RSV is a contagious respiratory virus that can lead to hospitalization and other complications, especially in adults with weakened immune systems.
Pfizer's RSV vaccine (ABRYSVO®) has already helped protect millions of people around the world who are at increased risk of severe illness from RSV. However, people with weakened immune systems may lose vaccine protection faster than others.
This clinical trial will help us learn if receiving another dose of the RSV vaccine is safe and can help people with weakened immune systems maintain protection against RSV.
Who may participate
This study is enrolling adults who:
- Are 18 years of age or older
- Have never received an RSV vaccine OR have received at least 1 dose of Pfizer’s RSV vaccine
- Have a weakened immune system
You may qualify for this study if you meet any of the following criteria for having a weakened immune system:
- Have an autoimmune disease (e.g., rheumatoid or psoriatic arthritis, lupus, scleroderma, etc.) and take medication to regulate your immune system
- Have had certain transplants
- Are receiving or recently completed chemotherapy
The study team will discuss additional requirements with you and help you decide if this study is right for you.
Age
18+ years
Medical history
Have a weakened immune system
Vaccination history
Have never received an RSV vaccine OR have received at least 1 dose of Pfizer's RSV vaccine
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you agree to take part, you will be in the study for about 1 year and have up to 5 visits with the study team.
You will receive 1 injection (shot) of Pfizer’s RSV vaccine. There is no placebo (injection with no active ingredients) in this study.
There is no cost to participate, and health insurance is not required. Compensation for time and travel is available and will be explained by the study team.
Your safety is the most important part of this clinical trial, and your health will be carefully monitored by the study team. You can contact the study team at any time if you have questions or concerns about your health.
Number of vaccine doses
1 dose
Study visit schedule
Up to 5 visits over about 1 year
Study-related costs
No cost to participate, and you will be paid for completing study related activities.
About the study vaccine
The vaccine being studied (ABRYSVO®) is a licensed RSV vaccine developed by Pfizer. The vaccine is approved for use in adults 60 years of age or older, pregnant individuals, and people 18 to 59 years of age who are at increased risk for respiratory illness caused by RSV, including those with weakened immune systems.
Your participation matters
It’s important that everyone has access to vaccines that work for them, regardless of their background. Taking part in this clinical trial will help researchers learn more about the RSV vaccine and how it works for different people.
With your help, we can advance research that may offer additional protection against RSV for people with weakened immune systems.
About respiratory syncytial virus
Respiratory syncytial virus (RSV) is a common virus that infects the nose, throat, and lungs. It usually spreads in the fall and winter and causes flu-like symptoms such as stuffy or runny nose, cough, and fever. When healthy adults get RSV, their symptoms are usually mild. However, RSV can make some people seriously ill and lead to complications like pneumonia (an infection of the lungs).
While anyone can get RSV, some people have a higher risk of severe illness including infants, people with certain medical conditions or a weakened immune system, and older adults. Fortunately, there are RSV vaccines now available that can help prevent serious illness for those at greatest risk.
Frequently asked questions
You will receive 1 dose of an RSV vaccine which could help protect you from serious illness, and your health will be closely monitored by the study team. You will also be contributing to research that may strengthen vaccine protection against RSV for those who need it most.
As with any vaccine, local reactions at the injection site can be common – such as tenderness, redness, or swelling. There is also potential for other symptoms like fatigue (tiredness), headache, muscle pain, joint pain, or more serious side effects including an allergic reaction. Study-related blood draws may cause discomfort, bruising, bleeding, and in rare cases, infection. There may be other risks that are unknown at this time. The study team will provide more information about the potential benefits and risks of taking part.
While all clinical trials come with some risks, participant safety is always the top priority. Clinical trials are reviewed by committees responsible for protecting the rights and safety of all participants. These committees continue to regularly review the trial’s progress to ensure there are no unnecessary or excessive risks to participants.
At the beginning of the clinical trial, the study doctor will ask about your medical history, including your medical conditions, previous vaccinations, and any medications you are currently taking. You will have your blood drawn up to 5 times throughout clinical trial. The study team will give you more information about all tests and procedures during your first study visit.
You will use an electronic diary (eDiary) to report any changes in your health every day for at least 7 days after receiving the study vaccine, or up to 30 days if symptoms persist. You will also receive a thermometer to measure your temperature and a device to measure any redness or swelling that happens at the injection site. The study team will provide more information about the eDiary during your first study visit.
Participation is your choice. You can leave the clinical trial at any time, for any reason. Your decision to stop the study will not affect your regular medical care.
