Ongoing Clinical Trials for Respiratory Syncytial Virus Bronchiolitis
Currently, there are 3 ongoing clinical trials investigating treatments and prevention strategies for respiratory syncytial virus bronchiolitis and related infections. These studies are being conducted across multiple European countries and focus on vaccine effectiveness in adults and preventive treatments for high-risk infants.
Clinical trial locations
- Belgium
- Czechia
- Estonia
- Finland
- Germany
- Italy
- Poland
- Spain
Study on the Immune Response and Safety of RSVPreF3 OA Vaccine in Adults Aged 60+ with Respiratory Syncytial Virus Infections
This study is evaluating the Arexvy vaccine (RSVPreF3 OA) in older adults aged 60 and above who previously participated in a related RSV study. The trial aims to understand how well the immune system responds to a booster dose of the vaccine and how long protection lasts.
Who can participate: The study is open to adults who were part of the previous RSV OA=ADJ-006 study and received either a placebo or a single dose of the RSVPreF3 OA vaccine. Participants must be medically stable, though they can have ongoing stable conditions like diabetes, high blood pressure, or heart disease. They should be able to follow study requirements, including filling out diary cards and attending regular check-ups or phone calls. Written consent is required before any study procedures begin.
Who cannot participate: The study excludes anyone with a known allergy to vaccine components or a history of severe allergic reactions to any vaccine. People who received other vaccines within 30 days before the study, those with weakened immune systems, or anyone currently in another clinical trial cannot join. Pregnant or breastfeeding women, individuals with current or recent respiratory illness, and those with conditions that might interfere with study results or safety are also excluded.
What the study involves: Participants will receive a single injection of the RSVPreF3 OA vaccine, with timing depending on group assignment. The study will measure the body’s immune response by checking antibody levels before and after vaccination. Participants will be monitored for 30 days after vaccination for any side effects, and for six months for any serious health events. The study is expected to conclude by September 2026.
The vaccine being tested: RSVPreF3 OA vaccine is designed to help the body produce antibodies that fight off RSV. It contains a special protein from the virus combined with an ingredient that boosts the immune response. This study is examining whether a booster dose can effectively protect older adults during the RSV season.
Study on Preventing Respiratory Issues from RSV Bronchiolitis in Preterm Babies Using Palivizumab
This trial is investigating whether palivizumab (Synagis) can prevent respiratory problems in otherwise healthy babies born prematurely. The study compares health outcomes between preterm infants who receive the treatment and those who do not during the RSV season, which typically runs from November to March.
Who can participate: The study includes babies born between 29 and 35 weeks and 6 days of pregnancy who are generally healthy without major health problems related to premature birth. Babies must be younger than 6 months old at the start of the RSV season on November 1st. Both male and female infants can participate, and parents or legal guardians must provide written permission.
Who cannot participate: Babies with any major health problems related to being born early are excluded. Those outside the specified gestational age range cannot participate. Depending on the study group, babies who have or have not been exposed to palivizumab previously may be excluded from specific groups.
What the study involves: Infants are randomly assigned to one of two groups. Group A receives palivizumab injections according to the study schedule, while Group B does not receive the medication. All participants are monitored throughout the RSV season for respiratory health, including any lung infections and wheezing episodes. The study also tracks hospitalizations, healthcare resource use, and indirect costs like parental work loss due to child illness. The trial is expected to conclude by June 2025.
The medication being tested: Palivizumab is given as an injection into the muscle. It works by binding to a protein on the RSV virus surface, preventing the virus from entering and infecting healthy cells. This medication is classified as a monoclonal antibody and is being studied for its ability to prevent serious RSV infections in high-risk preterm babies.
Study on the Immune Response and Safety of RSVPreF3 Vaccine in Adults 18-49 at Risk for Respiratory Syncytial Virus Compared to Adults 60 and Older
This study is examining the Arexvy vaccine in younger adults aged 18 to 49 who are at increased risk for severe RSV disease due to underlying health conditions. The trial compares their immune response and vaccine safety to that of adults aged 60 and above.
Who can participate: Adults aged 18-49 with at least one stable chronic condition that increases RSV risk can join. Qualifying conditions include chronic lung diseases like COPD, asthma, or cystic fibrosis; chronic heart conditions like heart failure or coronary artery disease; diabetes requiring active treatment for the past six months; or other conditions like chronic kidney disease, liver disease, or neurologic disorders. Participants aged 60 and older with stable chronic conditions or those living independently are also eligible. Women of childbearing potential must use effective birth control and have a negative pregnancy test. Participants or their legal representatives must provide written consent and be able to complete electronic diaries and attend study visits.
Who cannot participate: People with known allergies to vaccine components or a history of severe allergic reactions to vaccines or medications cannot participate. Those who received other vaccines within 14 days before the study, have weakened immune systems, or have a history of autoimmune diseases are excluded. Pregnant or breastfeeding women, anyone who participated in another clinical trial within the last 30 days, and individuals with medical conditions that could interfere with study results or safety are also excluded.
What the study involves: After providing informed consent, participants receive the Arexvy vaccine as an injection into the muscle. They are monitored immediately for any reactions and asked to keep an electronic diary to record symptoms and side effects. Follow-up visits are scheduled to assess health and vaccine effectiveness, with blood samples taken to measure antibody levels against RSV. The study continues for several months, with a final assessment approximately six months after vaccination.
The vaccine being tested: RSVPreF3 OA investigational vaccine is designed to help the immune system recognize and fight off RSV. By stimulating antibody production, the vaccine aims to protect people at higher risk of severe lung infections. This study is evaluating how well the vaccine works in younger at-risk adults compared to older adults, while ensuring it is safe for use.
Summary
The three ongoing clinical trials reflect a comprehensive approach to preventing and managing RSV infections across different age groups and risk categories. Two studies focus on vaccine development using the RSVPreF3 OA formulation (Arexvy) in adult populations, while one examines preventive treatment in vulnerable preterm infants.
Geographically, the vaccine trials for adults are conducted across multiple European countries, with Germany hosting studies for both older adults and younger at-risk populations. The adult vaccine studies are particularly focused on individuals with chronic conditions like COPD, asthma, diabetes, and heart disease. The infant study is being conducted in Italy and specifically targets preterm babies during their first RSV season.
The RSVPreF3 OA vaccine is the primary investigational product in two of the trials, while palivizumab, an established monoclonal antibody treatment, is being evaluated in the preterm infant population. These studies together aim to provide protection across the lifespan, from premature newborns to older adults, addressing the significant health burden of RSV infections in vulnerable populations.
