COVID-19 vaccination
Conditions
Interventions
Intervention group (n=10): Participants will receive 20 µg of mRNA-1273 vaccine
through the intradermal route using a micro-needle delivery system.
Control group (n=10): Participants will receive 20
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: - SARS-CoV-2-spike protein-specific binding IgG antibody levels Safety: - Local reactions (pain at the injection site, redness, and swelling) - Reaction regional lymph nodes (pain, swelling) - Use of antipyretics and painkillers - Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| - SARS-CoV-2-spike protein-specific binding IgG and IgA antibody levels and RBD- specific binding IgG antibody levels in serum - SARS-CoV 2 WT neutralizing antibody levels Exploratory - Number of Spike-protein specific proliferating B-cells, plasma cells and B-memory cells - INF-gamma concentration and other cytokine responses after over-night incubation | — |
Countries
Netherlands
Outcome results
None listed