review of medical history and physical examination
• Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby
• Participant is able to answer all questions of the pre-consent questionnaire correctly
• Participant is fully conversant in the Dutch language
• Participant is capable and willing to give personal signed informed consent.
• Participant is able to communicate by both mobile telephone and text messaging
• Participant is willing and available to attend all study visits
• Participant agrees to inform his/her general practitioner (GP) about participation in the study
• Participant agrees to provide access to information regarding their vaccination background
• Participant agrees to provide a treating physician access to all study-related information and data
• Participant is able to arrive within 1h at the Radboudumc from his/her home address. The participant must have a home address and live in the Netherlands
• Participant is able to arrive within 3h at the Radboudumc at any time between Bp inoculation until the day 28 post challenge visit
• Participant is willing to take an antibiotic regimen after inoculation with Bp according to the study protocol
• Participant is willing to use infection control measures during social contact during the study
• Participant is willing to attend to the Radboudumc immediately if they become symptomatic