Respiratory tract infections, e.g. caused by SARS-CoV-2, disproportionately affectelderly. Vaccination has shown to be the most cost-effective approach to preventinfections. However, older adults often fail to induce a potent immune response tovaccines, as was also seen recently for COVID-19 mRNA vaccines. This is likely due toimmune dysfunction as a consequence of aging. To potentiate a stronger immune response,vaccine administration into the papillary dermis (intradermal, ID) has been proposed asan alternative strategy to intramuscular (IM) administration.Vaccination through the ID route has shown to be safe and equally or more effective thanIM vaccination with a wide variety of vaccines. Recently, ID administration has beentested with two COVID-19 mRNA vaccines (Spikevax, Moderna and Comirnaty, Pfizer/BioNTech)in reduced (fractional) doses of the standard IM dose.To ease ID administration and thereby facilitate the implementation of this route,silicon-based microneedles have been developed. These needles have shown to allow IDadministration of the Spikevax vaccine with equal safety and immunogenicity profiles asthe traditional Mantoux approach in young adults.In the present study, we will investigate the immunogenicity of a 20 mcg dose of theCOVID-19 mRNA Comirnaty vaccine through ID administration with silicon microneedles inelderly people (75 years and older), and compare this to immunogenicity of IMadministration of a 20 mcg dose and a 30 mcg (standard IM) dose.
Not Provided
Biological: Comirnaty
Administration of Comirnaty vaccine
Inclusion Criteria:
- 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 Criteria:
- 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.
Radboudumc
Nijmegen 2750053, Netherlands
Hans de Graaf, Principal Investigator
Stichting Radboud University Medical Center