Can a booster shot stop whooping cough bacteria in its tracks?
NCT ID NCT06903221
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a booster dose of the acellular pertussis vaccine (Tdap-IPV) can reduce the amount of whooping cough bacteria in the nose after intentional exposure. Healthy adults who were vaccinated as children will receive either the Tdap-IPV booster or a control vaccine, then be exposed to the bacteria via nasal drops. Researchers will track who gets colonized and for how long, aiming to understand how well the vaccine prevents infection and spread.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acellular pertussis vaccine (Tdap-IPV)
- What this could lead to
- If successful, this could show that the vaccine reduces how much pertussis bacteria lives in the nose, which may help control its spread.
- What could go wrong
- This is a small, early-phase study in healthy adults, not patients. It uses a controlled infection model, so results may not reflect real-world conditions or lead to immediate changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 infection control measures during social contact during the study * Participant is willing to attend to the Radboudumc immediately if they become symptomatic Exclusion Criteria: * 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 * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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RadboudUMC
Nijmegen, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.