About the RSVital Trial
The RSVital Trial is evaluating an investigational vaccine, called mRNA-1345, to determine if it may provide additional protection against RSV in adults aged 60 and older when given as a revaccination.
About RSV
RSV is a highly contagious common cause of respiratory infection across all age groups. Older adults (aged 60 and older) who have other illnesses, like heart and lung diseases, are at a greater risk of having a serious illness if they are infected by RSV. Some of the common symptoms of RSV infection include runny nose, study (blocked) nose, wheezing, cough, sore throat, fever, and shortness of breath.
Arexvy, Abrysvo, and mRNA-1345 are all recommended by the Centers for Disease Control and Prevention for certain US populations as a single dose for protection against RSV disease. They are recommended for all adults aged 75 and older as well as adults 60 to 74 years old who are at increased risk of severe RSV disease.
As protection from RSV disease following vaccination is not lifelong, the RSVital Trial is evaluating the use of mRNA-1345 for revaccination a er a first dose of
either Arexvy or Abrysvo.
“Revaccination” means getting a vaccine again after you’ve already had it. This is done to help maintain protection against certain diseases.
What to Expect
- Participation in the RSVital Trial will last about 6 months and includes:
- Up to 4 visits
- 2 safety phone calls
- At a screening visit, the trial team will review what to expect and decide if the trial is a good fi t for you.
- Those who enroll in the trial will be given 1 injection (shot) in the upper arm. There is no placebo in this trial, so every participant will receive the investigational vaccine.
- There will be up to 3 blood samples taken during the course of the trial.
- Participants will have at least 2 safety phone calls with the trial doctor after the injection to monitor for any side effects.
- Participants will be asked to use an eDiary app on their smartphone or a provided smartphone to report any side effects they might experience for 6 days a er the injection.
Who Can Join?
To join the trial, you must:
• Be at least 60 years old
• Be in generally good health
• Chronic (long-term) medical conditions are allowed if the condition is stable
• Have received an initial dose of either Arexvy or Abrysvo at least 12 months before the first trial visit
The trial doctor will explain additional requirements and answer any questions you may have.
You could help researchers learn more about Moderna’s investigational vaccine that may help to provide additional protection against RSV for older adults.
About the Investigational Vaccine
Normally, vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1345 investigational vaccine is different. It is made from messenger ribonucleic acid (mRNA), a molecule that naturally occurs in the body and tells cells how to make protein. In this case, the protein is a small part of RSV that is thought to help the body’s immune system protect itself if it ever comes across the actual virus.
The investigational vaccine being researched in the RSVital Trial (mRNA-1345) has already been tested in other trials in adults for general safety and effectiveness. It is currently approved by the US Food and Drug Administration (FDA) as a single dose for the prevention of RSV in adults aged 60 and older.
About Vaccine Trials
It is very important to remember the following if you are thinking about joining a vaccine trial:
- The investigational vaccine has not been approved for use in revaccination. This means that researchers are still looking to understand if it will provide additional protection against RSV infection in revaccination.
- All vaccines may have some side effects, and this is also true for the investigational vaccine in this trial. Participants are closely monitored for any side effects throughout trials like this.
- In other trials of people receiving mRNA-1345 as a single dose or repeated dose, the most common side effects were fever, headache, muscle aches or pain, joint aches or pain, nausea or vomiting, and chills. A er the injection, you may have pain or redness and hardness of the skin at the injection site.
- Trial participants have the right to drop out of the trial at any time for any reason. The trial doctor also has the right to discontinue a trial participant at any time for the participant’s safety or if the participant no longer meets the trial requirements
Thank you for your interest in the RSVital Trial.
What Are Clinical Trials?
Clinical trials, also known as clinical studies, and the volunteers who take part in them are vital to learning about investigational medications and treatments. When scientists are developing new medications and treatments, they do not know how well these treatments will work or what side effects may happen. To find out how safe investigational treatments are and how well they work, clinical trials are used to answer questions such as:
- Is the investigational treatment safe enough to outweigh the condition’s risks?
- What is the best dose of the investigational treatment?
- How often should the investigational treatment be given?
- How effective is the investigational treatment at treating symptoms or curing the condition?
Before an investigational treatment can be made available to the public, it must be evaluated in volunteer participants. Therefore, the main purpose of a clinical trial is to look at how investigational treatments work in people. Because the investigational treatment is still being tested, it is important for participants to understand the following:
- They may not experience a direct benefit from the investigational treatment.
- They may experience unknown risks or side effects.
- They are entering a clinical trial that may have different standard medical practices than what they currently know.
For more information about this clinical trial, scan the QR code to visit RSVitalTrial.com
or contact the participating site listed below.
786-772-0510
Diseases do not discriminate — and neither should clinical trials. Moderna is committed to researching safe and effective mRNA-based vaccines and therapies to bring better health and living to people of all ages, sexes, and backgrounds.
