A Phase 2b, randomized, placebo-controlled, observer-blind study in adults 60 years and older to evaluate the efficacy, safety, and immunogenicity of a bivalent protein vaccine candidate against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV) are common viruses that can cause serious chest infections, especially in older adults. Currently, there is a need for better combined protection against both illnesses. This study is testing an investigational two-in-one vaccine to see if it safely prevents chest and lung infections caused by RSV and HMPV. Participants will be randomly chosen to receive either the new vaccine or a harmless saltwater injection (placebo). Neither the participants nor the local study staff will know who receives which injection. Over the course of the study, researchers will track any cold or chest symptoms, test blood samples to check immune responses, and monitor any side effects. The results will help doctors understand whether this combined vaccine can offer effective winter protection for older people.
At a glance
What is this study about?
Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV) are common viruses that affect the breathing passages and lungs. While they often cause mild cold-like symptoms in healthy younger people, they can lead to severe chest infections, such as bronchitis or pneumonia, in older adults. Every winter, these illnesses put significant pressure on the NHS and can lead to hospital stays for vulnerable individuals.
This clinical study is evaluating a new experimental vaccine that aims to protect against both RSV and HMPV in a single jab. By combining defences against two major respiratory viruses, researchers hope to create a simpler, more efficient way to protect older adults before the winter season begins.
The trial is looking closely at how well the vaccine works compared to a placebo (a dummy injection of standard salt water). Scientists will track whether participants who get the vaccine experience fewer chest infections than those who receive the placebo. They will also look at blood samples to measure antibodies, which are proteins the body makes to fight off infections.
Safety is a central focus of this research. The study team will closely monitor participants for any unwanted reactions, from mild soreness around the injection site to more noticeable flu-like symptoms, ensuring the vaccine meets high safety standards.
Key takeaways
- The trial tests a combined jab targeting two common chest viruses: RSV and HMPV.
- The study primarily focuses on adults aged 60 and older.
- Participants will receive either the trial vaccine or a dummy saltwater injection.
- Safety, side effects, and immune responses will be closely tracked over several months.
- Taking part is voluntary, and you can withdraw at any point without affecting your NHS care.
Who may be eligible?
This study is aimed at adults, with a particular focus on those aged 60 and older who may benefit most from protection against respiratory viruses. Both men and women can take part.
To be eligible, you generally need to be in good health or have stable, well-managed long-term medical conditions. The study team will want to ensure taking part is safe for you based on your overall medical history.
You may not be able to join if you have certain active immune system disorders, have recently had specific vaccines, or are taking medications that significantly weaken your immune system. The trial staff will go through your complete health record to check if the trial is right 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.
- I am an adult aged 60 or older (or meet specific trial age criteria).
- I am in generally good health, or my current health conditions are stable.
- I am willing to attend scheduled clinic visits and have blood tests.
- I am able to keep a diary of my symptoms and report any winter colds or coughs.
- I do not have a known severe allergy to vaccine components.
What does participation involve?
If you decide to take part, your participation will usually last for around one year to cover the peak winter virus season. You will start with a screening appointment where the study team will explain everything, answer your questions, and check your health.
You will receive a single injection in your upper arm. Half of the participants will receive the trial vaccine, and the other half will receive a dummy saltwater injection. You will be asked to track how you feel in a symptom diary for the first week or two, noting any soreness, tiredness, or fever. Throughout the study, you will attend a few clinic visits for health checks and blood tests to see how your immune system is responding. If you develop any cold, cough, or chest symptoms at any point, you will contact the study team so they can test you for respiratory viruses.
Potential risks and benefits
Locations (7)
- —UnverifiedEstonia
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedFinland
- —UnverifiedNetherlands
Common questions
What is HMPV?
Human Metapneumovirus (HMPV) is a common respiratory virus that causes symptoms similar to a cold, flu, or RSV, but it can lead to more serious chest infections in older adults.
Can I choose to get the vaccine instead of the placebo?
No. A computer randomly decides who gets the real vaccine and who gets the dummy injection. This ensures the study results are fair and unbiased.
Does it cost anything to take part?
No, taking part is free. The study covers all trial-related appointments, tests, and injections. Reasonable travel expenses to the clinic are usually reimbursed.
What should I do if I get a cough or cold during the study?
You should let the study team know right away. They will arrange a gentle swab test to find out if your illness is caused by RSV, HMPV, or another virus.
Can I still have my regular NHS flu or COVID-19 jabs?
Usually yes, but the study team may ask you to leave a short time gap between your trial injection and your routine seasonal vaccines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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