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A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515147
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
CureVac AG

Brief Summary:
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.

Condition or disease Intervention/treatment Phase
Coronavirus Covid19 SARS-CoV-2 Severe Acute Respiratory Syndrome Biological: CVnCoV 6 μg Biological: CVnCoV 8 μg Biological: CVnCoV 8 μg (4 μg double dose) Biological: Hepatitis A vaccine Biological: Pneumococcal vaccine Biological: CVnCoV (Dose level confirmed in Part 1) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : November 9, 2021
Estimated Study Completion Date : November 9, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1, Group 1: CVnCoV 6 μg
Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old.
Biological: CVnCoV 6 μg
Participants will receive an intramuscular injection by needle in the deltoid area.
Other Name: CV07050101

Experimental: Part 1, Group 2: CVnCoV 6 μg
Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged over 60 years old.
Biological: CVnCoV 6 μg
Participants will receive an intramuscular injection by needle in the deltoid area.
Other Name: CV07050101

Experimental: Part 1, Group 3: CVnCoV 8 μg
Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged over 60 years old.
Biological: CVnCoV 8 μg
Participants will receive an intramuscular injection by needle in the deltoid area.
Other Name: CV07050101

Experimental: Part 1, Group 4: CVnCoV 8 μg
Participants will receive two doses of CVnCoV 4 μg vaccine on Day 1, followed by a single dose on Day 29. Participants in this group will be aged over 60 years old.
Biological: CVnCoV 8 μg (4 μg double dose)
Participants will receive two intramuscular injections by needle in the deltoid area.
Other Name: CV07050101

Active Comparator: Part 1, Group 5: Hepatitis A vaccine
Participants will be vaccinated with a hepatitis A vaccine on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old.
Biological: Hepatitis A vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.

Active Comparator: Part 1, Group 6: Pneumococcal vaccine
Participants will be vaccinated with a pneumococcal vaccine on Day 1 and Day 29. Participants in this group will be aged over 60 years old.
Biological: Pneumococcal vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.

Experimental: Part 2, Group 1: CVnCoV Recommended Part 2 Dose
Participants will be vaccinated with CVnCoV on Day 1 and Day 29. The dose level will be confirmed from Part 1. Participants in this group will be aged between 18 and 60 years old.
Biological: CVnCoV (Dose level confirmed in Part 1)
Participants will receive an intramuscular injection by needle in the deltoid area. The dose of this vaccine will be confirmed during Part 1 of this study.
Other Name: CV07050101

Active Comparator: Part 2, Group 2: Hepatitis A vaccine
Participants will be vaccinated with a hepatitis A vaccine on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old.
Biological: Hepatitis A vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.

Experimental: Part 2, Group 3: CVnCoV Recommended Part 2 Dose
Participants will be vaccinated with CVnCoV on Day 1 and Day 29. The dose level will be confirmed from Part 1. Participants in this group will be aged over 60 years old.
Biological: CVnCoV (Dose level confirmed in Part 1)
Participants will receive an intramuscular injection by needle in the deltoid area. The dose of this vaccine will be confirmed during Part 1 of this study.
Other Name: CV07050101

Active Comparator: Part 2, Group 4: Pneumococcal vaccine
Participants will be vaccinated with a pneumococcal vaccine on Day 1 and Day 29. Participants in this group will be aged over 60 years old.
Biological: Pneumococcal vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.




Primary Outcome Measures :
  1. Number of Participants with Solicited Local Adverse Events [ Time Frame: 7 days after vaccination ]
  2. Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale [ Time Frame: 7 days after vaccination ]
  3. Duration of Solicited Local Adverse Events [ Time Frame: 7 days after vaccination ]
  4. Number of Participants with Solicited Systemic Adverse Events [ Time Frame: 7 days after vaccination ]
  5. Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale [ Time Frame: 7 days after vaccination ]
  6. Duration of Solicited Systemic Adverse Events [ Time Frame: 7 days after vaccination ]
  7. Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine [ Time Frame: 7 days after vaccination ]
  8. Number of Participants with Unsolicited Adverse Events [ Time Frame: 28 days after vaccination ]
  9. Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale [ Time Frame: 28 days after vaccination ]
  10. Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine [ Time Frame: 28 days after vaccination ]
  11. Number of Participants with One or More Serious Adverse Events (SAEs) [ Time Frame: Baseline to Day 393 ]
  12. Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine [ Time Frame: Baseline to Day 393 ]
  13. Number of Participants with One or More Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline to Day 393 ]
  14. Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine [ Time Frame: Baseline to Day 393 ]
  15. Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies [ Time Frame: Day 29 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  16. Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies [ Time Frame: Day 43 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  17. Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum [ Time Frame: Day 29 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  18. Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum [ Time Frame: Day 43 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  19. Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies [ Time Frame: Day 29 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  20. Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies [ Time Frame: Day 43 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  21. Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies [ Time Frame: Day 29 ]
    Measured using an activity assay.

