Stichting Radboud University Medical Center
Nijmegen, The Netherlands
Not recruiting
Study on Intradermal COVID-19 mRNA Vaccine (Tozinameran, Famtozinameran) for Elderly Patients Aged 75 and Older
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a COVID-19 mRNA vaccine called Comirnaty Original/Omicron BA.4-5 in people aged 75 years and older. The vaccine is designed to help the body build protection against the virus that causes COVID-19. The study will compare two different ways of giving the vaccine: one is through a small injection into the skin using tiny needles, and the other is the usual method of injection into the muscle. The study will also compare two different doses of the vaccine: a 20 microgram dose and the standard 30 microgram dose.
The purpose of the study is to see how well the vaccine works when given in these different ways and doses. Participants will receive the vaccine and then have their blood tested to measure the levels of antibodies, which are proteins the body makes to fight infections. These tests will be done 28 days after vaccination to see how the body responds. The study will also look at any side effects that participants might experience after getting the vaccine, such as reactions at the injection site or other symptoms.
This study is important for understanding how to best protect older adults from COVID-19, especially since they are at higher risk for severe illness. By comparing different methods and doses of vaccination, researchers hope to find the most effective way to boost immunity in this age group. Participants will be monitored closely throughout the study to ensure their safety and to gather valuable information about the vaccine's effects.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Must be a male or female aged 75 years or older at the time of vaccination.
- Must agree to provide access to their vaccination history.
- Must agree that the study doctor and their team can access their medical records.
- Must be healthy as determined by medical history and the doctor's judgment. If there is a pre-existing illness, it must be stable, meaning it hasn't required significant changes in treatment or hospitalization in the last 6 weeks and isn't expected to need any intervention during the study.
- Must be willing and able to attend all scheduled visits, follow the vaccination plan, and complete laboratory tests and other study procedures.
- Must be willing to delay their regular COVID-19 vaccination until at least four months after receiving the study vaccine.
- Must have completed the initial series of COVID-19 vaccinations.
- Must be capable and willing to provide personal signed consent to participate in the study.
- Must have a good understanding of the study procedures and agree to follow them closely.
- Must be fluent in the Dutch language.
- Must agree that their general practitioner is informed about their participation in the study.
Who cannot join the trial?
3 criteria
- Participants must be **75 years or older**.
- Participants must be **healthy** or have a **stable disease**. This means their health condition is not changing or getting worse.
- Participants must not be part of a **vulnerable population**. This refers to groups of people who might be at higher risk of harm or exploitation.
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Investigated drugs
Comirnaty is a COVID-19 mRNA vaccine used to help protect people from getting sick with COVID-19. In this clinical trial, the vaccine is being given to elderly people, who are 75 years and older, to see how well it works when injected into the skin using tiny silicon needles. The study is comparing this method to the usual way of giving the vaccine, which is by injecting it into the muscle. The goal is to see if the skin injection can provide a similar or better immune response compared to the muscle injection.
What is already known about the treatment
Comirnaty – Comirnaty is a COVID-19 mRNA vaccine administered through intradermal injection using silicon microneedles, specifically in elderly individuals aged 75 and older. This vaccine is currently being studied to assess its ability to trigger an immune response when given in a 20 microgram dose compared to the standard 30 microgram dose administered intramuscularly. The main purpose of this vaccine is to protect against COVID-19 by teaching the body's immune system to recognize and fight the virus. It works by using a small piece of the virus's genetic material to instruct cells to produce a harmless protein, which then stimulates an immune response. Comirnaty is classified as an mRNA vaccine, a type of vaccine that uses messenger RNA to provide immunity.
Investigated diseases
COVID-19 – COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can start with mild symptoms such as fever, cough, and fatigue, but may progress to more severe respiratory issues. In some cases, it can lead to pneumonia, acute respiratory distress syndrome, and other complications. The progression of the disease varies widely among individuals, with some experiencing mild symptoms and others developing severe illness. The immune response to the virus plays a crucial role in the progression and severity of the disease.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2023-503800-99-00Estimated enrolment120 patientsSponsorStichting Radboud universitair medisch centrum
sourced from the EU Clinical Trials Register and site verification
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