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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

dTap booster vaccination of health care workers (HC dTap)

This study, called 'HC dTap', investigates how effective a booster vaccine is for healthcare workers against three serious diseases: diphtheria, tetanus, and whooping cough (also known as pertussis). These diseases are caused by bacteria and can be very dangerous. The vaccine used is a standard, approved jab (called Triaxis) that contains tiny parts of the bacteria to help your body build immunity. Researchers are mainly looking at how much protection healthcare workers have against whooping cough before they get the booster and then again after about a month. This helps them understand if the vaccine is boosting existing protection and how strongly the body reacts to it. The goal is to ensure healthcare workers, who are at higher risk, are well protected.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Varsinais-Suomen hyvinvointialue
Enrolment target
100
Start
24 Apr 2024

What is this study about?

This study is focused on a booster vaccination for healthcare workers. The diseases being looked at are diphtheria, tetanus, and whooping cough (pertussis). Diphtheria is a serious infection that can cause breathing problems, heart failure, and nerve damage. Tetanus, often called lockjaw, affects the nervous system, leading to painful muscle spasms and can be life-threatening. Whooping cough is a highly contagious respiratory infection that causes severe coughing fits, especially dangerous for babies and young children.

The vaccine used in this study is a standard, approved booster shot called Triaxis. It helps your body create protection against these diseases by introducing small, safe parts of the bacteria that cause them. This study is considered a 'Phase IV' study, which means the vaccine is already approved and in general use. Researchers are now looking closer at how well it works and how the body responds to it in a real-world setting, specifically in healthcare professionals who may be at a higher risk of exposure.

The main goal of the study is to measure the level of protection against whooping cough (pertussis) in healthcare workers, both before they receive the booster vaccine and about four weeks after. By checking the levels of specific protective substances in their blood (called antibodies), the researchers can understand how much immunity is present and how much it increases after the booster. This information is important for making sure healthcare workers have good protection, which in turn helps protect their patients.

Key takeaways

  • This study looks at a booster vaccine for diphtheria, tetanus, and whooping cough.
  • It's for healthcare workers to understand their protection levels.
  • The vaccine is a standard, approved booster called Triaxis.
  • Researchers will take blood samples before and after the vaccination.
  • Participation lasts about one month from start to finish.
  • The goal is to improve understanding of vaccine protection in healthcare settings.

Who may be eligible?

To be able to take part in this study, participants need to be healthcare workers.

There is no specific upper age limit, but you must be at least 18 years old to join.

Both men and women are welcome to participate in this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a healthcare worker?
  2. Are you at least 18 years old?
  3. Are you comfortable having regular blood samples taken over a month?
  4. Are you available for two study visits approximately one month apart?
Answer every question to see your result.

What does participation involve?

This study is focused on understanding your body's response to a standard booster vaccine. You would receive the Triaxis booster jab, which is a common and approved vaccine for diphtheria, tetanus, and whooping cough. Before getting the vaccine, some blood samples would be taken. Then, about 28 days (roughly four weeks) after your vaccination, more blood samples would be collected. These samples will be checked to measure your levels of protection against whooping cough, tetanus, and diphtheria and how your immune system has reacted. The total duration of your active participation in the study, from your first visit to your last blood sample, would be about one month.

Potential risks and benefits

Taking part in this study could help us better understand the effectiveness of standard vaccines in healthcare workers, potentially improving health guidelines for this group. The vaccine used is a routine one, but like all vaccines, it can have side effects such as soreness, redness, or swelling where the shot was given, or mild fever, headaches, or muscle aches. More serious side effects are very rare. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Finland

Common questions

What is the purpose of this study?

The study aims to see how well a standard booster jab for diphtheria, tetanus, and whooping cough works in healthcare workers by checking their protection levels before and after the vaccine.

What kind of vaccine is being used?

A standard, approved booster vaccine called Triaxis is being used. It helps protect against diphtheria, tetanus, and whooping cough.

Will I have to do anything complicated?

No, it's quite simple. You'll have some blood samples taken before and about a month after receiving the vaccine.

How long will I be involved in the study?

Your active involvement, from your first visit to your final blood test, would last about one month.

Are there any risks to taking part?

Like all vaccines, there might be temporary side effects like soreness at the injection site or mild fever, but serious side effects are very rare.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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