A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
Condition: Coronavirus; Covid19; SARS-CoV-2; Severe Acute Respiratory Syndrome
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Intervention: CVnCoV 6 μg; CVnCoV 12 μg; Hepatitis A vaccine; Pneumococcal vaccine; CVnCoV 12μg
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.; Participants will receive an intramuscular injection by needle in the deltoid area.; Participants will receive an intramuscular injection by needle in the deltoid area.; Participants will receive an intramuscular injection by needle in the deltoid area.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 668.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; SARS; COVID; Safety; Reactogenicity; Immunogenicity

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.
    

Eligibility 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.

          -  Participants are able to understand and willing to provide informed consent.

          -  Physical examination without clinically significant findings according to the
             Investigator's assessment.

          -  Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2.

          -  Female participants of childbearing potential: at the time of enrollment, negative
             human chorionic gonadotropin (hCG) pregnancy test (serum) for female participants
             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).

          -  Male participants should be instructed not to get their partners pregnant until 3
             months after the last administration.

        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 (primary
             dose or booster dose).

          -  Receipt of any investigational or licensed/authorized 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. A pack year is calculated by multiplying the number of packs of cigarettes
             smoked per day by the number of years the person has smoked.

          -  History of virologically-confirmed Severe Acute Respiratory Syndrome (SARS), Middle
             East Respiratory Syndrome (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.