AuthorisedTherapeutic use (Phase IV)Interventional

The optimal timing of vaccination in pregnancy: a multi-dimensional mechanistic approach to measure immune responses in pregnant women (MATIMMUNE)

The MATIMMUNE study is investigating the best time for pregnant women to get the whooping cough (Tdap) vaccine. Whooping cough can be very serious for newborn babies, so protecting them before they are born is important. This study will look at how the mother's body reacts to the Tdap vaccine when given at different stages of pregnancy. Researchers will measure the levels of protective substances (antibodies) in the mother's blood. They will also check how many of these antibodies pass through the placenta to the baby and are present in breast milk. The aim is to find out which vaccination timing provides the greatest protection for both the mother and her baby against whooping cough.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

University Of Antwerp

Enrolment target

Start

24 Oct 2024

Pregnant

What is this study about?

This study, called MATIMMUNE, is all about understanding the best way to protect newborn babies from whooping cough. Whooping cough, also known as pertussis, can be a very serious illness for young infants, and it can even be life-threatening. Pregnant women in the UK are offered a vaccine, called Tdap, to help protect their babies from whooping cough after they are born. This vaccine helps the mother's body create protective substances called antibodies, which can then pass to the baby before birth.

Doctors know that getting the whooping cough vaccine during pregnancy helps protect the baby. However, this study wants to find out if there's a particular time during pregnancy when it's most effective to have the vaccine. The researchers will be looking very closely at how the mother's immune system, which is her body's defence system, responds to the vaccine. They want to see how many protective antibodies are made, how well these antibodies work, and how many of them successfully travel from the mum to the baby across the placenta.

They will also be looking at what's called 'functional antibody characteristics,' which means how good those antibodies are at fighting the whooping cough germ, and they'll check these levels at different times: before vaccination, after vaccination, at the time of delivery, and then again when the baby is six months old. They will also check if these protective antibodies are present in breast milk. All this information will help doctors recommend the very best time for pregnant women to get the Tdap vaccine to give their babies the strongest possible protection.

Key takeaways

This study investigates the best timing for the whooping cough (Tdap) vaccine in pregnant women.
The goal is to maximise protection for both the mother and her newborn baby.
Researchers will measure the mother's immune response and how many protective antibodies pass to the baby.
Participation involves receiving the Tdap vaccine and giving several blood samples.
The findings could help improve future vaccination guidelines for pregnant women.
You must be at least 18 years old and pregnant to be eligible.

Who may be eligible?

This study is for pregnant women who are at least 18 years old. There isn't an upper age limit mentioned, so women of any age over 18 can take part as long as they are pregnant.

If you are a woman who is currently pregnant and are considering getting the whooping cough vaccine, you might be able to join this study. The study is specifically looking at immune responses in pregnant women.

It's always best to speak to your doctor or the study team to see if you meet all the specific requirements for participation.

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 currently pregnant?
Are you 18 years old or older?
Are you considering getting the whooping cough vaccine during pregnancy?
Are you able to attend appointments for blood tests over several months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the whooping cough (Tdap) vaccine at a specific time during your pregnancy. Researchers will take blood samples from you at several points: before you get the vaccine, again after you've had it, when you give birth, and then a final sample six months after your baby is born. They will also take a blood sample from your baby's umbilical cord at birth and potentially a breast milk sample from you six months after delivery.

These samples will be used to measure different things in your blood, such as protective antibodies and other immune markers. The study will follow you and your immune response for a total of about six months after your baby is born. You'll need to attend scheduled appointments for these blood tests and sample collections.

Potential risks and benefits

Taking part in this study could help doctors understand the best way to protect babies from whooping cough, potentially improving public health guidelines. You will receive the standard whooping cough vaccine during your pregnancy, which is already recommended by health bodies. As with any vaccine, you might experience mild side effects like a sore arm or a slight fever, and blood tests also carry a very small risk of bruising or discomfort. You are free to withdraw from the study at any time without explaining why, and this will not affect your routine 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 the whooping cough vaccine?

It's a vaccine known as Tdap that protects against tetanus, diphtheria, and whooping cough (pertussis). It's offered during pregnancy to protect newborn babies.

Why is this study important for pregnant women?

This study aims to find the best time during pregnancy to have the whooping cough vaccine to give your baby the most protection against this serious illness.

Will I get the whooping cough vaccine if I join?

Yes, you will receive the Tdap whooping cough vaccine as part of the study, at a specific time during your pregnancy.

How many times will I need to give blood samples?

You will need to give blood samples before the vaccine, after the vaccine, at delivery, and six months after your baby is born.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your medical care.