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A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults

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: NCT04449276
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations (CEPI)
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 CVnCoV at different dose levels.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus SARS-CoV-2 COVID-19 Biological: CVnCoV Vaccine Drug: Placebo Phase 1

Detailed Description:
Funded by Coalition for Epidemic Preparedness Innovations (CEPI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Masking Description: In the initial part of the dose escalation, participants will be enrolled in sentinel groups in an open manner. In the second part, participants will be enrolled in placebo-controlled groups in an observer-blind manner.
Primary Purpose: Prevention
Official Title: COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose-escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation CVnCoV

Participants will be vaccinated with CVnCoV at escalating dose levels on Day 1 and Day 29. Safety data will inform the decision to continue enrolling at the current dose level, or to proceed to dose escalation. Initially, dose levels of 2, 4 and 8 μg will be evaluated.

Dose levels of 2, 4, 6, 8 and 12µg will be evaluated with potential increase to dose levels up to 20 μg

Biological: CVnCoV Vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.
Other Name: CV07050101

Placebo Comparator: Dose Escalation Placebo
Participants will be given placebo on Day 1 and Day 29.
Drug: Placebo
Participants will receive an intramuscular injection by needle in the deltoid area.




Primary Outcome Measures :
  1. Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination [ Time Frame: Up to 24 hours after vaccination on Day 1 ]
    This data will be collected for decisions on subsequent vaccination of an additional open-label sentinel group with the same dose level.

  2. Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination [ Time Frame: Up to 60 hours after vaccination on Day 1 ]
    This data will be collected for decisions on dose escalation as well as continuation of enrollment at the same dose level in the observer-blind placebo-controlled part of the trial.

  3. Number of Participants with Solicited Local Adverse Events [ Time Frame: 7 days after vaccination ]
  4. Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale [ Time Frame: 7 days after vaccination ]
  5. Duration of Solicited Local Adverse Events [ Time Frame: 7 days after vaccination ]
  6. Number of Participants with Solicited Systemic Adverse Events [ Time Frame: 7 days after vaccination ]
  7. Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale [ Time Frame: 7 days after vaccination ]
  8. Duration of Solicited Systemic Adverse Events [ Time Frame: 7 days after vaccination ]
  9. Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine [ Time Frame: 7 days after vaccination ]
  10. Number of Participants with Unsolicited Adverse Events [ Time Frame: 28 days after vaccination ]
  11. Intensity of Unsolicited Adverse Events Assessed by the Investigator [ Time Frame: 28 days after vaccination ]
  12. Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine [ Time Frame: 28 days after vaccination ]
  13. Number of Participants with One or More Serious Adverse events (SAEs) [ Time Frame: Baseline to Day 393 ]
  14. Number of Participants with One or More Serious Adverse events (SAEs) Considered Related to Trial Vaccine [ Time Frame: Baseline to Day 393 ]
  15. Number of Participants with One or More Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline to Day 393 ]
  16. Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine [ Time Frame: Baseline to Day 393 ]

Secondary Outcome Measures :
  1. Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies [ Time Frame: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  2. Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum [ Time Frame: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 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: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  4. Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies [ Time Frame: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393 ]
    Measured using an activity assay.

  5. Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum [ Time Frame: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393 ]
    Measured using an activity assay.

  6. Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies [ Time Frame: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 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 to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for all participants:

  • Healthy male and female participants aged 18 to 60 years inclusive. Healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication.
  • Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
  • Physical examination and laboratory results without clinically significant findings according to the Investigator's assessment.
  • Body Mass Index (BMI) ≥18.0 and ≤30.0kg/m^2 (≥18.0 and ≤32.0kg/m2 for subjects with SARS-CoV-2 positive serology).
  • 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 the serum pregnancy test was performed more than 3 days before).
  • Females of childbearing potential must use highly effective methods 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;
    • Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).

Exclusion Criteria:

The following criterion applies to all open-label sentinel participants:

  • Participants with SARS-CoV-2 positive serology as confirmed by testing at enrollment.

The following criteria apply to all participants, except those with SARS-CoV-2 positive serology:

  • Participants considered at the Investigator's discretion to be at increased risk to acquire COVID-19 disease (including, but not limited to, health care workers with direct involvement in patient care or care of long-term care recipients).
  • History of confirmed COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.

The following criteria apply to all participants:

  • Use of any investigational or non-registered product (drug or vaccine) 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 SARS-CoV-2 or other CoV vaccine prior to the administration of the trial vaccine.
  • Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied steroids. Corticosteroids used in the context of COVID-19 disease of subjects with SARS CoV 2 positive serology are not exclusionary.
  • 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 a pIMD (potential immune-mediated disease).
  • History of angioedema.
  • Any known allergy, including allergy to any component of CVnCoV or aminoglycoside antibiotics. A history of hay fever or seasonal allergies (pollinosis) that does not require current treatment (e.g., anti-histamines) during the vaccination period (1 month before first vaccination until 1 month after last vaccination) is not exclusionary.
  • 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.
  • Active or currently active SARS-CoV-2 infection as confirmed by reactive PCR within 3 days of first trial vaccine administration.
  • History of confirmed SARS or MERS
  • Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
  • Presence or evidence of significant acute or chronic, medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to:

    • Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.
    • Respiratory disease with clinically significant dyspnea in the last 5 years (except COVID-19 disease in subjects with SARS-CoV-2 positive serology).
    • Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.
    • Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery disease, pulmonary embolism) or history of myocarditis or pericarditis as an adult.
    • Elevated blood pressure or hypertension, even if well-controlled.
    • Diabetes mellitus type 1 or 2.
    • History of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of 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 females: Pregnancy or lactation.
  • History of any anaphylactic reactions.
  • Participants with impaired coagulation or any bleeding disorder in whom an IM injection or a blood draw is contraindicated.
  • Participants employed by the Sponsor, Investigator or trial site, or relatives of research staff working on this trial.

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): NCT04449276


Contacts
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Contact: Clinical Trial Information +49 69 7680587 0 clinicaltrials@curevac.com

Locations
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Belgium
Universitair Ziekenhuis Ghent Recruiting
Ghent, Belgium, 9000
Contact: University Hospital Ghent CEVAC-Clinical Trial Unit         
Germany
Ludwig-Maximilians-Universität München Recruiting
München, Bavaria, Germany, 80802
Contact: Division of Infectious Diseases and Tropical Medicine (DITM) University Hospital of Munich (LMU)         
Medical University Hannover (MHH) Recruiting
Hannover, Germany, 30625
Contact: Medical University Hannover Clinical Trial Unit: Clinical Research Center Core Facility         
University Hospital Tübingen Institut für Tropenmedizin Recruiting
Tübingen, Germany, 72074
Sponsors and Collaborators
CureVac AG
Coalition for Epidemic Preparedness Innovations (CEPI)
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Responsible Party: CureVac AG
ClinicalTrials.gov Identifier: NCT04449276    
Other Study ID Numbers: CV-NCOV-001
2020-001286-36 ( EudraCT Number )
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: June 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:
Safety
Reactogenicity
Immunogenicity
Vaccine
CEPI
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases