This clinical trial is focused on studying a disease called Respiratory Syncytial Virus (RSV) infections, which can cause respiratory illnesses, especially in older adults. The study will use a vaccine known as Arexvy, which is designed to help the body build protection against RSV. This vaccine is given as an injection and contains a special protein from the virus, combined with an ingredient that helps boost the body’s immune response.
The purpose of the study is to evaluate how well the vaccine works and how safe it is for people aged 60 and above. Participants in the study will receive the vaccine at different times to see how their immune systems respond. Some participants will receive a single dose of the vaccine, while others will receive a revaccination dose before the RSV season. The study will monitor the immune response by measuring the levels of protective substances in the blood before and after vaccination.
Throughout the study, participants will be observed for any side effects or health changes. The study will also track any serious health events that occur after vaccination. This research aims to understand the best vaccination schedule to protect older adults from RSV infections effectively.
1joining the study
Upon joining the study, participants will be required to provide written or witnessed informed consent. This is a formal agreement to participate in the study after understanding all the procedures involved.
Participants must have been part of the previous RSV OA=ADJ-006 study and either received a placebo or a single dose of the RSVPreF3 OA vaccine.
2initial assessment
Participants will undergo an initial assessment to ensure they are medically stable. This includes checking for chronic stable medical conditions such as diabetes, hypertension, or cardiac disease.
The investigator will determine if participants can comply with the study requirements, such as completing diary cards and attending regular phone calls or study site visits.
3vaccination
Participants will receive a single dose of the RSVPreF3 OA vaccine, which is a vaccine against respiratory syncytial virus. The vaccine is administered as a suspension for injection through intramuscular use.
The timing of the vaccination depends on the group assignment: either before Season 4 or before Season 5.
4follow-up period
After vaccination, participants will be monitored for a 30-day follow-up period. During this time, any unsolicited adverse events (AEs) will be recorded.
Participants will also be monitored for serious adverse events (SAEs) and potential immune-mediated diseases (pIMDs) from the day of vaccination up to six months after vaccination.
5immunogenicity assessment
The study will evaluate the immune response by measuring RSV-A and RSV-B neutralizing titers before and after vaccination. This involves checking the levels of antibodies that can neutralize the virus.
For the RSV_PreS4 group, this assessment occurs before revaccination and 30 days post-revaccination. For the RSV_PreS5 group, it includes additional assessments at pre-Season 5 and pre-Season 6.
6study completion
The study is estimated to end by September 30, 2026. Participants will continue to be monitored for any SAEs or pIMDs related to the study vaccination until the study concludes.
Participants will be informed of the study results and any relevant findings related to their health.
Who Can Join the Study?
Participants must be male or female who were previously part of the RSV OA=ADJ-006 study and received either a placebo (a harmless pill or injection with no active medicine) or a single dose of the RSVPreF3 OA vaccine.
Participants should be able to follow the study requirements, such as filling out diary cards, attending regular phone calls or study site visits, and using a phone or other electronic communication devices. If a participant cannot fill out the diary cards due to physical limitations, they can have help from site staff or a caregiver, but these helpers cannot make health decisions for the participant.
Participants must provide written or witnessed informed consent before any study-specific procedures are performed. This means they agree to participate after understanding the study details.
Participants should be medically stable at the start of the study, as judged by the investigator. This means their health condition is not changing rapidly. Participants with ongoing stable medical conditions, like diabetes, high blood pressure, or heart disease, can join the study.
Who Cannot Join the Study?
Patients who have a known allergy to any component of the vaccine cannot participate.
Individuals with a history of severe allergic reactions, also known as anaphylaxis, to any vaccine are excluded. Anaphylaxis is a serious and rapid allergic reaction that can be life-threatening.
Participants who have received any other vaccine within 30 days prior to the study start date are not eligible.
People with a weakened immune system, which means their body has a reduced ability to fight infections, cannot take part in the study.
Individuals currently participating in another clinical trial are not allowed to join this study.
Pregnant or breastfeeding women are excluded from participating in the trial.
Anyone with a current or recent respiratory illness, which affects the lungs and breathing, is not eligible.
Participants with any condition that, in the opinion of the study doctor, might interfere with the results of the study or the safety of the participant are excluded.
RSVPreF3 OA vaccine is a vaccine designed to protect against respiratory syncytial virus (RSV) in older adults. This vaccine works by stimulating the body’s immune system to produce antibodies that can fight off the virus if the person is exposed to it in the future. In this clinical trial, the vaccine is being tested to see how well it works when given as a single revaccination dose before the RSV season, and to check how long the protection lasts in adults aged 60 years and above.
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 the infection can take several weeks, with symptoms gradually improving over time.
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