Combining the shingles vaccine with the COVID-19 booster or flu vaccine (ZosterFluCOV)
study.
What is the purpose of this research study?
We want to know whether receiving a shingles vaccine at the same time as either a flu or COVID-19 vaccine is safe and works as well compared to when the shingles vaccine is given alone. In the UK, a shingles vaccine is offered to people when they reach 70. Flu and COVID-19 vaccines are also offered to people in this age group. If we could give the shingles vaccine at the same time as either the flu or COVID-19 vaccine it may make it easier for people, and for GPs, as fewer appointments would be needed.
Am I suitable to take part?
We are looking for volunteers aged 50 years and over. We welcome volunteers from all communities and those with health conditions who would usually be offered the flu vaccine. In order to take part in the study you must not have received a shingles vaccine within 5 years of your enrolment in the study. It is also important that you have received your initial COVID-19 vaccinations (usually two doses).
If you have recently had a COVID-19 or flu vaccine you can still take part in the study but there will need to have been a gap of at least 90 days between you receiving these vaccines and volunteering to take part.
There may be some people who are not eligible to take part. This will be determined from your answers to the questions in an online screening questionnaire and a discussion with the local research team.
What vaccines are being used in this study?
There are 3 vaccines that are being used in this study; shingles vaccine, flu vaccine and the COVID-19 vaccine.
Shingles vaccine
The shingles vaccine being used in this study is the recombinant subunit herpes zoster vaccine (Shingrix, GSK).
It is a non-live vaccine that provides immunity against shingles. The vaccine contains anadjuvant that is used to enhance the body’s immune response to the vaccine. This is particularly important as we get older, as our immune responses to both natural infection and vaccines weaken.
Flu vaccine
The study will be using the flu vaccine for 2024/25, Adjuvanted quadrivalent influenza vaccine (Fluad), containing the adjuvant MF59 (aQIV).
This vaccine contains four inactivated (non-live) strains of the flu virus that cause infection over the winter. In addition to the inactivated parts of the flu virus, this vaccine also contains, an adjuvant (MF59) which will help to boost the immune system response to the vaccine.
COVID-19 vaccine
You will receive the Comirnaty® XBB.1.5 or JN.1 COVID-19 mRNA vaccine as part of this study. These are the vaccines used for the national vaccination programme in 2024.
Saline injection (placebo)
It is possible that at vaccination study visits 1 and 3 that one or more of the vaccines you receive will be a placebo (saline) injection. The placebo injection will look just like the other vaccines but just contains sodium chloride, which is sterile, salty water, typically used to dilute other vaccines.
What are the side effects of the shingles, COVID-19 and flu vaccines?
People very often have tenderness, pain, warmth, redness, itching, swelling or bruising or less commonly have a small lump in their arm where they have been vaccinated.
After vaccination it is common to experience the following side effects for all vaccines. These side effects are reported to be severe enough to interfere with activities of daily living in up to 10% who have received the shingles vaccine in previous trials. The most common sides effects are tiredness (fatigue) and muscle ache. They usually last for less than a week (more commonly 24-48 hours after vaccination).
- Fatigue (tiredness)
- Joint aches
- Headaches
- Muscle aches
- Feeling sick or nauseated, vomiting or diarrhoea
- Flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
- Feeling unwell (malaise)
Other less common side effects are:
- Abdominal pain
- Decreased appetite
- Feeling dizzy
- Swollen lymph nodes (glands)
- Excessive sweating, itching skin or rash
If you do experience any side effects then taking paracetamol may help.
Rare side effects
Vaccines may cause serious but rare side effects these include the following:
Severe Allergic Reactions
With any vaccination there is a small risk of rare serious adverse events, such as an allergic reaction. Mild to severe allergic reactions can occur in response to any part of a vaccine or medicine. Severe allergic reactions (anaphylaxis) can be fatal but are extremely rare (about 1 in a million vaccine doses).
In case of this unlikely event, medication for treating allergic reactions is available and the researchers are appropriately trained in the management of anaphylaxis.
Heart inflammation (myocarditis or pericarditis) has been reported following administration of the COVID-19 vaccine. Symptoms include chest pain and shortness of breath which occur a few days after vaccination. Most people have had mild symptoms with no evidence of long term problems so far.
Guillain-Barré Syndrome (GBS) affects the nervous system . GBS is an illness in which people can develop severe weakness and be fatal. Following immunisation with the flu vaccine GBS has been reported very rarely.
If you experience unexpected events or become in any way concerned you will be provided
with a 24hr contact number to call one of the study doctors at any time.
What are the advantages of taking part?
The information gained from the study will help us to determine whether it is safe and effective to give the shingles vaccine at the same time as the flu vaccine or the COVID-19 vaccine.
Are there any risks from taking part in the study?
In addition to the side effects detailed above drawing blood may cause discomfort and occasionally bruising at the site where the needle enters. Light headedness and fainting can also occur when having blood taken, though this is less frequent. We will need to take approximately 50mL of blood at the first study visit and 40ml at each subsequent study visit (approximately 8 teaspoons). The total amount we will take over the period of the study will be approximately 250ml. This is well below the recommended limit of 470mL every 3 – 4 months for blood donations to the National Blood Transfusion Service.
What will happen if I don’t want to carry on with the study?
You are free to stop taking part in the study at any time, without giving a reason. Withdrawing from the study will not affect your routine medical care or rights. Unless you state otherwise, any blood samples taken whilst you have been in the study will continue to be stored and used for research as detailed above. You are free to request that your samples are destroyed at any time during the study. Your data would be managed as laid out in the section ‘What will happen to my data’. If you choose to withdraw from the study, your standard medical care will not be affected.
What’s next?
If you are interested in taking part in this study, please click on the following link to find a study site.