COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05315362

Anna H Roukens, MD PhD

a.h.e.roukens@lumc.nl

2022-04-07

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: previously vaccinated with comirnaty (pfizer) and/or previously contracted covid-19 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). capable of giving personal signed informed consent as described in appendix 1, 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. previous covid-19 vaccination other than comirnaty (pfizer) 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.

2

Leiden University Medical Center

18

40

Netherlands

Healthy volunteers

N/A

20

adverse events;SARS-CoV-2-spike protein-specific binding IgG antibody levels

None

Phase 2

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