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Ongoing Clinical Trials for Respiratory Syncytial Virus Infection

This article provides detailed information about 20 ongoing clinical trials focused on Respiratory Syncytial Virus (RSV) infection. These studies are investigating various vaccines and treatments to protect against RSV, particularly in vulnerable populations including infants, older adults, transplant recipients, and pregnant women. Trials are being conducted across multiple countries in Europe and include investigations of vaccines such as Abrysvo, Arexvy, nirsevimab, and several investigational RSV vaccines.

Clinical trial locations

Study on RSV Vaccination with Abrysvo and Arexvy for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

This study is taking place in Belgium and focuses on stem cell transplant recipients who are particularly vulnerable to RSV infections due to their weakened immune systems. The trial compares two vaccines—Abrysvo and Arexvy—to see which provides better protection for this high-risk population.

Who can participate: You must be at least 18 years old and have received an allogeneic stem cell transplant between 3 months and 5 years ago. If your transplant was more than 5 years ago, you can still participate if you’re taking medication for chronic graft-versus-host disease. You’ll need to provide written informed consent to join the study.

Who cannot participate: The study excludes people who are part of vulnerable populations, those outside the specified age range, and individuals who haven’t received the required type of transplant.

Main focus: The study evaluates how well each vaccine stimulates the immune system of transplant recipients to produce antibodies against RSV. Researchers will measure antibody levels at various timepoints and may administer a second dose if the initial response is insufficient. The goal is to determine which vaccine provides better and longer-lasting protection for this vulnerable group.

Investigational treatments: RSVPreF (Abrysvo) is a bivalent vaccine targeting two RSV subgroups using stabilized viral proteins. RSVPreF3 OA (Arexvy) contains the RSV glycoprotein F stabilized in a specific form, combined with an adjuvant to boost immune response. Both vaccines are given as muscle injections.

Study on the Effectiveness of RSV Vaccine (Abrysvo) in Preventing Hospitalizations in Adults Aged 60 and Older

This Danish study examines how well the Abrysvo vaccine prevents serious RSV infections requiring hospitalization in older adults during multiple RSV seasons.

Who can participate: You must be 60 years or older and have signed an informed consent form after understanding the study details.

Who cannot participate: People not infected with RSV, those under age 60, and individuals from vulnerable populations cannot participate.

Main focus: The study tracks hospitalizations due to RSV-related respiratory diseases over multiple RSV seasons (2025/2026 and 2026/2027). Researchers will monitor participants who receive the vaccine to assess how effectively it reduces the risk of hospitalization from RSV-related respiratory tract diseases, cardio-respiratory complications, and overall respiratory infections.

Investigational treatment: Abrysvo is administered as a single muscle injection and works by stimulating the immune system to recognize and fight RSV, potentially reducing the severity of infections and preventing hospitalizations in older adults.

Study on the Immune Response and Safety of an RSV Vaccine in Immunocompromised Patients Aged 18 and Older Using Arexvy and Saline

This Austrian trial focuses on people with weakened immune systems aged 18 and above, comparing the Arexvy vaccine to a placebo to assess immune response and safety.

Who can participate: You must be at least 18 years old with a documented RSV-related condition and able to follow study requirements. You need to provide written consent and can be living independently or in an assisted-living facility with minimal help. People with stable chronic conditions like controlled diabetes or heart disease can participate. Female participants of childbearing potential must use effective birth control and have negative pregnancy tests.

Who cannot participate: The study excludes people who are not immunocompromised, those under 18 years old, and participants unwilling to receive one or two vaccine doses.

Main focus: Researchers evaluate how one or two doses of Arexvy vaccine stimulate antibody production in people with weakened immune systems. The study monitors immune response and safety over 12 months, measuring specific antibodies that fight RSV and tracking any side effects.

Investigational treatment: Arexvy is given as a muscle injection and contains weakened virus components designed to help the body recognize and defend against RSV if exposed later.

Study on the Immune Response and Safety of RSVPreF3 OA Vaccine in Adults Aged 60+ with Respiratory Syncytial Virus Infections

This multi-country trial (Belgium, Czechia, Estonia, Finland, Germany, Italy, Poland, Spain) examines the RSVPreF3 OA vaccine (Arexvy) in older adults, particularly evaluating revaccination strategies.

Who can participate: You must have previously participated in the RSV OA=ADJ-006 study and received either a placebo or single vaccine dose. You should be at least 60 years old and medically stable with conditions like controlled diabetes or heart disease. You must be able to complete diary cards, attend appointments, and use communication devices. Written informed consent is required.

Who cannot participate: People with known allergies to vaccine components, history of severe allergic reactions to any vaccine, those who received other vaccines within 30 days, individuals with weakened immune systems, pregnant or breastfeeding women, and those with current respiratory illness are excluded.

Main focus: The study evaluates immune response and safety when participants receive a revaccination dose before RSV season. Researchers measure RSV-neutralizing antibody levels before and after revaccination to assess how long protection lasts and whether booster doses improve immunity.

