Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Maternal determinants of infant immunity to pertussis (MADI-02)

The MADI-02 study is investigating how mothers' vaccinations protect their babies from whooping cough. Whooping cough is a serious illness, especially for young infants. Researchers are looking closely at the immune system, specifically the 'antibody responses,' after expectant mothers receive a whooping cough vaccine. They want to understand which vaccines are most effective at boosting a mum's immunity, so this protection can then be passed on to her baby. This research aims to find better ways to keep babies safe from whooping cough by improving vaccination for mums.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Universite Libre de Bruxelles

Enrolment target

240

Start

16 Oct 2024

Whooping cough

What is this study about?

This research study, known as MADI-02, is all about understanding how pregnant mothers can best protect their newborns from whooping cough. Whooping cough, also called pertussis, is a highly contagious and serious breathing infection that can be very dangerous for babies, often leading to hospitalisation or worse. The good news is that mothers can pass on some protection to their babies if they get vaccinated during pregnancy. This study wants to find out the best way for this to happen.

Researchers are particularly interested in seeing how mothers' bodies react to the whooping cough vaccine. When you get a vaccine, your body makes special defenders called 'antibodies.' These antibodies learn to fight off the illness. The study will look at how many of these antibodies are made, how good they are at fighting whooping cough, and whether they can effectively cross from the mother to her baby, providing valuable early protection.

By carefully studying these immune responses, the MADI-02 team hopes to learn which vaccines or vaccination strategies work best to maximise the protection passed from mum to baby. This information could help doctors and health organisations make better recommendations for pregnant women, ultimately leading to fewer babies getting sick with whooping cough and offering them a healthier start in life.

Key takeaways

This study helps protect babies from whooping cough.
It examines how mums' vaccines pass on protection to their babies.
Two existing, approved whooping cough vaccines are being studied.
Participation involves receiving a vaccine and giving blood samples.
The research aims to improve infant immunity through maternal vaccination.

Who may be eligible?

To join this study, participants must be adult women, meaning they must be 18 years old or older. There is no upper age limit, so women of any age above 18 can take part.

The study welcomes all women, regardless of their background or other personal characteristics, as long as they meet the age requirement. Specific details about health conditions or other factors needed for the study would be discussed with the research team.

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.

Are you 18 years old or older?
Are you female?
Are you currently pregnant or planning pregnancy soon? (This is implied by the 'Maternal' aspect, but not explicitly stated in the raw eligibility, so this is a reasonable assumption for a patient-facing checklist.)
Are you generally in good health and able to attend clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive one of two common whooping cough vaccines: Vaxelis or Triaxis. These vaccines are given as an injection, usually in the arm, just like a regular vaccination. The study will involve several visits to the clinic where researchers will take blood samples. These samples will help them measure your body's immune response to the vaccine.

Throughout the study, the research team will keep track of your health and any effects the vaccine might have. There will be follow-up appointments to monitor your antibody levels over time. The total length of your involvement in the study will depend on the specific schedule designed by the researchers, but it's important to be prepared for multiple visits and assessments.

Potential risks and benefits

Taking part in this study might offer you the benefit of knowing more about your immune response to the whooping cough vaccine. Your participation will also directly contribute to scientific knowledge that could help prevent whooping cough in other babies. As with any vaccine, there's a chance of mild side effects like soreness, redness, or swelling where you had the injection, or feeling a bit under the weather. Serious side effects are very rare. You have the right 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.

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Unverified
Belgium

Common questions

What is whooping cough?

Whooping cough, or pertussis, is a serious and highly contagious chest infection that can be very dangerous for babies.

Why is this study important for babies?

It helps researchers understand how mothers' vaccines protect their babies from whooping cough, potentially leading to better protection for newborns.

Will I get a new or experimental vaccine?

No, the study uses widely used and approved whooping cough vaccines, Vaxelis and Triaxis, which are already available.

What will I have to do if I join?

You'll receive a whooping cough vaccine and have blood samples taken at different times to check your immune response.

Can I leave the study at any point?

Yes, you are free to leave the study at any time without giving a reason, and it won't affect your medical care.