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Intradermal administration of a COVID-19 mRNA vaccine in elderly
EU CTIS ID: 2023-503800-99-00
What this study is testing
In the present study, we will investigate the immunogenicity of a 20 mcg dose of the COVID-19 mRNA Comirnaty vaccine through intradermal administration with silicon microneedles in elderly people (75 years and older), and compare these to the immunogenicity of intramuscular administration of a 20 mcg dose and a 30 mcg dose (30 mcg is the standard intramuscular dose).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female aged ≥75 years at the moment of immunization.
- Agrees to provide access to information regarding their vaccination background.
- Agrees that the study physician and his/her delegates have access to their medical file at Radboudumc.
- Healthy, determined by medical history and clinical judgment of the investigator. Participants with a pre-existing illness that is stable, defined as disease not requiring significant change in therapy or hospitalisation during the 6 weeks before enrolment and not expected to require any intervention during the study, can be included.
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- Willing to postpone their regular COVID-19 vaccination upon invitation by the Municipal Health Service or general practitioner until at least four months after receiving the intervention.
You likely can't join if
- Medical or psychiatric condition that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Participation in other studies involving other study interventions within 28 days prior and during 28 days after receiving the study intervention.
- Thrombose with thrombocytopenia syndrome after vaccination with a COVID-19 vaccine
- Receipt of any other non-study vaccine within 7 days prior and after receiving the study intervention.
- No decision-making capacity.
- History of severe adverse reaction to a vaccine or to any component of the study intervention.
See the full eligibility criteria
- Male or female aged ≥75 years at the moment of immunization.
- Agrees to provide access to information regarding their vaccination background.
- Agrees that the study physician and his/her delegates have access to their medical file at Radboudumc.
- Healthy, determined by medical history and clinical judgment of the investigator. Participants with a pre-existing illness that is stable, defined as disease not requiring significant change in therapy or hospitalisation during the 6 weeks before enrolment and not expected to require any intervention during the study, can be included.
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- Willing to postpone their regular COVID-19 vaccination upon invitation by the Municipal Health Service or general practitioner until at least four months after receiving the intervention.
- Completed a primary series of COVID-19 vaccination.
- Capable and willing to give personal signed informed consent.
- Adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Fully conversant in the Dutch language.
- Agrees that their general practitioner is informed about participation in the study.
- Medical or psychiatric condition that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Participation in other studies involving other study interventions within 28 days prior and during 28 days after receiving the study intervention.
- Thrombose with thrombocytopenia syndrome after vaccination with a COVID-19 vaccine
- Receipt of any other non-study vaccine within 7 days prior and after receiving the study intervention.
- No decision-making capacity.
- History of severe adverse reaction to a vaccine or to any component of the study intervention.
- Dermatological conditions that might interfere with the intradermal vaccination.
- Receipt of COVID-19 vaccination within 3 months before receiving the study intervention.
- Known or suspected immunodeficiency, as determined by medical history or medication use (inhalation corticosteroids are allowed).
- History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.