  22. Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies [ Time Frame: Day 43 ]
    Measured using an activity assay.

  23. Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum [ Time Frame: Day 29 ]
    Measured using an activity assay.

  24. Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum [ Time Frame: Day 43 ]
    Measured using an activity assay.

  25. Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies [ Time Frame: Day 29 ]
    Measured using an activity assay.

  26. Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies [ Time Frame: Day 43 ]
    Measured using an activity assay.


Secondary Outcome Measures :
  1. Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies [ Time Frame: Day 180, Day 208 and Day 393 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  2. Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum [ Time Frame: Day 180, Day 208 and Day 393 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  3. Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies [ Time Frame: Day 180, Day 208 and Day 393 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  4. Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies [ Time Frame: Day 180, Day 208 and Day 393 ]
    Measured using an activity assay.

  5. Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum [ Time Frame: Day 180, Day 208 and Day 393 ]
    Measured using an activity assay.

  6. Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies [ Time Frame: Day 180, Day 208 and Day 393 ]
    Measured using an activity assay.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female participants ≥18 years of age. A healthy participant is defined as an individual who is in good general health, according to the Investigator's assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator.
  • Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
  • Physical examination without clinically significant findings according to the Investigator's assessment.
  • Body mass index (BMI) ≥18.0 and ≤30.0 kg/m^2.
  • Female participants of childbearing potential: 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 (required if serum pregnancy test was performed more than 3 days before).
  • Female participants of childbearing potential must use highly effective methods of birth control from 2 weeks 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;
    • Intrauterine hormone-releasing systems;
    • Bilateral tubal occlusion;
    • Vasectomized partner;
    • Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).

Exclusion Criteria:

  • 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 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration.
  • Receipt of any investigational SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
  • Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
  • Use of hormonal therapy for gender reassignment.
  • 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 immune-mediated or autoimmune disease.
  • History of angioedema (known C1 inhibitor deficiency).
  • History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics.
  • History of or current alcohol and/or drug abuse.
  • Participants who are active smokers, were active smokers within the last year (including any vaping in the last year), or have a total smoking history ≥10 pack years.
  • History of confirmed SARS, MERS, or COVID-19 disease or known exposure (without any personal protective equipment) to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
  • Presence or evidence of significant uncontrolled acute or chronic medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to:

    • Uncontrolled respiratory disease (e.g., chronic obstructive pulmonary disease, asthma), including use of the following asthma medications: intravenous corticosteroids, leukotriene modifiers, biologics.
    • Uncontrolled cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery disease, pulmonary embolism).
    • History of myocarditis or pericarditis as an adult.
    • Diabetes mellitus (insulin-dependent).
    • Uncontrolled neurological disorders or Guillain-Barré syndrome or history of seizure, except for febrile seizures during childhood.
    • Current or past malignancy, unless completely resolved without sequelae for >5 years.
  • Foreseeable non-compliance with protocol, as judged by the Investigator.
  • For female participants: pregnancy or lactation.
  • Participants with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated. This includes participants on treatment with anticoagulants (e.g., vitamin K antagonists, novel oral anticoagulants, and heparin). Use of platelet aggregation inhibitors is not exclusionary.
  • Participants employed by the Sponsor, Investigator, or trial site, or relatives of research staff working on this trial.
  • Participants considered at the Investigator's discretion to be at increased risk of exposure to COVID-19 disease.

Information from the National Library of Medicine

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): NCT04515147


Contacts
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Contact: Clinical Trial Information +49 69 76805870 clinicaltrials@curevac.com

Locations
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Panama
Centro de vacunación internacional - CEVAXIN Panama Clinic Recruiting
Panama city, Panama, 0831
Peru
Instituto de Investigación Nutricional Recruiting
Lima, Peru, Lima - 12
Sponsors and Collaborators
CureVac AG
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Responsible Party: CureVac AG
ClinicalTrials.gov Identifier: NCT04515147    
Other Study ID Numbers: CV-NCOV-002
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CureVac AG:
Vaccine
SARS
COVID
Safety
Reactogenicity
Immunogenicity
Additional relevant MeSH terms:
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Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs