Respiratory syncytial virus (RSV) (>60 years)

Are you at least 60 years old? We are looking for participants in a vaccine trial with the aim of developing a new vaccine to help protect older adults against respiratory syncytial virus (RSV) infection.

What is RSV?
RSV
is a highly contagious virus that can affect anyone and in mild cases resembles the common cold. But RSV can also cause more serious respiratory illness, mainly in older adults and young babies. RSV, like influenza (flu), is seasonal and in temperate climates often occurs during the winter months. RSV and influenza are different viruses; therefore, even if you have been vaccinated against the flu, you may get an RSV infection.


There are currently no approved vaccines for RSV.
The
experimental vaccine is being studied in this clinical trial to see if it can protect adults aged 18 and over from RSV infection.

If you have any further questions about RSV, talk to your doctor.

We are inviting up to 25,000 adults worldwide (and possibly more) to participate in this clinical trial. You may be able to participate if you are at least 60 years old. There are requirements to be met. The study doctor will determine if you meet all the participation requirements at your first visit to the clinic. Before making a decision, we recommend that you discuss this with your GP.

The study lasts 3 years. This depends on where you are participating in the study.

Every study carried out by ANIMA is approved by one of the central independent ethics committees. This ensures that everything is done according to the necessary legal and deontological rules. Your safety when participating in one of our studies is thus optimally guaranteed.

Some medications might have an adverse effect on the experimental RSV vaccine. At each visit, the study doctor will talk to you about the medications you are currently taking or have previously taken
.

The research doctor will answer all your questions about vaccinations that may be permitted during your participation.

Participation in a clinical trial is voluntary. If you choose to participate, you can change your mind at any time and leave the study without losing any benefits or medical care for which you are eligible.

You may have side effects similar to those from vaccines or other injections, such as redness, swelling, pain near the injection site or fever. You may also have other side effects that you should write down on
diary cards and discuss with the study team so they can help you treat any symptoms you may have. Your study doctor will discuss the possible side effects with you.


Frequently asked questions

A clinical study with a new drug must always be conducted according to strict national and international rules and guidelines. The studies that take place at the ANIMA Research Centre are always submitted for approval to one of the Central Ethics Committees of the Flemish universities. Such a committee, consisting of highly specialised doctors, independently assesses whether the proposed study may proceed or not and under what conditions. To this end, they check whether:

  • we have built up our clinical research well and meaningfully
  • our clinical trials do not pose too many risks to the participants
  • we provide the right information to our participants
  • our participants voluntarily agree to participate

Participants sign a consent form confirming their approval to participate. This ensures your safety when participating in one of our studies.

National and international bodies check whether we strictly comply with the applicable rules and guidelines. For our centre, these include the Federal Agency for Medicines and Health Products (FAMHP), the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA).

These bodies carry out the required audits on a regular basis to ensure the safety of the participating patients and the integrity of the studies conducted.

Participation in a clinical study is always free of charge for the patient. Even if it is necessary to stay one night at the ANIMA Research Centre.
Depending on the study, the participant may or may not be reimbursed for his/her participation.

The research programmes carried out by Anima Research Centre are commissioned by internationally renowned pharmaceutical companies.

In terms of logistics, we are usually supported by the largest company in the world in this regard, IQVIA (formerly Quintiles).

The ARC Team is led by Managing Director and Principal Investigator Dr Erik Buntinx, psychiatrist. He has more than 25 years of experience as a Key Opinion Leader in global CNS drug development.

Our intensively trained research team of doctors, including 2 CNS specialists and 2 general practitioners with extensive clinical experience and a thorough knowledge of clinical factors, treat more than 600 patients per week.

Under the leadership of ARC's dedicated site manager Linde Buntinx, PhD in Bio-Medical Sciences, all our studies are coordinated and carried out according to the rules of the art.

All this, of course, ensures that when you participate in such a study, you have the best quality guarantees.

Before a patient can participate in a study with a new medicinal product, the physician in charge will carry out an examination of the patient's general health condition and will check whether the patient is eligible for the study.

From the moment the new medicine is taken, extensive medical examinations are carried out at regular intervals to check that the new medicine is safe and effective.

Depending on the study, several study days are planned during which the patient is examined in detail by a team of doctors and specialised nurses.



Are you +60 years of age?
Is participating in a trial for an experimental RSV vaccine

More info on this study

News release about RSV

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