A Phase 4, Randomised Vaccination Study in Healthy Adults to Investigate the Effects of Acellular… (NCT06903221) | Clinical Trial Compass
Active — Not RecruitingPhase 4
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
Netherlands99 participantsStarted 2024-10-16
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.