A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARSCoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities

Phase 1

Conditions: Vaccination for prophylaxis of COVID-19 (adults with co morbidities)
MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2020-004070-22-BE

Lead Sponsor: CureVac AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1200

Inclusion Criteria

1. Male and female subjects =18 years of age with 1 or more co-morbidities as defined by the case definitions specified in the section Case definitions co-morbidities”.
2. For the co-morbidities chronic kidney disease, COPD, chronic cardiovascular disease and diabetes mellitus, the first 25 subjects per co-morbidity should include only mild to moderate cases as described in the section Case definitions co-morbidities”. Thereafter, more severe conditions may be recruited (see the section Overall design”) following iSRC and DSMB Chair approval.
3.Subject has no overt clinical signs or symptoms of COVID-19.
4. Subject has to sign the informed consent form (ICF) before any study procedures.
5. Subjects with a life expectancy of at least 1 year as per the Investigators assessment.
6. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
7. Physical examination without acute clinically significant findings according to the Investigator’s assessment.
8. 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).
Note: Women that are postmenopausal (defined as amenorrhea for = 12 consecutive months prior to screening without an alternative medical cause) or permanently sterilized will be considered as not having reproductive potential.
9. 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;
• Intrauterine hormone-releasing systems;
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 840
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion Criteria

1. A previous clinical and laboratory-confirmed diagnosis of COVD-19 within the last six months prior to screening.
2. 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.
3. 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. Planned vaccination with an inactivated influenza vaccine is permitted.
4. Receipt of any investigational, authorized or licensed SARS-CoV-2, other coronavirus vaccine or any other lipid nanoparticle (LNP) containing mRNA vaccine prior to the administration of the trial vaccine. For authorized or licensed SARS-CoV-2: planned administration during the trial up to 6 weeks after the foreseen date of second dose administration of CVnCoV.
5. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) for >14 days in total within 6 months prior to the administration of the 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.
Note: This exclusion does not apply to the renal transplant cases and is at the Investigator’s discretion for subjects with other co-morbidities (e.g., COPD).
6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, excluding the co-morbidities specified in the section Case definitions co-morbidities”.
(Subjects with chronic HIV infection with controlled Hep B infection with therapy or aviremic Hep C may be eligible for the trial, based on the Investigator’s judgment).
7. History of immune mediated or autoimmune disease.
8. History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics.
9. History of or current alcohol and/or drug abuse.
10. History of confirmed SARS or MERS disease.
11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
12. Presence of evidence of significant uncontrolled acute or chronic medical or psychiatric illness, excluding the co-morbidities specified in the section Case definitions co-morbidities”. Significant medical or psychiatric illnesses include but are not limited to:
• Uncontrolled respiratory disease
• 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.
13. Foreseeable non-compliance with protocol, as judged by the Investigator.
14. For female subjects: pregnancy or lactation
15. Subjects with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated. This includes subjects on treatment with anticoagulants (e.g., vitamin K antagonists, novel oral anticoagulants, and heparin). Use of platelet aggregation inhibitors is not exclusionary. However, use of anticoagulants is accepted in certain co-morbid conditions according to the clinical Investigator’s judgment and if the INR remains =3.
16. S