Immunogenecity and Safety of VaccinemRNA-1273 in Elderly Volunteers (Over 65 y) Compared to Younger Ones (18-45y) (CoviCompareM)
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ClinicalTrials.gov Identifier: NCT04748471 |
Recruitment Status :
Not yet recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention of COVID19 | Biological: mRNA-1273 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Estimated Study Start Date : | February 10, 2021 |
Estimated Primary Completion Date : | July 1, 2021 |
Estimated Study Completion Date : | January 25, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: 18-45 years old
18 - 45 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
|
Biological: mRNA-1273
SARS-CoV-2 vaccine |
Experimental: 65-74 years old
65 - 74 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
|
Biological: mRNA-1273
SARS-CoV-2 vaccine |
Experimental: At least 75 years old
At least 75 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
|
Biological: mRNA-1273
SARS-CoV-2 vaccine |
- Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera [ Time Frame: Day 57 (28 days after second injection of mRNA-1273) ]Anti-SARS-CoV-2 Spike specific IgG Immunity acquisition
- Anti SARS-CoV -2 IgG, IgA and IgM (total and subclasses IgG1-4) as measured by ELISA. [ Time Frame: From Day 1 to Month 24 ]Assessment of humoral immunity-systemic response
- Anti-SARS-CoV-2 neutralizing antibody (in vitro neutralisation assay. [ Time Frame: From Day 1 to Month 24 ]Assessment of humoral immunity-systemic response
- Anti-SARS-CoV-2 -specific neutralizing antibody (Pseudo neutralisation assay using lentiviral phenotypes carrying specific SARS-Cov-2 proteins. [ Time Frame: From Day 1 to Month 24 ]Assessment of humoral immunity-systemic response
- Fluorospot assays (TH1, TH2, TH17, Cytotoxicity). Phenotyping of antigen specific T-Cells via Mass cytometry, B cell repertoire and memory [ Time Frame: From Day 1 to Month 24 ]Assessment of cellular immunity acquisition
- Mucosal SARS-CoV-2 -specific antibody via measure of sIgA, sIgM and IgG in saliva by specific home-made and commercially available ELISA assays. [ Time Frame: From Day 1 to Month 24 ]Assessment of mucosal immunity
- Functionality of mucosal sIgA and sIgM by Antibody Dependent Cellular Cytotoxicity (ADCC) assay specific for SARS-CoV-2 mucosal IgA and IgM [ Time Frame: From Day 1 to Month 24 ]Assessment of mucosal immunity
- Local and systemic reactogenicity [ Time Frame: From Day 1 to Month 24 ]Clinical safety evaluation
- Determination of autoimmunity markers such as antibodies Anti-nuclear (unit measure: titers) [ Time Frame: From Day 1 to Month 24 ]Biological safety evaluation
- Determination of autoimmunity markers such as antibodies Anti-ACL, Anti-β2-GP1, Rheumatoid factor (unit measure: U/L) [ Time Frame: From Day 1 to Month 24 ]Biological safety evaluation
- Determination of autoimmunity markers such as antibodies Anti-GM1, Anti-MAG ( unit measure: pos/ne) [ Time Frame: From Day 1 to Month 24 ]Biological safety evaluation

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
(Ill or febrile participants may be re-scheduled within the inclusion period when no longer presenting symptoms)
- 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
- The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
- Any condition which in the opinion of the investigator may interfere with the aim of the study
- Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit.
- Woman in childbearing without efficacious contraception (in the opinion of the investigator) for 31 days after treatment (2nd vaccine injection)
- People under legal protection measure (tutorship, curatorship or safeguard measures)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748471
Contact: Odile LAUNAY, Professor | 01 58 41 28 58 | odile.launay@aphp.fr | |
Contact: Jean Daniel LELIEVRE, Professor | 01 49 81 24 09 | jean-daniel.lelievre@aphp.fr |
Principal Investigator: | Odile LAUNAY, Professor | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT04748471 |
Other Study ID Numbers: |
APHP201504 2020-005889-34 ( EudraCT Number ) |
First Posted: | February 10, 2021 Key Record Dates |
Last Update Posted: | February 10, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vaccinology Infectiology Vaccine COVID-19 Immunity |
Immune Cells Mucosal immunity Autoimmunity |