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Study of nirsevimab and RSV vaccine (Abrysvo) for prevention of respiratory syncytial virus infection in infants during their first year of life

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on preventing Respiratory Syncytial Virus (RSV) infections, bronchiolitis, and respiratory tract infections in infants. The study examines two different prevention approaches using Beyfortus (nirsevimab) and Abrysvo, which are medications given as injections into the muscle. RSV is a common virus that can cause serious breathing problems in babies, especially during their first year of life.

The purpose of this research is to determine whether giving both an RSV vaccine to pregnant mothers and nirsevimab to their babies at 4 months of age works better than giving only nirsevimab to infants during RSV season. The study will track how well these approaches protect babies from developing RSV-related breathing problems during their first year of life.

Participants will be divided into two groups. In one group, pregnant mothers will receive the Abrysvo vaccine between weeks 32 and 36 of pregnancy, and their babies will later receive Beyfortus at 4 months of age. In the other group, babies will receive only Beyfortus during the RSV season. The babies' health will be monitored throughout their first year of life to check for any breathing problems or infections.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination during pregnancy
If selected for maternal vaccination, you will receive Abrysvo vaccine between weeks 32 and 36 (plus 6 days) of pregnancy
The vaccine is administered as an injection into the muscle
Step 2
Birth and initial assessment
After birth, your infant will be evaluated for participation in the next phase of the study
Basic health measurements will be recorded
Step 3
Infant protection against RSV
Your infant will receive nirsevimab (Beyfortus) as a single injection into the muscle
The injection will be given either at birth (if born during RSV season) or at the start of RSV season
Some infants will receive the injection at 4 months of age (plus or minus 1 month)
The dose will be either 50 mg or 100 mg, depending on your infant's needs
Step 4
Monitoring period
Your infant will be monitored for 12 months after birth
Testing will be needed if your infant shows signs of respiratory infection (runny nose, blocked nose, cough, wheeze, or breathing difficulties)
Tests will include nasal swabs to check for RSV (Respiratory Syncytial Virus)
Any hospital visits or medical care related to respiratory problems will be recorded
Step 5
Safety monitoring
Throughout the study period, any serious health events will be documented
Regular health assessments will be conducted
Oxygen levels will be checked if your infant shows signs of respiratory problems
Step 6
Study completion
The study will conclude after your infant reaches 12 months of age
Final health assessments will be performed
All collected data will be evaluated to assess the effectiveness of the vaccination strategy

Who can join the trial?

11 criteria

Must be a pregnant woman between 32 and 36 weeks plus 6 days of pregnancy
Must be over 18 years of age
Must have social security coverage or equivalent insurance
Must be able to read and complete questionnaires in French or English
Must be willing and able to follow all study requirements
Must provide written informed consent before joining the study (both mother and partner/co-parent when applicable)
Must agree to receive vaccination during pregnancy if assigned to that group
Must agree for their baby to receive nirsevimab (a protective antibody medicine for infants)
Must deliver a live baby if enrolled in the study
Must agree that their data can be used in analysis with related international research
Must be willing to comply with all study procedures and follow-up visits

Who cannot join the trial?

12 criteria

Infants who are not between 0-12 months of age
Infants with known allergies to any components of RSV vaccines (respiratory syncytial virus vaccines)
Babies with severe medical conditions or compromised immune systems
Infants who have received any other RSV prevention treatment in the past
Babies born before 32 weeks of pregnancy (premature births)
Infants with active respiratory infections at the time of enrollment
Babies whose mothers did not receive prenatal care between weeks 32-36 of pregnancy
Infants with known genetic disorders or birth defects affecting the respiratory system
Babies who have previously been hospitalized for respiratory problems
Infants participating in other clinical trials
Babies whose parents/guardians cannot commit to the full study duration
Infants with documented severe reactions to previous vaccinations

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centre Hospitalier Departemental Vendee
La Roche sur Yon, France
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Centre Hospitalier Intercommunal Creteil
Creteil, France
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Centre Hospitalier Metropole Savoie
Chambery, France

Trial locations

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Investigated drugs

Nirsevimab
is a preventive medication designed to protect infants against respiratory syncytial virus (RSV) infection. It's a long-acting antibody that helps the immune system fight against RSV. It can be given to infants either seasonally or at around 4 months of age.
Abrysvo
is a vaccine given to pregnant women to help protect their unborn babies against RSV. It works by helping the mother's body create antibodies that can be passed to the baby before birth. The vaccine is administered during pregnancy between 32 and 36 weeks of gestation.

What is already known about the treatment

Nirsevimab
A monoclonal antibody medication administered through intramuscular injection, specifically designed to prevent respiratory syncytial virus (RSV) infections in infants. This preventive treatment provides passive immunity against RSV for approximately five months and is particularly important during an infant's first RSV season. The medication works by binding to the RSV F protein, preventing the virus from entering cells and causing respiratory infections, and belongs to the class of immunological agents used for viral prevention.
Abrysvo
A maternal RSV vaccine administered during pregnancy between 32 and 36 weeks of gestation, designed to provide protection against respiratory syncytial virus (RSV) for both mother and infant. This vaccine works by stimulating the production of antibodies that can cross the placenta, providing passive immunity to the developing fetus, and belongs to the class of maternal vaccines for respiratory disease prevention. The vaccine helps protect infants during their vulnerable early months when they are at highest risk for severe RSV infection.

Investigated diseases

Respiratory syncytial virus infection
A common viral infection that affects the respiratory tract, particularly in young children and infants. The virus causes inflammation and swelling of the small airways in the lungs. It typically starts with cold-like symptoms including runny nose and cough, which may progress to affect breathing. The infection often occurs seasonally and can spread easily through close contact.
Bronchiolitis
An inflammatory respiratory condition that affects the smallest air passages in the lungs called bronchioles. It causes swelling and mucus buildup in these tiny airways, making breathing difficult. The condition most commonly affects young children and infants. Symptoms typically begin with those similar to a common cold, such as congestion and cough, and may progress to rapid breathing and wheezing.
Respiratory tract infection
An infection that affects the respiratory system, which can involve the upper or lower airways or both. These infections can be caused by various viruses or bacteria affecting the nose, throat, sinuses, airways, or lungs. Common symptoms include cough, congestion, sore throat, and breathing changes. The infection may be accompanied by fever and general discomfort.