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CoronavirusPhase 3NCT04838847

A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19

A Phase 3 study testing CVnCoV Vaccine in people with Coronavirus and Covid19, run by CureVac.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary objective of this study is to evaluate the humoral immune response to CVnCoV in elderly adults aged ≥65 years and younger adults aged 18-45 years, 14 days after the second dose administration. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus, Covid19, SARS-CoV-2
What is being tested?
CVnCoV Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Oct 2021to Sep 2022
Phase
Phase 3
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

  • Male or female participants between the ages of 18 and 45 years or aged 65 years and older.
  • Healthy adults or adults with pre-existing medical conditions who are in a stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
  • Capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol.
  • Physical examination without clinically significant findings according to the Investigator's assessment.
  • Affiliated to a social security system (except state medical aid).
  • Females: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if serum pregnancy test was performed more than 3 days before).
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  • Note: Women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening [Day 1]) or permanently sterilized will be considered as not having reproductive potential.
  • Females of childbearing potential must use highly effective of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
  • Intrauterine devices (IUDs);
  • Intrauterine hormone-releasing systems (IUSs);
  • Bilateral tubal occlusion;
  • Vasectomized partner.
  • Same sex relationships.
  • Sexual abstinence (periodic abstinence [e.g., calendar, ovulation symptothermal and post-ovulation methods]) and withdrawal are not acceptable methods.

Who cannot join

  • Participant ill or febrile (body temperature ≥38.0°C) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (COVID-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms).
  • Previous or currently active SARS-CoV-2 infection (currently as confirmed by reactive polymerase chain reaction [PCR] or positive serology test prior to the first trial vaccine administration).
  • Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
  • Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration.
  • Receipt of any investigational or licensed/authorized SARS-CoV-2 or other coronavirus vaccine, including non-specific vaccines such as Bacillus Calmette-Guérin, prior to the administration of the trial vaccine or planned administration during the trial.
  • Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and Methotrexate) for > 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. The use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted.
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  • Receipt of any lipid nanoparticles (LNP)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine.
  • Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection and hepatitis C virus infection.
  • History of potential immune-mediated disease.
  • History of angioedema.
  • Any known allergy to any component of investigational CVnCoV or aminoglycoside antibiotics.
  • History of or current alcohol and/or drug abuse.
  • History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (self-reported).
  • Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial.
  • Participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the Investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). These include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. However, those with controlled and stable cases can be included in the trial.
  • Foreseeable non-compliance with protocol as judged by the Investigator.
  • For females: pregnancy or lactation.
  • History of any anaphylactic reactions.
  • Participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture.
  • Participants employed by the Sponsor, Investigator or trial site, or relatives of research staff working on this trial.
  • Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

About this study

Official title: COVID-19 (CoviCompareCV): A Phase 3, Non-randomized, Open Label Clinical Trial to Evaluate the Immunogenicity and Safety of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Adults Aged 65 Years or Above Compared to Younger Adults Aged 18-45 Years

The primary objective of this study is to evaluate the humoral immune response to CVnCoV in elderly adults aged ≥65 years and younger adults aged 18-45 years, 14 days after the second dose administration.

Being tested
CVnCoV Vaccine
Keywords
Covid19, SARS-CoV-2 mRNA vaccine, CVnCoV, Vaccine, SARS, COVID, Safety, Immunogenicity
Medical subject headings
Coronavirus Infections, COVID-19, Severe Acute Respiratory Syndrome

What participants receive

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

  • CVnCoV VaccineBiological

    Also called CV07050101

    Intramuscular (IM) injection

Study groups in NCT04838847
Study groupRoleWhat they receive
Participants / Healthy Participants Aged ≥65 YearsExperimentalParticipants will be vaccinated with CVnCoV 12 μg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Receives: Biological: CVnCoV Vaccine
Participants / Healthy Participants Aged 18-45 YearsExperimentalParticipants will be vaccinated with CVnCoV 12 μg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Receives: Biological: CVnCoV Vaccine

What is being measured

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

  1. Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum

    Measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Day 43

Secondary outcomes (20)

  1. Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum

    Measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Month 6, Month 12 and Month 26

  2. Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulins in Serum

    Antibody concentrations against SARS-CoV-2 spike protein-specific immunoglobulin A (IgA) and immunoglobulin M (IgM) in serum.

