Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults

This study is looking into a new vaccine called mRNA-1345, designed to protect people from Respiratory Syncytial Virus (RSV). RSV is a common infection that can be more serious for certain individuals. The main goals of this research are to find out if the vaccine is safe and how effectively it helps the body build protection against RSV. The study is split into two parts. The first part focuses on adults aged 18 to 59 who have certain health conditions, putting them at higher risk from RSV. The second part includes adults aged 18 and older who have received a kidney, liver, or lung transplant. Participants will receive the vaccine, and researchers will monitor their health and immune response closely.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ModernaTX, Inc.

Enrolment target

1,153

Start

06 Oct 2023

Estimated completion

30 Jul 2026

Respiratory Syncytial Virus

What is this study about?

Respiratory Syncytial Virus, or RSV, is a common bug that usually causes cold-like symptoms. However, for some adults, especially those with ongoing health conditions or weakened immune systems, RSV can lead to more serious problems like pneumonia and breathing difficulties. This study is testing a new vaccine, called mRNA-1345, specifically designed to help protect these vulnerable adults from RSV.

The researchers want to understand two main things: first, how safe this new vaccine is, meaning how well people tolerate it and if there are any side effects. Second, they want to see how well the vaccine helps the body's natural defence system (the immune system) create protection against the RSV virus. If the vaccine works well, it could significantly reduce the number of people who get severely ill from RSV.

This research is in what's called 'Phase 3,' which means the vaccine has already been tested in smaller groups and shown some promise. Now, it's being tested in a larger group of people to gather more information before it could potentially be made widely available. The study includes two main groups of adults: those aged 18 to 59 who have specific health issues like heart or lung disease or diabetes, and adults aged 18 and over who have had an organ transplant. This is important because these are the groups who are often most affected by RSV.

Key takeaways

This study is testing a new RSV vaccine (mRNA-1345) in adults.
It aims to check the vaccine's safety and how well it boosts your immune system.
The study includes adults with certain health problems and organ transplant recipients.
Participation involves vaccine administration, clinic visits, and blood tests.
The vaccine is in Phase 3, a more advanced stage of testing.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers aged 18 and over, and there are specific requirements depending on which part of the study you might join. For one part, they're looking for adults aged 18 to 59 who can generally look after themselves and have specific health conditions, such as coronary heart disease, heart failure, type 1 or type 2 diabetes managed with medication, or long-term lung conditions like asthma or COPD. Your doctor would need to confirm these conditions.

The second part of the study is for adults aged 18 and over who have had a kidney, liver, or lung transplant at least six months ago and are taking medication to prevent their body from rejecting the new organ. Regardless of which group, you must be able to follow the study's instructions.

There are also reasons why you might not be able to join. For example, if you've recently taken part in another clinical trial where you received an experimental medicine, or if you've ever had a severe allergic reaction to a similar vaccine. If you have certain heart conditions like inflammation of the heart muscle (myocarditis), or if you've been on long-term immune-suppressing medicines recently, you might not be able to take part. The study team will review your medical history carefully to make sure it's safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or older?
Do you have a heart condition, long-term lung disease, or diabetes (if aged 18-59)?
Have you had a kidney, liver, or lung transplant at least 6 months ago (if 18+)?
Have you *not* participated in another experimental drug trial recently?
Have you *not* had any severe allergic reactions to previous vaccines or medications?
Do you *not* have a history of heart inflammation (myocarditis)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the mRNA-1345 vaccine. Throughout the study, the research team will closely monitor your health. This will involve several visits to the clinic where they will assess your general health, check for any side effects, and take blood samples. These blood samples help the researchers understand how your immune system is responding to the vaccine.

You'll also be asked to keep a record of your health and any symptoms you experience between visits. It's important to attend all scheduled appointments and follow the study instructions carefully. The total duration of your participation in the study will be explained by the research team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to the scientific understanding of a new vaccine that could help protect vulnerable adults from RSV. While this vaccine has shown promise in earlier stages, like all medicines, it may have side effects. These could be mild, like soreness at the injection site, or more serious, though serious side effects are thoroughly investigated. All possible risks will be fully explained before you agree to take part, and you will have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (44)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Lenzmeier Family Medicine - CCT - PPDS
Verified postcode
Glendale, United States
Foothills Research Center - CCT - PPDS
Verified postcode
Phoenix, United States
Fiel Family & Sports Medicine - PC - CCT - PPDS
Verified postcode
Tempe, United States
Baptist Health Center for Clinical Research
Verified postcode
Little Rock, United States
David Geffen School of Medicine at UCLA
Verified postcode
Los Angeles, United States
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
Verified postcode
San Diego, United States
Critical Care, Pulmonary and Sleep Associates / CCT Research
Verified postcode
Lakewood, United States
Yale University School of Medicine
Verified postcode
New Haven, United States
Excel Medical Clinical Trials DBA Flourish
Verified postcode
Boca Raton, United States
Indago Research and Health Center
Verified postcode
Hialeah, United States
CenExel RCA - Hollywood
Verified postcode
Hollywood, United States
Clinical Research Atlanta - Headlands - PPDS
Verified postcode
Stockbridge, United States

Common questions

What is RSV?

RSV is a common virus that usually causes mild cold-like symptoms, but it can be more serious for some adults, especially those with certain health conditions or weaker immune systems.

What is the mRNA-1345 vaccine?

It's a new vaccine being tested to see if it can help your body's immune system protect you from RSV.

Who is this study for?

This study is for adults generally aged 18 and over who are at higher risk from RSV due to certain health conditions or a history of organ transplant.

What will happen if I join?

You will receive the vaccine and have regular clinic visits, blood tests, and health checks to monitor your safety and immune response.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.