All studies
Active not recruitingPHASE3INTERVENTIONAL

Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

This study is testing a new vaccine for Respiratory Syncytial Virus (RSV) in people aged 60 and over. RSV is a common germ that can cause cold-like symptoms, but it can be more serious for older adults, sometimes leading to chest infections. Researchers want to find out if this new vaccine is safe, how many side effects it causes, and how well it helps your body create protection (immunity) against RSV. They will also look at how long this protection lasts, up to five years, after just one dose. In some parts of the study, they will also check if giving extra doses helps, and how often these doses should be given.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
1,720
Start
15 Feb 2021
Estimated completion
19 Feb 2027

Results

Results from this study

Posted December 2023

Results have been published for this study.

Primary outcome
Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Full results on the registry

What is this study about?

RSV stands for Respiratory Syncytial Virus. It's a very common germ that usually causes mild, cold-like symptoms. However, for some people, especially older adults and very young babies, it can lead to more serious problems like bronchitis (inflammation of the airways) or pneumonia (a lung infection). Because older adults can get very sick from RSV, scientists are working on vaccines to help protect them.

This particular study is focusing on a new vaccine designed to prevent RSV infections in people aged 60 and over. The main goals are to understand how safe the vaccine is, if it causes any side effects (like feeling a bit unwell or having a sore arm), and how well it helps your immune system (your body's defence system) produce protective antibodies against the virus. They are also keen to see how long this protection lasts after one dose, checking up to five years later.

Another important part of the study is to explore if giving extra doses of the vaccine at different times could improve protection or make it last even longer. By doing this research, scientists hope to develop an effective vaccine that can reduce the risk of serious RSV infections for older people and keep them healthier.

Key takeaways

  • The study is testing a new RSV vaccine for people aged 60+.
  • It aims to check the vaccine's safety and effectiveness.
  • Researchers will monitor how long the vaccine's protection lasts (up to 5 years).
  • All participants will receive the active vaccine.
  • Participation involves regular follow-up visits and blood tests.

Who may be eligible?

To join this study, you must be 60 years old or older when you get your first vaccine shot. You can live on your own in the community or in a care home. It's important that you are generally well enough to take part and can follow the study instructions, as decided by the doctor running the study. If you have longstanding health conditions like diabetes, high blood pressure, or heart disease, you can still participate as long as these conditions are stable and well-managed.

However, there are some reasons why you couldn't join. For example, if you have a condition that weakens your immune system, or if you're taking medicines that suppress your immune system. You also can't take part if you've had a bad allergic reaction to vaccines in the past, have a severe ongoing illness, recurrent seizures, or any condition that significantly affects your memory or understanding.

Also, if you've been in another medical study or taken any experimental (non-approved) medicines or products within the last 30 days, or plan to do so during this study, you wouldn't be able to join. The study team needs to make sure it's safe for you to get the injection and that you can complete all the required visits and tests.

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.

  1. Am I 60 years old or older?
  2. Do I generally feel well and able to follow instructions?
  3. Do I have any conditions that weaken my immune system?
  4. Have I had severe allergic reactions to vaccines before?
  5. Am I currently in another medical study or taking experimental medicines?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive one injection of the study vaccine. You'll then have several follow-up visits over a period of up to five years. During these visits, the study team will check your health, ask about any side effects you might have had, and take blood samples. The blood samples help them see how your body is responding to the vaccine and how long the protection lasts. You might also be asked to keep a simple diary to record any symptoms or side effects. The exact number of visits and the full duration will be explained to you in detail by the study team, but it could involve regular contact over five years.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like receiving a new vaccine that could protect you from RSV. However, there's no guarantee the vaccine will work, and you might experience side effects, which are usually mild like a sore arm or feeling a bit unwell, but could be more serious in very rare cases. All known risks will be fully explained before you agree to participate. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (45)

  • GSK Investigational Site
    Verified postcode
    Mobile, United States
  • GSK Investigational Site
    Verified postcode
    Phoenix, United States
  • GSK Investigational Site
    Verified postcode
    Riverside, United States
  • GSK Investigational Site
    Verified postcode
    San Diego, United States
  • GSK Investigational Site
    Verified postcode
    Coral Gables, United States
  • GSK Investigational Site
    Verified postcode
    Fort Myers, United States
  • GSK Investigational Site
    Verified postcode
    Sarasota, United States
  • GSK Investigational Site
    Verified postcode
    The Villages, United States
  • GSK Investigational Site
    Verified postcode
    Evansville, United States
  • GSK Investigational Site
    Verified postcode
    Wichita, United States
  • GSK Investigational Site
    Verified postcode
    Richfield, United States
  • GSK Investigational Site
    Verified postcode
    Kansas City, United States

Common questions

What is RSV?

RSV is a common virus that can cause cold-like symptoms, but it can be more serious for older adults, leading to chest infections.

Who is this vaccine for?

This vaccine is being tested specifically for adults aged 60 and over to help protect them from RSV infections.

How long will the study last?

The study will follow participants for up to five years after they receive the vaccine to see how long the protection lasts.

Will I get the actual vaccine?

Yes, all participants in this study will receive the investigational RSV vaccine, not a placebo (dummy treatment).

What kind of side effects might I experience?

Common side effects from vaccines usually include a sore arm, redness or swelling where you got the shot, or feeling tired, headache, or muscle aches.

How to find out more

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

Discussion

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