    Measured by enzyme-linked immunosorbent assay (ELISA).

    Measured: Day 29, Day 43, Month 6, Month 12 and Month 26

  3. Number of Participants With Neutralizing Antibody Titers Against SARS-CoV-2 Spike Protein in Serum

    Measured by an in vitro neutralization assay.

    Measured: Day 29, Day 43, Month 6, Month 12 and Month 26

  4. Number of Participants Who Experience a Solicited Local Adverse Event (AE)

    Measured: Up to 7 days after vaccination

  5. Intensity of Solicited Local Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale

    Intensity of solicited local AEs will be graded per the FDA Toxicity Grading Scale at grades 0-3, where higher grades indicate a worse outcome.

    Measured: Up to 7 days after vaccination

  6. Duration of Solicited Local Adverse Events (AEs)

    Measured: Up to 7 days after vaccination

  7. Number of Participants Who Experience a Solicited Systemic Adverse Event (AE)

    Measured: Up to 7 days after vaccination

  8. Intensity of Solicited Systemic Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale

    Intensity of solicited systemic AEs will be graded per the FDA Toxicity Grading Scale at grades 0-3, where higher grades indicate a worse outcome.

    Measured: Up to 7 days after vaccination

  9. Duration of Solicited Systemic Adverse Events (AEs)

    Measured: Up to 7 days after vaccination

  10. Number of Participants Who Experience a Treatment-related Solicited Systemic Adverse Event (AE)

    Measured: Up to 7 days after vaccination

  11. Number of Participants Who Experience an Unsolicited Adverse Event (AE)

    Measured: Up to 28 days after vaccination

  12. Intensity of Unsolicited Adverse Events (AEs) per the Investigator's Assessment

    Measured: Up to 28 days after vaccination

  13. Number of Participants Who Experience a Treatment-related Unsolicited Adverse Event (AE)

    Measured: Up to 28 days after vaccination

  14. Number of Participants Who Experience a Medically Attended Adverse Event (AE)

    Measured: Day 1 up to approximately 26 months

  15. Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event (AE)

    Measured: Day 1 up to approximately 26 months

  16. Number of Participants Who Experience a Medically Attended Serious Adverse Event (SAE)

    Measured: Day 1 up to approximately 26 months

  17. Number of Participants Who Experience a Medically Attended Treatment-related Serious Adverse Event (SAE)

    Measured: Day 1 up to approximately 26 months

  18. Number of Participants Who Experience a Medically Attended Adverse Event of Special Interest (AESI)

    Measured: Day 1 up to approximately 26 months

  19. Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event of Special Interest (AESI)

    Measured: Day 1 up to approximately 26 months

  20. Number of Participants With Virologically-confirmed SARS-CoV-2 Infection

    Measured by reverse transcription polymerase chain reaction (RT-PCR).

    Measured: Screening up to approximately 26 months

Timeline

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

  1. First posted9 Apr 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completionJan 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Why it stopped: The study was withdrawn based on an assessment of immunogenicity in elderly adults.

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 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838847
Sponsor's protocol ID
CV-NCOV-012
Other IDs
2020-005064-54
Status last verified
Apr 2021
First submitted
8 Apr 2021
Last updated
20 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CVnCoV Vaccine in people with Coronavirus and Covid19, run by CureVac.

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 16 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: withdrawn, as of the sponsor's last update on 20 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum (time frame: Day 43). 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 NCT04838847.

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 20 Aug 2021.

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