Investigational treatment: RSVPreF3 OA vaccine is given as a muscle injection and works by stimulating antibody production to protect against RSV, particularly examining timing of revaccination for optimal protection.

Studying the Effect of Nirsevimab Immunization on Antibody Development After RSV Infection in Healthy Infants

This Netherlands study investigates how nirsevimab immunization affects natural antibody development in infants after RSV exposure.

Who can participate: For the nirsevimab group: healthy infants 0-3 months old born before or at RSV season start, whose parents have decided they will receive nirsevimab immunization. For the control group: healthy children 12-15 months old at RSV season start. Parents must provide signed informed consent after receiving oral and written information.

Who cannot participate: Infants with congenital heart defects, chronic lung disease, immune system conditions, allergies to study medication, those who received blood products or immune globulins in the past 90 days, previous RSV infection, any other RSV vaccine, other vaccines within 14 days, previous participation in RSV vaccine studies, or serious medical conditions that could interfere with the study.

Main focus: The study tracks how nirsevimab affects an infant’s own immune response development over time. Researchers collect blood samples at multiple timepoints (before immunization and at 2, 4, 6, and 12 months afterward) to measure RSV-specific antibody levels and understand how the medication impacts natural immunity development.

Investigational treatment: Nirsevimab (brand name Beyfortus) is a single-dose injection containing ready-made antibodies that protect against RSV by preventing the virus from entering respiratory cells, providing season-long protection.

Study of RSV vaccine immune response persistence and revaccination safety in adult lung and kidney transplant recipients

This trial in Germany, Italy, and Spain evaluates long-term protection and safety of revaccination with Arexvy in transplant recipients.

Who can participate: You must have previously participated in the RSV OA=ADJ-023 study and received 1 or 2 vaccine doses with available immune response data. You should be able to complete diary cards, attend follow-ups, and maintain regular contact. Female participants must use adequate birth control and have negative pregnancy tests. You must have received a kidney or lung transplant more than 12 months ago, be taking anti-rejection medications, and have stable organ function.

Who cannot participate: People who haven’t participated in the parent study, those without transplants, individuals under 18, those with known vaccine allergies, pregnant or breastfeeding women, people who received other vaccines within 14 days or blood products within 3 months, those with severe allergic reactions to vaccines, active uncontrolled medical conditions, other clinical trial participants, those with weakened immune systems unrelated to transplant, or fever within 72 hours before vaccination.

Main focus: The study assesses how long vaccine protection lasts in transplant recipients and evaluates safety of an additional vaccine dose. Researchers monitor immune response through blood samples for up to 24 months, tracking antibody levels and overall health.

Investigational treatment: RSVPreF3 vaccine (Arexvy) is an adjuvanted vaccine designed to protect against RSV types A and B, specifically studied in transplant recipients whose immune systems are weakened by anti-rejection medications.

Study on the Effect of Povidone-Iodine, Hydrogen Peroxide, and Water for Injection on COVID-19, Influenza A, and RSV in Patients

This Spanish study examines how oral antiseptic mouthwashes reduce viral load in saliva for patients with COVID-19, influenza A, or RSV.

Who can participate: You must be over 16 years old with a confirmed diagnosis of COVID-19, influenza A, or RSV, with symptoms appearing less than 5 days ago, and not receiving any antiviral treatment.

Who cannot participate: People without these diagnoses, those outside the age range, participants unable to provide informed consent, those with conditions making participation unsafe, or individuals currently in other clinical trials are excluded.

Main focus: The study measures the immediate effect of different antiseptic mouthwashes on viral load in saliva and tracks how long this effect lasts (up to 7 hours after a single rinse). Researchers analyze saliva samples at different times to quantify viral particles and assess effectiveness in reducing virus presence.

Investigational treatments: Three oral antiseptics are tested as mouthwashes. These include Betadine bucal (containing povidone-iodine) and Agua oxigenada Foret (containing hydrogen peroxide), along with water for injection. They work by disrupting the outer layer of viruses to prevent proper function.

Study on the Effectiveness and Safety of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers

This trial in Finland, Germany, and Spain tests a live attenuated RSV vaccine given as a nasal spray to young children.

Who can participate: Children between 6 months and less than 22 months old who are healthy and born at full term (37 weeks or more of pregnancy).

Who cannot participate: Children with any virus diseases, those outside the age range, participants unwilling to follow study procedures, those who received other investigational drugs or vaccines recently, children with severe allergic reactions history, pregnant or breastfeeding participants, or anyone with conditions the study doctors consider unsafe.

Main focus: The study evaluates vaccine effectiveness in preventing RSV infections during RSV season, monitoring participants for lower respiratory tract disease confirmed through specific testing. Researchers observe safety and immune response over multiple RSV seasons through 2026.

