Study on the Immune Response and Safety of RSVPreF3 OA Vaccine Alone and with COVID-19 mRNA Vaccine in Adults Aged 50 and Above

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What is this study about?

This clinical trial is focused on studying the immune response and safety of vaccines for two diseases: Respiratory Syncytial Virus (RSV) and COVID-19. The study involves two vaccines: the RSVPreF3 OA investigational vaccine, which is a vaccine for RSV, and the Comirnaty Omicron XBB.1.5 COVID-19 mRNA Vaccine, which targets a specific variant of the COVID-19 virus. The purpose of the study is to evaluate how well the immune system responds to these vaccines when they are given together compared to when they are given separately.

Participants in the study will receive either the RSV vaccine alone, the COVID-19 vaccine alone, or both vaccines together. The study will monitor the immune response, which is how the body defends itself against these viruses, and will also look at the safety of the vaccines, including any side effects that may occur. The study will take place over a period of time, with follow-up visits to check on the participants’ health and the effectiveness of the vaccines.

The study is designed for adults aged 50 years and older. It aims to provide important information on whether receiving both vaccines at the same time is as effective and safe as receiving them separately. This information could help in planning future vaccination strategies for these diseases.

1 initial vaccination

Upon joining the study, you will receive your first vaccination. This involves two injections: one for the RSV vaccine and one for the COVID-19 mRNA vaccine. Both vaccines are administered as injections into the muscle, typically in the upper arm.

The RSV vaccine is a powder and suspension for injection, while the COVID-19 mRNA vaccine is a dispersion for injection. The specific dosage and frequency are determined by the study protocol.

2 monitoring and follow-up

After receiving the vaccines, you will be monitored for any immediate reactions. You will be asked to keep a diary card to record any symptoms or side effects you experience.

You will return for follow-up visits to assess your immune response and overall health. These visits will occur at specified intervals, including one month after the initial vaccination.

3 assessment of immune response

One month after the initial vaccination, your immune response will be evaluated. This involves measuring the levels of antibodies in your blood that target the RSV and COVID-19 viruses.

The study aims to compare the immune response when the vaccines are given together versus when they are given separately.

4 reporting of side effects

You will be asked to report any side effects or adverse events you experience. This includes any reactions at the injection site or systemic symptoms like fever or fatigue.

You will report these side effects for up to 30 days after the vaccination, and any serious adverse events for up to six months.

5 final evaluation

The study will conclude with a final evaluation of your health and immune response. This will occur approximately six months after your last vaccination.

The results will help determine the safety and effectiveness of the vaccines when administered together.

Who Can Join the Study?

Participants must be able to follow the study rules, such as filling out diary cards and attending follow-up visits.
Participants must provide written or witnessed informed consent, meaning they understand and agree to the study procedures before any study-specific actions are taken.
Participants must be male or female and at least 50 years old at the time of the first study intervention.
Participants must be considered medically stable by the investigator at the time of the first vaccination. This includes those with chronic stable medical conditions like diabetes, high blood pressure, or heart disease, whether they are receiving treatment or not.
Participants must live in the general community or in an assisted-living facility that provides minimal help, allowing them to be mainly responsible for their own care and daily activities.
Participants must have received a SARS-CoV-2 vaccine (COVID-19 vaccine) at least 3 months before the study vaccination.
Female participants who cannot have children may join the study. This includes women who have had a hysterectomy (removal of the uterus), bilateral oophorectomy (removal of both ovaries), bilateral salpingectomy (removal of both fallopian tubes), or are post-menopausal (have stopped having periods).
Female participants who can have children may join the study if they have used effective birth control for 1 month before the study intervention and agree to continue using it for at least 1 month after the last vaccination. They must also have a negative pregnancy test on the day of and before the study intervention.

Who Cannot Join the Study?

Patients with any serious illness that could interfere with the study results.
Individuals who have had a severe allergic reaction to any vaccine in the past.
People who are currently participating in another clinical trial.
Anyone who has received any other vaccine within the last 30 days.
Individuals with a weakened immune system, which means their body has a harder time fighting infections.
Pregnant or breastfeeding women.
Anyone with a history of autoimmune diseases, where the body’s immune system attacks its own cells.
People who have received blood products or immunoglobulins in the last 3 months. Immunoglobulins are proteins in the blood that help fight infections.
Individuals with a history of bleeding disorders, which means they bleed more easily than normal.
Anyone with a history of drug or alcohol abuse in the past year.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Stichting European Clinical Research Alliance on Infectious Diseases	Utrecht	The Netherlands
Kormont	Kluisbergen	Belgium

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Amphia Hospital	Breda	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Institute Of Tropical Medicine	Antwerp	Belgium
Hospital Quironsalud Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Gelre Hospitals	Zutphen	The Netherlands
Hospital Universitario Hm Monteprincipe	Boadilla Del Monte	Spain
Mbtzmrab	Mechelen	Belgium
Uvscbsvciw Od Afukzun	Edegem	Belgium
Hcougfbk Ubrhqzdxddqus dx A Cgqmkq	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2024
Spain	Not recruiting	01.07.2024
The Netherlands	Not recruiting	01.07.2024

Trial locations

Investigated drugs:

RSVPreF3 OA investigational vaccine is a vaccine being studied to see how well it helps the body build protection against the respiratory syncytial virus (RSV). This virus can cause lung infections, especially in older adults. The vaccine is designed to help the immune system recognize and fight off the virus if a person is exposed to it in the future. In this trial, researchers are looking at how the immune response to this vaccine compares when it is given alone versus when it is given at the same time as a COVID-19 vaccine.

COVID-19 mRNA vaccine (Omicron XBB.1.5) is a type of vaccine that uses a small piece of genetic material called mRNA to help the body recognize and fight the COVID-19 virus, specifically targeting the Omicron XBB.1.5 variant. The mRNA in the vaccine instructs cells in the body to make a protein similar to one found on the virus, which then triggers an immune response. This helps the body to be prepared to fight the actual virus if exposed in the future. In this study, the vaccine is being tested to see how well it works when given with the RSVPreF3 OA investigational vaccine compared to when it is given alone.

Respiratory Syncytial Virus Infections – Respiratory Syncytial Virus (RSV) infections are caused by a virus that primarily affects the respiratory tract. The virus typically enters the body through the nose or throat and can lead to symptoms such as coughing, sneezing, and fever. In severe cases, it can progress to bronchiolitis or pneumonia, especially in infants and older adults. The infection spreads easily through respiratory droplets when an infected person coughs or sneezes. Symptoms usually appear within 4 to 6 days after exposure and can last for 1 to 2 weeks. The virus can cause repeated infections throughout life, but symptoms are generally milder in older children and adults.

Trial ID:

2023-510196-59-00

Protocol code:

217848

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Immune Response and Safety of RSVPreF3 OA Vaccine Alone and with COVID-19 mRNA Vaccine in Adults Aged 50 and Above

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?