RecruitingPHASE1INTERVENTIONAL

A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults

This research study is looking at potential new vaccines, known as mRNA-1365 and mRNA-1345, designed to protect against two common viruses: Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV). These viruses can cause serious breathing problems, especially in older adults. The main goal of this study is to carefully check if these new vaccines are safe for older healthy adults. We also want to understand what kind of temporary reactions or side effects people might have after getting the vaccine. Finally, we'll be looking at how well the vaccines encourage the body's immune system to produce a protective response. This is a first-stage study, meaning it's one of the earliest steps in developing these vaccines.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

ModernaTX, Inc.

Enrolment target

375

Start

11 Aug 2026

Estimated completion

20 Jul 2027

Respiratory Syncytial Virus (RSV)Human Metapneuomovirus (hMPV)

What is this study about?

You might have heard of viruses like Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV). These can cause cold-like symptoms, but for older people, they can sometimes lead to more serious breathing problems, like pneumonia. This study is testing new ways to protect people from these viruses using a type of vaccine called an mRNA vaccine, similar to some COVID-19 vaccines.

The researchers are particularly interested in older adults because they are more vulnerable to severe illness from RSV and hMPV. The study has three main aims: first, to ensure the new vaccines (called mRNA-1365 and mRNA-1345) are safe; second, to understand any temporary side effects or reactions people might have after the vaccine; and third, to see how well the vaccines help the body's immune system create protection against these viruses. This is an important step in developing new ways to keep older adults healthy.

By taking part, you would be helping scientists learn more about these potential new vaccines. This information is crucial for deciding if these vaccines can move to larger studies and eventually become available to the public. Your participation would contribute significantly to medical research aimed at improving health and preventing serious illness in older age.

Key takeaways

This study is testing new mRNA vaccines for RSV and hMPV in older adults (60+).
It's a first-stage study focusing on vaccine safety and how the immune system reacts.
Participation involves receiving a vaccine and attending regular check-ups and blood tests.
You must be generally healthy or have well-controlled long-term conditions.
You cannot have participated in previous RSV/hMPV vaccine studies or had certain severe allergic reactions.
Your involvement helps advance medical research to protect older people from serious illnesses.

Who may be eligible?

To be considered for this study, you would need to be generally healthy. If you have a long-term health condition, it should be stable and well-managed. You'd also need to be aged 60 years or older. Researchers will check your overall health and medical history to make sure the study is a good fit for you.

There are certain reasons why someone might not be able to join. For example, if you've ever had a very serious allergic reaction (anaphylaxis) to any mRNA vaccine or its ingredients, you wouldn't be able to take part. Also, if you have certain immune system problems, an autoimmune condition, or if you've recently had an RSV or hMPV vaccine, this study might not be suitable for you. Doctors involved in the study will make the final decision based on a thorough review of your health.

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 60 years old or older?
Are you generally healthy, or are your ongoing health conditions stable and well-managed?
Have you ever had a serious allergic reaction (anaphylaxis) to an mRNA vaccine or its ingredients?
Do you have a history of serious immune system problems or an autoimmune condition?
Have you received a vaccine for RSV or hMPV in the past?

Answer every question to see your result.

What does participation involve?

This is a Phase 1 study, which means it's an early stage where a small group of people helps us learn about a new vaccine. If you join, you would receive one of the study vaccines. You would have several visits to the clinic so the study team can check your health, look for any side effects, and take blood samples. These blood samples help us understand how your immune system is reacting to the vaccine. There would also be follow-up calls or visits to track your progress over time. The total duration of your participation would be explained by the study team, but typically, these early-stage vaccine studies involve monitoring for several months.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. While there is no guarantee you will directly benefit, you would be contributing to valuable medical research that could help prevent serious illnesses in the future. Potential risks might include common vaccine side effects like soreness, redness, or swelling where you had the injection, or temporary flu-like symptoms. More serious reactions are rare but possible. All procedures will be explained in detail, and your safety will be monitored closely throughout the study. Remember, joining is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (10)

Diex Recherche Quebec
Verified postcode
Québec, Canada· Recruiting
Diex Recherche Victoraville
Verified postcode
Victoriaville, Canada· Recruiting
MAC Clinical Research
Verified postcode
Manchester, United Kingdom· Not yet recruiting
Southampton General Hospital, NHS
Verified postcode
Southampton, United Kingdom· Not yet recruiting
Norfolk and Norwich University Hospital, NHS
Verified postcode
Norwich, United Kingdom· Not yet recruiting
University Hospital Birmingham, NHS
Verified postcode
Birmingham, United Kingdom· Not yet recruiting
Royal Free Hospital, NHS
Verified postcode
London, United Kingdom· Not yet recruiting
Guys and St. Thomas Hospital, NHS
Verified postcode
London, United Kingdom· Not yet recruiting
St. George University Hospital, NHS
Verified postcode
London, United Kingdom· Not yet recruiting
Royal Victoria Infirmary, NHS
Verified postcode
Newcastle, United Kingdom· Not yet recruiting

Common questions

What are RSV and hMPV?

RSV (Respiratory Syncytial Virus) and hMPV (Human Metapneumovirus) are common viruses that can cause cold-like symptoms, but can lead to more serious breathing problems, especially in older adults.

What does 'mRNA' mean in the vaccine name?

mRNA stands for 'messenger RNA'. These vaccines teach your body's cells how to make a harmless piece of a virus protein, which then trains your immune system to recognise and fight off the real virus.

What is a Phase 1 study?

A Phase 1 study is the first step in testing a new treatment or vaccine in people. It mainly checks for safety, what dose might work best, and how the body reacts to it, usually involving a small number of participants.

Will I know which vaccine I receive?

In some studies, participants may not know which specific intervention they receive until later. The study team will explain how this works.

Will I get paid for taking part?

The study team can provide information on whether any compensation for time and travel expenses is offered for participating in this research.

How to find out more

Moderna WeCareTeam

wecareclinicaltrials@modernatx.com 1-866-663-3762 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.