A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
Condition: Severe Acute Respiratory Syndrome; Coronavirus; SARS-CoV-2; COVID-19
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Intervention: CVnCoV Vaccine; Placebo
Intervention description: Participants will receive an intramuscular injection by needle in the deltoid area.; Participants will receive an intramuscular injection by needle in the deltoid area.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
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.
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Reactogenicity; Immunogenicity; Vaccine; CEPI

Summary:

      This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose
      administrations of CVnCoV at different dose levels.
    

Eligibility 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 participants
             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 (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 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 participants 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 participants 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.