Study on the Immune Response and Safety of RSVPreF3 OA Vaccine for Respiratory Syncytial Virus in Adults Aged 60 and Older

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What is this study about?

This clinical trial is focused on studying a disease called Respiratory Syncytial Virus (RSV) Infections, which affects the respiratory system, particularly in older adults. The study will use a vaccine known as Arexvy, which is a powder and suspension for injection. This vaccine is designed to help the body build immunity against RSV by using a special protein from the virus, called glycoprotein F, that is stabilized in a form that helps the immune system recognize it better. The vaccine is also combined with an ingredient called AS01E to enhance the immune response.

The purpose of the study is to evaluate how well the vaccine works in generating an immune response, its safety, and how it affects the occurrence of RSV-related respiratory illnesses in adults aged 60 years and older. Participants in the study will receive a single dose of the vaccine, and their immune response will be monitored over time. The study will compare the immune responses of participants from different regions to ensure the vaccine is effective across diverse populations.

Throughout the study, participants will be observed for any side effects or reactions to the vaccine. The study will also track the occurrence of any respiratory illnesses related to RSV. Some participants will receive a placebo for comparison. The study aims to provide valuable information on the vaccine’s effectiveness and safety in preventing RSV infections in older adults.

1 joining the study

Upon joining the study, participants will be required to provide written or witnessed informed consent. This ensures that participants understand the study and agree to take part in it.

Participants must be 60 years of age or older and live in a community setting. They should be able to comply with the study requirements, such as completing diary cards and attending study visits.

2 receiving the vaccine

Participants will receive a single dose of the RSVPreF3 OA investigational vaccine. This vaccine is designed to protect against respiratory syncytial virus (RSV) infections.

The vaccine is administered as a suspension for injection and is given through an intramuscular injection.

3 monitoring and follow-up

Participants will be monitored for any immediate reactions to the vaccine. This includes observing for any side effects at the injection site or systemic reactions within 7 days after receiving the vaccine.

Participants will be required to report any unsolicited adverse events within 30 days after the vaccine administration. Serious adverse events will be monitored up to 6 months after receiving the vaccine.

4 regular assessments

Participants will undergo regular assessments to evaluate the immune response to the vaccine. This includes measuring the levels of antibodies against RSV at baseline, 1 month, and 6 months after vaccination.

Participants may be asked to perform self-swabbing to check for RSV-associated respiratory illnesses, especially if they are part of the study in China.

5 completion of the study

The study is expected to end by May 19, 2025. Participants will be informed about the study results and any relevant findings related to their health.

Participants’ health and safety will be monitored throughout the study duration, and any significant findings will be communicated to them.

Who Can Join the Study?

Adult male or female who is 60 years or older at the time of receiving the study vaccine.
Participants must live in a community setting, meaning they are not in a hospital or long-term care facility.
Participants should be able to follow the study requirements, such as filling out diary cards, attending phone calls or visits, and performing self-swabbing (for participants in China only). If a participant has difficulty with these tasks, they can have help from site staff or a caregiver, but the helper cannot make health decisions for them.
Participants must be considered medically stable by the study doctor at the time of vaccination. This means their health condition is not changing rapidly. People with long-term stable conditions like diabetes, high blood pressure, or heart disease can join if the doctor agrees they are stable.
Participants must provide written or witnessed informed consent, meaning they agree to join the study after understanding what it involves.

Who Cannot Join the Study?

Patients who have a known allergy to any component of the investigational vaccine cannot participate.
Patients with a history of severe allergic reactions, such as anaphylaxis, which is a serious and rapid allergic reaction, are excluded.
Patients who have received any other vaccine within 30 days before the study starts are not eligible.
Patients with a weakened immune system, which means their body has a reduced ability to fight infections, cannot take part.
Patients who are currently participating in another clinical trial are not allowed to join this study.
Patients with any serious health condition that the study doctors believe could interfere with the study results are excluded.
Pregnant or breastfeeding women cannot participate in the study.
Patients who have received blood products or immunoglobulins, which are proteins that help fight infections, within the last 3 months are not eligible.
Patients with a history of drug or alcohol abuse that could affect their ability to follow the study procedures are excluded.
Patients who have had a recent illness or infection that could interfere with the study are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Hospital Universitario De Salamanca	Salamanca	Spain
Rokotetutkimuskeskus Finvac Oy	Tampere	Finland
Gyncentrum Sp. z o.o.	Katowice	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Silmedic Sp. z o.o.	Katowice	Poland
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
Hospital Nuestra Senora De Sonsoles	Avila	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hwakjojl Umbrzovsgz Cbsenei Hpveinnj	Helsinki	Finland
Cwomque Bibsn Kpzqqblwxsa Awuwslocr Mgdee	Elblag	Poland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	12.08.2024
Poland	Not recruiting	12.08.2024
Spain	Not recruiting	12.08.2024

Trial locations

Investigated drugs:

Respiratory Syncytial Virus, Glycoprotein F, Recombinant, Stabilised In The Pre-Fusion Conformation, Adjuvanted With As01E

RSVPreF3 OA investigational vaccine is a vaccine being studied to help protect older adults from illnesses caused by the respiratory syncytial virus (RSV). This virus can lead to serious respiratory infections, especially in people aged 60 and older. The vaccine is designed to boost the body’s immune response against two main types of RSV, known as RSV-A and RSV-B. By enhancing the immune system’s ability to fight these strains, the vaccine aims to reduce the risk of RSV-related respiratory illnesses in older adults. The study is comparing the immune response in older adults from China with those from other countries to ensure the vaccine works effectively across different populations.

Respiratory Syncytial Virus Infections – Respiratory Syncytial Virus (RSV) infections are caused by a virus that primarily affects the respiratory tract. The virus is highly contagious and spreads through droplets from coughs or sneezes. Infections often begin with symptoms similar to a common cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in infants and older adults, such as bronchiolitis or pneumonia. The virus can cause inflammation and obstruction of the small airways in the lungs, leading to difficulty breathing. Recovery from RSV infections can vary, with symptoms typically lasting one to two weeks.

Trial ID:

2023-509455-13-00

Protocol code:

219815

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Immune Response and Safety of RSVPreF3 OA Vaccine for Respiratory Syncytial Virus in Adults Aged 60 and Older

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?