Immunogenecity and Safety of VaccinemRNA-1273 in Elderly Volunteers (Over 65 y) Compared to Younger Ones (18-45y)
CoviCompareM
A Phase II Trial Assessing Immunogenicity and Safety of SARS-CoV-2 Vaccine mRNA-1273 in Volunteers Aged of 65 Years or More Compared to Participants 18-45 Years Old
2 other identifiers
interventional
180
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2023
CompletedFebruary 10, 2021
January 1, 2021
5 months
January 24, 2021
February 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera
Anti-SARS-CoV-2 Spike specific IgG Immunity acquisition
Day 57 (28 days after second injection of mRNA-1273)
Secondary Outcomes (10)
Anti SARS-CoV -2 IgG, IgA and IgM (total and subclasses IgG1-4) as measured by ELISA.
From Day 1 to Month 24
Anti-SARS-CoV-2 neutralizing antibody (in vitro neutralisation assay.
From Day 1 to Month 24
Anti-SARS-CoV-2 -specific neutralizing antibody (Pseudo neutralisation assay using lentiviral phenotypes carrying specific SARS-Cov-2 proteins.
From Day 1 to Month 24
Fluorospot assays (TH1, TH2, TH17, Cytotoxicity). Phenotyping of antigen specific T-Cells via Mass cytometry, B cell repertoire and memory
From Day 1 to Month 24
Mucosal SARS-CoV-2 -specific antibody via measure of sIgA, sIgM and IgG in saliva by specific home-made and commercially available ELISA assays.
From Day 1 to Month 24
- +5 more secondary outcomes
Study Arms (3)
18-45 years old
EXPERIMENTAL18 - 45 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
65-74 years old
EXPERIMENTAL65 - 74 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
At least 75 years old
EXPERIMENTALAt least 75 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
- 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.
- Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection.
- History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rush, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2-vaccine.
- History of severe allergic event
- Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4 weeks before the enrolment visits or planned before the study completion.
- Known HIV, active HCV or HBV infection
- Any pathological condition, such as cancer, which may be susceptible of reducing immunity response
- Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odile LAUNAY, Professor
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2021
First Posted
February 10, 2021
Study Start
February 10, 2021
Primary Completion
July 1, 2021
Study Completion
January 25, 2023
Last Updated
February 10, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in compliance with the applicable regulations.