Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers
- Conditions
- COVID-19 vaccination10047438
- Registration Number
- NL-OMON51606
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- Male or female participants between the ages of 18 and 50 years, inclusive at
randomisation.
- Previously vaccinated with Comirnaty (Pfizer) or Spikevax (Moderna) at least
3 months before inclusion.
- Healthy participants who are determined by medical history and clinical
judgment of the investigator to be eligible for inclusion in the study. Healthy
participants with preexisting stable disease, defined as disease not requiring
significant change in therapy or hospitalisation for worsening disease during
the 6 weeks before enrolment, can be included.
- Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures.
- Participants are willing to postpone their regular COVID-19 revaccination
upon invitation by the municipal health center or general practitioner until
four weeks after receiving the intervention (after the last sampling of
D29+/-1).
- Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol.
- Other medical or psychiatric condition including recent (within the past
year) or active suicidal ideation/behaviour or laboratory abnormality that may
increase the risk of study participation or, in the investigator*s judgment,
make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (e.g., anaphylaxis) to any component of the study
intervention(s).
- Receipt of medications intended to prevent COVID-19.
- Previous microbiological diagnosis of COVID-19 less than 3 months ago.
- Previous COVID-19 (re)vaccination other than Comirnaty (Pfizer) or Spikevax
(Moderna) less than 3 months ago
- Individuals at high risk for severe COVID-19 (e.g. BMI > 40, diabetes, heart-
end/or lung disease), who are planned to receive COVID vaccine within the next
two months.
- Immunosuppressed individuals with known or suspected immunodeficiency, as
determined by history.
- Individuals with an active autoimmune disease requiring therapeutic
intervention.
- Receipt of systemic or topical corticosteroids.
- Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection.
- Women who are pregnant or breastfeeding.
- Planned pregnancy within four weeks after injection.
- Positive serological test for SARS-CoV-2 anti-N IgM and/or IgG antibodies at
screening visit.
- SARS-CoV-2 PCR-positive mid-turbinate/throat swab at the screening before
receipt of the vaccine dose.
- Participation in other studies involving study intervention within 28 days
prior to study entry and/or during study participation.
- Receipt of any other non-study vaccine within 28 days, before receipt of the
study dose.
- Anticipated receipt of any other non-study vaccine within 28 days, after the
study dose administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Immunogenicity:<br /><br>- SARS-CoV-2-spike protein-specific binding IgG antibody levels<br /><br><br /><br>Safety:<br /><br>- Local reactions (pain at the injection site, redness, and swelling)<br /><br>- Reaction regional lymph nodes (pain, swelling)<br /><br>- Use of antipyretics and painkillers<br /><br>- Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or<br /><br>worsened muscle pain, and new or worsened joint pain)<br /><br>- AEs<br /><br>- SAEs</p><br>
- Secondary Outcome Measures
Name Time Method <p>- SARS-CoV-2-spike protein-specific binding IgG and IgA antibody levels and<br /><br>RBD- specific binding IgG antibody levels in serum<br /><br>- SARS-CoV 2 WT neutralizing antibody levels<br /><br><br /><br>Exploratory<br /><br>- Number of Spike-protein specific proliferating B-cells, plasma cells and<br /><br>B-memory cells<br /><br>- INF-gamma concentration and other cytokine responses after over-night<br /><br>incubation</p><br>