Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Intradermal administration of a COVID-19 mRNA vaccine in elderly

This study is investigating a different way to give COVID-19 mRNA vaccines, specifically for people aged 75 and older. Instead of the usual jab into the muscle, this study will give a small amount of the vaccine just under the skin. The vaccine used will be a special one that targets both the original COVID-19 virus and the Omicron BA.4-5 variant. Researchers want to find out if this method is good at making the body produce protective antibodies against the virus. They will measure these protective antibodies 28 days after vaccination. They will also keep a close eye on any side effects people might have, both common and unexpected, to make sure it's safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Stichting Radboud University Medical Center

Enrolment target

120

Start

26 Jul 2023

Adult volunteers (M/F) aged ≥75 years who are healthy or have stable disease

What is this study about?

This research study is looking into a new way to give COVID-19 mRNA vaccines to older adults, specifically those aged 75 and over. You might be familiar with mRNA vaccines like the ones already available, which are usually given into the muscle. This study is exploring a different method called 'intradermal administration', where a smaller amount of vaccine is given directly into the top layer of the skin, rather than deeper into the muscle.

Researchers are using a specific COVID-19 mRNA vaccine that's designed to protect against both the original COVID-19 virus and the newer Omicron BA.4-5 variant. The main goal is to see how well this new way of giving the vaccine helps the body create protective antibodies against COVID-19. They will measure these antibody levels in participants' blood 28 days after they receive the vaccine. If this method works well, it could potentially offer another way to vaccinate older adults.

The study will also carefully check for any side effects. This includes looking at common reactions around the injection site, like redness or swelling, and any body-wide reactions like feeling tired or having a headache. They'll also monitor for any more serious reactions. By doing this, they can understand both how effective this new approach is at boosting immunity and how safe it is for people in this age group.

Key takeaways

Study is for people aged 75 and over.
Investigating a new way to give COVID-19 mRNA vaccines (into the skin).
Uses a vaccine targeting original COVID-19 and Omicron BA.4-5.
Main goal: measure protective antibody levels.
Also carefully monitoring for any side effects.
Participation involves vaccine, blood tests, and health monitoring.

Who may be eligible?

This study is looking for volunteers who are 75 years old or older. Both men and women are welcome to take part. You can be generally healthy, or you can have existing health conditions as long as they are stable and well-managed.

The study team will review your medical history to make sure taking part is safe for you. They will confirm that any health conditions you have are stable and wouldn't be made worse by receiving the vaccine or participating in the study.

Unfortunately, if you are under 75, or if you have certain unstable health conditions, this particular study might not be suitable 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 75 years of age or older?
Are you generally healthy, or do you have stable, well-managed health conditions?
Are you able to attend study visits and provide blood samples?
Are you interested in receiving a COVID-19 mRNA vaccine as part of a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a single dose of the COVID-19 mRNA vaccine directly into your skin. You'll have a number of visits with the study team. They will take blood samples at specific times to measure your antibody levels, particularly 28 days after your vaccination. You will also be asked to keep track of any side effects you experience after the vaccination for a short period, and the study team will follow up with you to check on your well-being. The total duration of your participation in the study is not exactly specified here, but typically these kinds of trials involve follow-up over several weeks or months.

Potential risks and benefits

Taking part in a clinical trial means contributing to medical knowledge that could benefit many people. For you, there's a potential benefit of receiving a vaccine that aims to protect against COVID-19. However, as with any vaccine, there's a chance of experiencing side effects, which are usually mild and temporary, like soreness at the injection site, but rarely could be more serious. The research team will monitor you closely for any reactions. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What kind of vaccine is being tested?

It's an mRNA COVID-19 vaccine designed to protect against the original virus and the Omicron BA.4-5 variant, but given in a different way.

Who can take part?

Adults aged 75 and over, both men and women, who are healthy or have stable health conditions.

What is 'intradermal administration'?

It means the vaccine will be given with a small jab just into the top layer of your skin, not into the deeper muscle.

What will researchers be looking for?

They'll be checking how well your body makes protective antibodies against COVID-19 after getting the vaccine, and also monitoring for any side effects.

Will I have to pay to join?

No, clinical trials do not typically charge participants. Any study-related medical care or vaccine will be provided by the study.