COVID-19 trials registries data warehouse

https://trialregister.nl/trial/9275

Anna Roukens

a.h.e.roukens@lumc.nl

2021-02-16

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Prevention

- Male or female participants between the ages of 18 and 30 years, inclusive at randomization.- 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 hospitalization 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.- 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.- Females only: female volunteers of childbearing potential (i.e. have a uterus and are neither surgically sterilized nor postmenopausal) must not be pregnant or breastfeeding. They should agree to use adequate contraception at least up to four weeks following the final dose of mRNA-1273 vaccine

- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior 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 (eg, anaphylaxis) to any component of the study intervention(s).- Receipt of medications intended to prevent COVID-19.- Previous clinical or microbiological diagnosis of COVID-19.- Individuals at high risk for severe COVID-19, 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 a history of autoimmune disease or 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 the final injection.- Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.- SARS-CoV-2 PCR-positive nasopharyngeal/throat swab at the screening before receipt of first 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 first study dose.- Anticipated receipt of any other non-study vaccine within 28 days, after last study dose administration

2

Leiden University Medical Center

18

30

Netherlands

Healthy volunteers

N/A

150

- Nature; frequency and severity of local reactions. Solicited adverse events include: pain; redness and swelling at the injection site and pain and swelling at the regional lymph nodes- Nature; frequency and severity of systemic events. Solicited adverse events include: fever; fatigue; headache; chills; vomiting; diarrhea; new or worsened muscle pain; and new or worsened joint pain.- Use of antipyretics and painkillers- SARS-CoV-2 WT neutralizing antibody titers rate on Day 43- SARS-CoV-2-spike protein–specific binding IgG level on D 43

Phase 1/Phase 2

[{"arm_notes": "10 \u03bcg or 20 \u03bcg; 2;Day0-28", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20 \u03bcg or 100 \u03bcg; 2;Day0-28", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]