Investigational treatment: RSVt vaccine is a live attenuated vaccine administered as nasal spray in two doses, designed to stimulate immune response against RSV and prevent lung infections in young children.

Study on the Safety and Immune Response of rBCG-N-RSV Vaccine Compared to BCG Vaccine in Adults Over 60 with Respiratory Syncytial Virus (RSV) Concerns

This Greek study compares a new recombinant vaccine targeting both tuberculosis and RSV with the conventional BCG vaccine in older adults.

Who can participate: You must be over 60 years old with stable or controlled chronic diseases, able to follow study procedures, and willing to remain in the area for 6 months. You must provide written informed consent, not have participated in other research for 3 months, agree to avoid elective surgery, be willing to receive HIV test results, and not have received BCG vaccination within the last 10 years.

Who cannot participate: Adults under 60, people with weakened immune systems, those with severe vaccine allergic reactions history, serious chronic illnesses, current clinical trial participants, pregnant or breastfeeding women, those who received live vaccines within 4 weeks, people with drug or alcohol abuse in the past year, or anyone with conditions that could interfere with study results or safety.

Main focus: The study evaluates safety and immune response of the new vaccine compared to conventional BCG vaccine over 6 months, measuring specific immune cell markers and proteins through blood tests.

Investigational treatments: Recombinant BCG Vaccine Expressing RSV Nucleoprotein (rBCG-N-RSV) combines traditional BCG vaccine with RSV virus components to potentially protect against both tuberculosis and RSV. Conventional BCG Vaccine serves as comparison, providing established tuberculosis protection.

Study on the Safety and Tolerability of Sisunatovir in Infants and Children with RSV Infection

This Spain and Poland trial tests sisunatovir, an antiviral medication given as hard capsules to young children with active RSV lower respiratory tract infections.

Who can participate: Infants and children between 1 day and 60 months old, weighing 2.5-23 kg, with positive RSV test (within 48 hours or 72 hours for babies 30 days or younger) and signs of lower respiratory tract infection such as rapid breathing for age, low oxygen levels, increased breathing effort, or abnormal lung sounds. Symptoms must have been present for 5 days or less (7 days for babies 30 days or younger).

Who cannot participate: Participants with known medication allergies, those in other trials within 30 days, people with severe heart/liver/kidney disease, pregnant or breastfeeding women, those with current/recent infections other than RSV, people who received live vaccines within 4 weeks, individuals with compromised immune systems, or anyone unable to comply with study procedures.

Main focus: The study evaluates safety and tolerability of sisunatovir compared to placebo in young children with active RSV infections. Researchers monitor for adverse effects, measure drug levels in blood, and assess overall safety through regular health checks.

Investigational treatment: Sisunatovir (50 mg hard capsules) is an antiviral medication that inhibits RSV virus replication, potentially reducing infection severity.

Summary

These 20 ongoing clinical trials represent a comprehensive effort to develop effective strategies for preventing and treating RSV infections across different populations. Several important patterns emerge from this research landscape:

Spain shows particularly high trial activity with representation in 11 studies, followed by Finland, Germany, Poland, and Italy with multiple trials each. This concentration suggests strong research infrastructure and clinical expertise in these countries for respiratory disease studies.

The trials focus on three main populations: older adults aged 60 and above who face higher risk of severe RSV complications, infants and young children who are naturally vulnerable to the virus, and immunocompromised individuals including transplant recipients whose weakened immune systems make them especially susceptible to serious infections.

Several vaccines appear prominently across multiple trials. Arexvy (RSVPreF3 OA) is being studied in at least 8 trials examining different populations and vaccination strategies. Abrysvo appears in 2 major studies focused on preventing hospitalizations. These established vaccines are being evaluated not only for initial effectiveness but also for optimal revaccination schedules and use in special populations.

The research spans various approaches including preventive vaccines given before RSV season, monoclonal antibodies like nirsevimab that provide passive immunity to infants, antiviral medications like sisunatovir for treating active infections, and even non-traditional approaches such as oral antiseptic mouthwashes.

Many trials specifically address vulnerable populations often excluded from standard vaccine research, including transplant recipients, immunocompromised patients, premature infants, and pregnant women. This focus ensures that prevention strategies will be available for those who need them most.

The trials are examining not just whether treatments work, but practical questions about optimal timing, whether booster doses are needed, how long protection lasts, and whether vaccines can be safely given alongside other immunizations. This real-world focus should provide practical guidance for healthcare providers.

Ongoing Clinical Trials on Respiratory syncytial virus infection

  • Study on the Safety and Effectiveness of MK-1654 for Preventing Respiratory Syncytial Virus (RSV) in Healthy Pre-Term and Full-Term Infants

    Not recruiting

    1 1 1
    Investigated diseases:
    Belgium Denmark Finland France Italy Poland +1

  • Study on the Effectiveness and Safety of EDP-938 for Adults with High-Risk Respiratory Syncytial Virus (RSV) Infection

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia The Netherlands Poland Slovakia Spain

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