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Prevention of COVID19Phase 2CoviCompareMNCT04748471

Immunogenecity and Safety of VaccinemRNA-1273 in Elderly Volunteers (Over 65 y) Compared to Younger Ones (18-45y)

A Phase 2 study testing mRNA-1273 in people with Prevention of COVID19, run by Assistance Publique - Hôpitaux de Paris.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Prevention of COVID19
What is being tested?
mRNA-1273
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
10 Feb 2021to 25 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

No sites are listed yet.

Odile LAUNAY, Professor contact

01 58 41 28 58

odile.launay@aphp.fr

Jean Daniel LELIEVRE, Professor contact

01 49 81 24 09

jean-daniel.lelievre@aphp.fr

About this study

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

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.

Read the detailed description

Phase II, comparative, non-randomized trial assessing the immunogenicity and safety of vaccine candidate Moderna-1273 against SARS-CoV-2. A total of 180 volunteers will be included and vaccinated (2 doses, at day 1 and day 29), divided in 3 groups (60 volunteers 18 - 45 years old, 60 volunteers 65 - 74 years old, 60 volunteers at least 75 years old). Vaccinated volunteers of the three arms will be immune-monitored during 24 months via a battery of in vitro and ex vivo tests to comprehensively assess the course of humoral, cellular and mucosal immunity over time.

Being tested
mRNA-1273
Keywords
Vaccinology, Infectiology, Vaccine, COVID-19, Immunity, Immune, Cells, Mucosal immunity, Autoimmunity
Medical subject headings
COVID-19, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1273Biological

    SARS-CoV-2 vaccine

Study groups in NCT04748471
Study groupRoleWhat they receive
18-45 years oldExperimental18 - 45 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
Receives: Biological: mRNA-1273
65-74 years oldExperimental65 - 74 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
Receives: Biological: mRNA-1273
At least 75 years oldExperimentalAt least 75 years old (60 volunteers), 2 injections of mRNA-1273, at day 1 and day 29
Receives: Biological: mRNA-1273

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera

    Anti-SARS-CoV-2 Spike specific IgG Immunity acquisition

    Measured: Day 57 (28 days after second injection of mRNA-1273)

Secondary outcomes (10)

  1. Anti SARS-CoV -2 IgG, IgA and IgM (total and subclasses IgG1-4) as measured by ELISA.

    Assessment of humoral immunity-systemic response

    Measured: From Day 1 to Month 24

  2. Anti-SARS-CoV-2 neutralizing antibody (in vitro neutralisation assay.

    Assessment of humoral immunity-systemic response

    Measured: From Day 1 to Month 24

  3. Anti-SARS-CoV-2 -specific neutralizing antibody (Pseudo neutralisation assay using lentiviral phenotypes carrying specific SARS-Cov-2 proteins.

    Assessment of humoral immunity-systemic response

    Measured: From Day 1 to Month 24

  4. Fluorospot assays (TH1, TH2, TH17, Cytotoxicity). Phenotyping of antigen specific T-Cells via Mass cytometry, B cell repertoire and memory

    Assessment of cellular immunity acquisition

    Measured: From Day 1 to Month 24

  5. Mucosal SARS-CoV-2 -specific antibody via measure of sIgA, sIgM and IgG in saliva by specific home-made and commercially available ELISA assays.

    Assessment of mucosal immunity

    Measured: From Day 1 to Month 24

  6. Functionality of mucosal sIgA and sIgM by Antibody Dependent Cellular Cytotoxicity (ADCC) assay specific for SARS-CoV-2 mucosal IgA and IgM

    Assessment of mucosal immunity

    Measured: From Day 1 to Month 24

  7. Local and systemic reactogenicity

    Clinical safety evaluation

    Measured: From Day 1 to Month 24

  8. Determination of autoimmunity markers such as antibodies Anti-nuclear (unit measure: titers)

    Biological safety evaluation

    Measured: From Day 1 to Month 24

  9. Determination of autoimmunity markers such as antibodies Anti-ACL, Anti-β2-GP1, Rheumatoid factor (unit measure: U/L)

    Biological safety evaluation

    Measured: From Day 1 to Month 24

  10. Determination of autoimmunity markers such as antibodies Anti-GM1, Anti-MAG ( unit measure: pos/ne)

    Biological safety evaluation

    Measured: From Day 1 to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start10 Feb 2021 (estimated)
  3. Primary completion1 Jul 2021 (estimated)
  4. Study completion25 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04748471
Sponsor's protocol ID
APHP201504
Other IDs
2020-005889-34
Acronym
CoviCompareM
Status last verified
Jan 2021
First submitted
24 Jan 2021
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mRNA-1273 in people with Prevention of COVID19, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Odile LAUNAY, Professor (01 58 41 28 58, odile.launay@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera (time frame: Day 57 (28 days after second injection of mRNA-1273)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04748471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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