Active not recruitingPHASE2INTERVENTIONAL

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

This research study is testing a new vaccine called mRNA-1345, which aims to protect against Respiratory Syncytial Virus (RSV). We want to find out how safe and effective this vaccine is for pregnant women. We also want to see if the protection then passes from the vaccinated mum to her baby, checking the baby's safety and immune response after birth. RSV is a common winter virus that can cause breathing problems, especially in young babies and older adults. This study hopes to find a new way to help protect our youngest and most vulnerable population from this illness.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

ModernaTX, Inc.

Enrolment target

360

Start

15 Nov 2023

Estimated completion

27 May 2026

Respiratory Syncytial Virus

What is this study about?

This study is all about a new vaccine, called mRNA-1345, which is being developed to protect against a common winter bug known as Respiratory Syncytial Virus, or RSV. RSV can be quite a mild cold for most people, but for very young babies and older adults, it can sometimes lead to serious breathing difficulties that might need hospital care. This is why finding good ways to protect people, especially babies, is really important.

The main idea behind this study is to see if giving this new vaccine to pregnant women can help protect their babies from RSV once they are born. We'll be looking carefully at whether the vaccine is safe for expectant mothers and whether it helps their bodies make protective antibodies. Then, we'll check if these antibodies pass to the baby, offering them protection in their first few months of life.

By taking part, you could be helping researchers understand more about how to protect future generations of babies from RSV. It's a chance to contribute to medical science and potentially help improve health outcomes for many families.

Key takeaways

This study is testing a new RSV vaccine for pregnant women.
It aims to see if mothers can pass RSV protection to their babies.
Participants will receive either the new vaccine or a dummy injection.
The study involves several check-ups for mum and baby.
It could help protect future babies from serious RSV illness.

Who may be eligible?

This study is open to pregnant women who are between 18 and 39 years old. When you get the vaccine, you'll need to be between 28 and 36 weeks pregnant. You should also be planning to have your baby at a hospital or maternity unit where the study can continue to check on you and your baby.

To join, you'll need to be able to come to all the study appointments and have a way for the study team to get in touch with you, like by phone or email. You'll also need to be receiving regular antenatal care, and continue with it throughout your pregnancy.

There are some reasons why you might not be able to join. For example, if you've had a bad allergic reaction to any previous mRNA vaccines, or if you have certain existing health conditions that the study doctor thinks might make it unsafe for you to take part or affect the study results.

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 between 18 and 39 years old?
Will you be between 28 and 36 weeks pregnant when you get the vaccine?
Are you able to attend all study appointments?
Do you have a way for the study team to easily contact you?
Have you had no serious allergic reactions to previous mRNA vaccines?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable. This will involve talking about your health, checking your pregnancy, and potentially having a scan if you haven't recently had one. If you qualify, you'll receive either the mRNA-1345 vaccine or a placebo (a dummy injection that looks like the vaccine but contains no active medicine). You won't know which one you receive.

After getting the injection, you'll have several check-ups during your pregnancy. Once your baby is born, both you and your baby will have follow-up visits, which will include health checks and some blood tests for you and your baby. The study team will stay in regular contact with you. The full study, from your first visit during pregnancy until your baby's last check-up, will involve a commitment over several months.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is contributing to important research that could lead to a vaccine protecting babies from RSV. For you personally, there's a chance you and your baby might receive protection from RSV if you get the active vaccine. However, there's also a chance you'll receive the placebo and get no direct benefit from the vaccine itself. Potential risks, like with any vaccine, might include temporary side effects such as soreness at the injection site, feeling tired, or a mild fever. The study team will explain all known risks and carefully monitor you and your baby throughout. Remember, deciding to join is completely up to you, and you can withdraw from the study at any time without explaining why, and your medical care will not be affected.

Locations (56)

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

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Verified postcode
Dothan, United States
Abby's Research Institute
Verified postcode
Phoenix, United States
Watching Over Mothers & Babies
Verified postcode
Tucson, United States
Applied Research Center of Arkansas - ClinEdge - PPDS
Verified postcode
Little Rock, United States
Matrix Clinical Research - Gardena
Verified postcode
Gardena, United States
Matrix Clinical Research - Huntington Park
Verified postcode
Huntington Park, United States
Matrix Clinical Research, Inc - Corporate Office
Verified postcode
Los Angeles, United States
Clinical Research Prime - ClinEdge - PPDS
Verified postcode
Idaho Falls, United States
Bingham Memorial Hospital
Verified postcode
Pocatello, United States
Clinical Research Prime - ClinEdge - Rexburg - PPDS
Verified postcode
Rexburg, United States
Velocity Clinical Research - Covington - PPDS
Verified postcode
Covington, United States
Saginaw Valley Medical Research Group LLC
Verified postcode
Saginaw, United States

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common cold-like virus, but it can sometimes cause serious breathing problems, especially for young babies.

What is mRNA-1345?

mRNA-1345 is the name of the new vaccine being tested in this study to prevent RSV. It's an investigational vaccine, meaning it's still being studied.

Will I or my baby definitely get the active vaccine?

No, you will either receive the active vaccine or a placebo. This is standard practice in studies to fairly compare the effects. You won't know which one you receive.

How long will I be involved in the study?

The study will involve visits throughout your pregnancy and then follow-up appointments for both you and your baby after birth, over several months.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.