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Pertussis InfectionPhase 4KIMNCT06903221

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

A Phase 4 study testing Tdap-IPV and Td-IPV in people with Pertussis Infection and Pertussis Vaccines, run by Dimitri Diavatopoulos at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Pertussis Infection, Pertussis Vaccines
What is being tested?
Tdap-IPV and Td-IPV
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteNetherlands
Study dates
16 Oct 2024to Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Incapacitated subjects without decision-making capacity.
  • A confirmed diagnosis of pertussis in the last two years and/or serum IgG anti-FHA >56 IU/mL
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention.
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Individuals who are at risk of complications of a prolonged cough, such as individuals with stress urine incontinence, pelvic floor dysfunction or an inguinal hernia
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  • Chronic use of i) immunosuppressive drugs (e.g. systemic steroids, steroid nasal spray or isotretinoin), ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
  • Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
  • Drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset
  • Diabetes mellitus
  • Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe
  • Infection with Bp or any other Bordetella species at the baseline for challenge visit
  • Individuals who have a history of receiving pertussis vaccination in the last 5 years
  • Acute illness within 3 days prior to Bp inoculation (including mild upper respiratory tract infection, common cold, running nose)
  • Any antibiotic treatment within 4 weeks before inoculation
  • Receipt of any non-study vaccine within 14 days, before and after receiving the study vaccine or Bp inoculation
  • 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. Acceptable forms of contraception include:
  • Established use of oral, injected or implanted hormonal methods of contraception
  • Placement of an intrauterine device or intrauterine system
  • Total hysterectomy
  • Barrier methods of contraception (condom or occlusive cap with spermicide)
  • Male sterilisation if the vasectomised partner is the sole partner for the participant
  • True abstinence when this is in line with the preferred and usual lifestyle of the participant
  • Known hypersensitivity to or contra-indications (including co-medication) for use of azithromycin or macrolides, see: azitromycine (oraal) (farmacotherapeutischkompas.nl). This includes: Clinically relevant bradycardia, hypokalemia, hypocalcemia and hypomagnesemia, cardiac arrhythmia or severe heart failure, congenital or acquired QT-prolongation, use of comedication which can cause QT-prolongation or is contraindicated co-medication: for a full list see: azitromycine (oraal) (farmacotherapeutischkompas.nl) - interactions.
  • Participation in any other clinical study (unless observational) in the three months prior to the start of the study or during the study period
  • Being an employee or student of the department of Laboratory Medicine, Radboudumc
  • Any other condition or situation that would, in the opinion of the investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
  • Individuals who have inviolable commitments within the study period during the challenge (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
  • The use of mouthwash during the challenge (35 days)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • RadboudUMC

    Nijmegen

Other trials in Netherlands

About this study

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
Read more

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.

Being tested
Tdap-IPV, Td-IPV
Keywords
Controlled human infection model, Pertussis, Pertussis vaccine, Acellular pertussis vaccine, Tdap-IPV
Medical subject headings
Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tdap-IPVDrug

    Also called acellular pertussis vaccine

    intramuscular injection

  • Td-IPVDrug

    intramuscular injection

Study groups in NCT06903221
Study groupRoleWhat they receive
Tdap-IPV - standard inoculum doseExperimentalParticipants get vaccinated with Tdap-IPV and will be challenged with 10E5 CFU Bordetella pertussis
Receives: Drug: Tdap-IPV
Td-IPV - standard inoculum dosePlacebo comparatorParticipants get vaccinated with Td-IPV and will be challenged with 10E5 CFU Bordetella pertussis
Receives: Drug: Td-IPV
Tdap-IPV - high inoculum doseExperimentalParticipants get vaccinated with Tdap-IPV and will be challenged with 10E6 CFU Bordetella pertussis
Receives: Drug: Tdap-IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 3-28 post challenge

Secondary outcomes (5)

  1. 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

    Measured: Day 0-28 post challenge

  2. 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

    Measured: Day 0-28 post challenge

  3. Safety: unsolicited AEs

    Occurrence and intensity of unsolicited adverse events, from the challenge visit (V6) until day 28 after challenge (V12), per study group

    Measured: Day 0-28 post challenge

  4. 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

    Measured: Day 3-28 post challenge

  5. 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

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start16 Oct 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06903221
Sponsor's protocol ID
2023-508416-35-00
Other IDs
2023-508416-35-00, 2023
Acronym
KIM
Status last verified
May 2026
First submitted
24 Mar 2025
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tdap-IPV and Td-IPV in people with Pertussis Infection and Pertussis Vaccines, run by Dimitri Diavatopoulos at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bordetella pertussis (Bp) colonisation rate (time frame: Day 3-28 post challenge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06903221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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