Immunogenecity and Safety of VaccinemRNA-1273 in Elderly Volunteers (Over 65 y) Compared to Young… (NCT04748471) | Clinical Trial Compass
UnknownPhase 2
Immunogenecity and Safety of VaccinemRNA-1273 in Elderly Volunteers (Over 65 y) Compared to Younger Ones (18-45y)
180 participantsStarted 2021-02-10
Plain-language summary
This study aims to evaluate the immunogenicity of Moderna mRNA-1273 vaccine in volunteers aged 65 years or more compared to volunteers aged 18-45 years, over 24 months duration. It will provide necessary data on the early immunological response to the vaccine and its evolution in quantitative and qualitative terms. This study will allow establishing how aging influences the response to the vaccine and help to adapt the vaccinal plan. For instance it will suggest the necessity of a vaccination booster.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 65 years old, at least 75 years old or 18 to 45 years old, depending on the group of inclusion.
✓. Healthy adults, or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
✓. Understands and agrees to comply with the study procedures (visits, phone calls) and provides written free informed consent.
✓. Able to comply with study procedures based on Investigator judgement.
✓. Affiliated to a social security system, (except state medical aid)
Exclusion criteria
✕. Subject is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 within the past 14 days at enrolment visit.
✕. History of documented COVID-19 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV-2+) prior to first vaccine administration
✕. Subjects with positive serology to SARS-CoV-2 at the enrolment visit
✕. Subjects who already received another anti-SARS-CoV-2-vaccine
✕. Subjects who received BCG given within the last year.
✕
What they're measuring
1
Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera
Timeframe: Day 57 (28 days after second injection of mRNA-1273)
. An immediate family member or household member of study staff.
✕. Use of immunosuppressive drugs like e.g. corticosteroids at a dosage \> 10mg/day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
✕. Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.