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Study of acellular pertussis vaccine and its effect on whooping cough colonization in healthy adults using controlled human infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying pertussis, also known as whooping cough, a contagious respiratory disease. The study aims to investigate how booster vaccination affects bacterial colonization in the nose after controlled exposure to Bordetella pertussis bacteria. The research compares two different vaccines: Repevax (a combination vaccine that protects against diphtheria, tetanus, pertussis, and polio) and Revaxis (a vaccine that protects against diphtheria, tetanus, and polio).

During the study, participants will receive one of these vaccines as a booster shot. Later, they will be exposed to a carefully controlled amount of pertussis bacteria through the nose. The researchers will then collect samples from the nose over several weeks to check for the presence of bacteria. Participants will receive azithromycin, an antibiotic, as part of the study protocol to ensure safety.

This is a Phase 4 study, which means the vaccines being tested are already approved for use but are being studied to gather additional information about their effects. The study will help understand how vaccination might prevent the bacteria from establishing itself in the nose, which could reduce the spread of whooping cough in communities.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial vaccination

    You will receive one of two types of vaccines through injection:

    - Either Tdap-IPV vaccine (which includes protection against pertussis)

    - Or Td-IPV vaccine (which does not include protection against pertussis)

    The vaccine will be administered as a suspension for injection in a pre-filled syringe

  2. Step 2

    Bacterial challenge

    You will receive a nasal application of Bordetella pertussis (the bacteria that causes whooping cough)

    This procedure is called the bacterial challenge

  3. Step 3

    Monitoring period

    Regular nasal wash samples will be collected between day 3 and day 28 after the bacterial challenge

    These samples will be tested to check if the bacteria are present in your nose

  4. Step 4

    Antibiotic treatment

    You will receive azithromycin treatment

    The medication comes in the form of 500 mg film-coated tablets

    This antibiotic treatment is required according to the study protocol

  5. Step 5

    Final visit

    The study concludes with a final visit on day 28 after the bacterial challenge

    This visit includes the last nasal wash sample collection

Who can join the trial?

7 criteria

  • Must be born before September 1, 2004, and be less than 50 years old at the time of screening
  • Must have received all primary pertussis vaccines (basic whooping cough vaccinations) during childhood
  • Must be able to correctly answer all questions on the pre-consent questionnaire
  • Must be fully fluent in Dutch language
  • Must have a home address in the Netherlands and be able to reach the medical center within 1 hour from their residence
  • Must be able to arrive at the medical center within 3 hours at any time between bacterial inoculation and the day 28 follow-up visit
  • Must be willing to take prescribed antibiotics (medications that fight bacterial infections) after receiving the bacterial inoculation according to the study protocol

Who cannot join the trial?

14 criteria

  • Any history of whooping cough (pertussis) infection
  • Previous vaccination with any pertussis-containing vaccine in the past 5 years
  • Known allergy or severe reaction to any vaccine components
  • Current pregnancy or breastfeeding
  • Any ongoing acute illness or fever
  • Taking medications that affect the immune system (immunosuppressive drugs)
  • History of severe allergic reactions (anaphylaxis)
  • Participation in another clinical trial within the last 30 days
  • Having a condition that weakens the immune system (immunodeficiency)
  • Current respiratory infection or chronic respiratory disease
  • Recent use of antibiotics (within 30 days before the study)
  • History of seizures or neurological disorders
  • Chronic medical conditions that are not well controlled
  • Blood disorders or taking blood-thinning medications
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Investigated drugs

  • Tdap-IPV

    (Tetanus, diphtheria, acellular pertussis, and inactivated polio vaccine) is a combination vaccine that helps protect against four different diseases. It contains inactivated bacteria and viruses that stimulate the immune system to create antibodies against tetanus, diphtheria, whooping cough (pertussis), and polio.

  • Td-IPV

    (Tetanus, diphtheria, and inactivated polio vaccine) is a combination vaccine that protects against three diseases. Unlike Tdap-IPV, this vaccine does not include the pertussis component. It contains inactivated bacteria and viruses that help the body create antibodies against tetanus, diphtheria, and polio.

  • Bordetella pertussis

    is not a medication but a bacterial strain used in this study for controlled human infection to study colonization. It is the bacteria that causes whooping cough and is administered intranasally (through the nose) as part of the research protocol.

What is already known about the treatment

  • Tdap-IPV

    A combination vaccine administered through intramuscular injection that provides protection against tetanus, diphtheria, acellular pertussis, and polio. This vaccine is widely used in medical practice as a booster shot for adolescents and adults, particularly effective in preventing whooping cough (pertussis) transmission. The vaccine works by stimulating the immune system to produce antibodies against these specific pathogens, with the acellular pertussis component targeting specific proteins of the Bordetella pertussis bacteria.

  • Td-IPV

    A combination vaccine given via intramuscular injection that protects against tetanus, diphtheria, and polio, but does not include the pertussis component. This vaccine serves as a standard booster immunization for adults and is commonly used when pertussis protection is not required. The vaccine stimulates the production of protective antibodies against tetanus, diphtheria toxoids, and poliovirus, providing long-term immunity against these diseases.

Investigated diseases

Pertussis - A highly contagious respiratory infection also known as whooping cough. The disease begins with mild cold-like symptoms including runny nose, low fever, and mild cough. After one to two weeks, the illness progresses to severe coughing fits characterized by a distinctive "whooping" sound when breathing in. The coughing episodes can be intense enough to cause vomiting and exhaustion. The infection is caused by the bacteria Bordetella pertussis, which attaches to the tiny hairs in the airways. Symptoms typically develop within 5 to 10 days after exposure to the bacteria.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508416-35-00Protocol codePaNaMa ID: 114794Estimated enrolment99 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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