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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 (KIM-study)
EU CTIS ID: 2023-508416-35-00
What this study is testing
To investigate 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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is born before 1-9-2004 and < 50 years old on the day of screening (Visit 1; V1)
- Participant has received all primary pertussis vaccines during childhood
- Participant is able to answer all questions of the pre-consent questionnaire correctly
- Participant is fully conversant in the Dutch language
- 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 (V6) until the day 28 post challenge visit (V12)
You likely can't join if
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention
- Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe
- Individuals who have a history of receiving pertussis vaccination in the last 5 years
- Receipt of any non-study vaccine within 14 days, before and after receiving the study vaccine (V2) or Bp inoculation (V6)
- For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study
- Individuals who have inviolable commitments within the study period from V6 until V12 (28 days in total) to make contact with: • infants aged < 1 year • unimmunized children aged < 4 years • pregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact • chronically ill patients (e.g. asthma, COPD, heart diseases)
See the full eligibility criteria
- Participant is born before 1-9-2004 and < 50 years old on the day of screening (Visit 1; V1)
- Participant has received all primary pertussis vaccines during childhood
- Participant is able to answer all questions of the pre-consent questionnaire correctly
- Participant is fully conversant in the Dutch language
- 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 (V6) until the day 28 post challenge visit (V12)
- Participant is willing to take an antibiotic regimen after inoculation with Bp according to the study protocol
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention
- Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe
- Individuals who have a history of receiving pertussis vaccination in the last 5 years
- Receipt of any non-study vaccine within 14 days, before and after receiving the study vaccine (V2) or Bp inoculation (V6)
- For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study
- Individuals who have inviolable commitments within the study period from V6 until V12 (28 days in total) to make contact with: • infants aged < 1 year • unimmunized children aged < 4 years • pregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact • chronically ill patients (e.g. asthma, COPD, heart diseases)
- Individuals who have household contacts working with • infants aged < 1 year • pregnant women
- A confirmed diagnosis of pertussis in the last two years and/or Serum IgG anti-FHA >55.9 IU/mL
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.