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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Skscvnvbr Rnwxmqy Urvowzcxee Mtvwceq Cdhpmz Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.10.2024

Trial locations

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.

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 ID:
2023-508416-35-00
Protocol code:
PaNaMa ID: 114794
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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