Status:
TERMINATED
Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly
Lead Sponsor:
Radboud University Medical Center
Conditions:
Vaccination; Infection
COVID-19
Eligibility:
All Genders
75+ years
Phase:
PHASE2
Brief Summary
Respiratory tract infections, e.g. caused by SARS-CoV-2, disproportionately affect elderly. Vaccination has shown to be the most cost-effective approach to prevent infections. However, older adults of...
Eligibility Criteria
Inclusion
- Male or female aged ≥75 years at the moment of immunization.
- Healthy, determined by medical history and clinical judgement 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 his/her general practitioner is informed about participation in the study.
- 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.
Exclusion
- Medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.
- No decision-making capacity.
- History of severe adverse reaction to a vaccine or to any component of the study intervention.
- Thrombose with thrombocytopenia syndrome after vaccination with a COVID-19 vaccine.
- Dermatological conditions that might interfere with the ID 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 IM injection.
- Participation in other studies involving other study interventions within 28 days prior and during 28 days after receiving the study intervention.
- Receipt of any other non-study vaccine within 28 days prior and after receiving the study intervention.
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05977127
Start Date
September 26 2023
End Date
March 21 2024
Last Update
March 28 2024
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands