COVID-19
Conditions
Interventions
intradermal injection of a fractional dose (10 µg and 20 µg) mRNA-1273 LPN vaccine compared to intramuscular injection of the standard dose (100 µg) mRNA-1273 LPN vaccine
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Kinetics of SARS-CoV 2 WT neutralizing antibody (seroconversion, GMT and GM fold rise) and of SARS-CoV-2-spike protein-specific binding IgG antibody levels and RBD- specific binding IgG antibody levels (seroconversion, GMC and GM fold rise) over time - Positive SARS-CoV-2 PCR (with or without clinical symptoms) of nasopharyngeal/throat swab - Seroconversion SARS-CoV-2 (Nucleocapsid Serology) - Proportion of afucosylated IgG variants - SARS-CoV-2 WT neutralizing antibodies in nasal fluid - SARS-CoV-2-spike protein–specific binding IgG and IGA antibody levels and RBD- specific binding IgG and IGA antibody levels in nasal fluid - Parameters quantifying germinal center activity - Whole blood interferon-gamma release assay to SARS-CoV-2 antigen | — |
Contacts
Public ContactAnna Roukens
Leiden University Medical Center
Outcome results
None listed