Vaccination for prophylaxis of coronavirus disease 2019 (COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084464 Term: COVID-19 immunization System Organ Class: 100000004865
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participant of 45 years of age or older, at the time of signing the informed consent. 2.For participants: For participants with malignancies (Path A, B or C): a.Path A: Participants with a solid tumor (i.e., NSCLC, CRC, breast cancer, prostate cancer) who have not received prior systemic anticancer therapy and are scheduled for treatment with either chemotherapy alone or chemotherapy in combination with another drug class (independent of intent). b.Path B: Participants with either a solid tumor (i.e., NSCLC, CRC, breast cancer, prostate cancer, RCC, melanoma) or hematologic malignant disease (lymphoma) who are scheduled to receive systemic anticancer therapy (independent of intent). NOTE: Participants who have received prior lines of systemic anticancer therapy are eligible provided exclusion criterion #5 is not violated. c.Path C: Participants with NSCLC on ongoing chemotherapy containing regimen. For healthy participants (Path D): d.Path D: participants who are generally healthy and have not had any malignant disease that required active treatment in the past 5 years. Note: healthy participant is defined as an individual who is in good general health. Participants with co-morbidities which are well controlled and clinically stable (on ongoing treatment) can be enrolled. For all participants: 3.Participants with estimated life expectancy > 13 months as per the judgement of the investigator. 4.Participants with ECOG performance status of 0 or 1 (See Section 10.5). 5.Participants who have adequate bone marrow and organ function as assessed by the following laboratory tests: a.Hemoglobin = 9 g/dL b.Absolute neutrophil count (ANC) > 1000/mm3 c.Platelet count > 100000/µl d.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range 310
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Prior/Concomitant Therapy 1.Use of any investigational or non-registered product (vaccine or drug other than anticancer therapy) within 28 days or 5 times half-life of the investigational product preceding the administration of the study vaccine, or planned use during the study period. 2.Receipt of any other approved vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or planned receipt of any vaccine within 28 days of study vaccine administration. 3.Receipt of any investigational, authorized or licensed, SARS-CoV-2 or other coronavirus vaccine prior to the administration of the CVnCoV study vaccine or planned receipt during the study. 4.Receipt of any investigational or licensed lipid nanoparticles (LNP)-formulated mRNA vaccine prior to the administration of the study vaccine. 5.Prior systemic anticancer therapy (applicable to Path A and Path B only) a.Path A: Any prior systemic anticancer therapy b.Path B: Systemic anticancer therapy within the last 30 days (4 months for immune check point inhibitors and 6 months for anti B cell antibodies) 6.Planned start of investigational anticancer therapy during the vaccination period or within 28 days after the second dose of the study vaccine. 7.Systemic corticosteroid therapy at doses exceeding 0.5 mg/kg/day prednisone equivalent for 14 consecutive days or more within the last 30 days before the scheduled start of study vaccine. 8.Receipt of biologics - most importantly but not limited to recombinant proteins/anti-inflammatory monoclonal antibodies (e.g. anti-TNF, anti-IL6, anti-17 monoclonal antibodies) - within the last 6 months before the scheduled start of study vaccine, with the exception of biologics to treat the underlying cancer or cancer related conditions. 9.Administration of immunoglobulins (Igs) within 3 months preceding the administration of any dose of the study vaccine. Medical Conditions 10.Prior transplantation of human cells, tissues and major organs (e.g. liver transplant) or candidates for any type of transplantation. 11.Participants not recovered from any surgery related acute toxicities. 12.History of immune-deficiency disorders. 13.History of angioedema (known C1 inhibitor deficiency). 14.History of any anaphylactic reactions. 15.Any known hypersensitivity reaction to any component of CVnCoV or aminoglycoside antibiotics. 16.Acute or currently active and serologically confirmed SARS-CoV-2 infection. 17.History of confirmed SARS, MERS or COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within 2 weeks prior to enrollment. 18.Evidence or history of any bleeding diathesis, irrespective of severity. 19.Participants with a significant acute or chronic medical or psychiatric illness (other than the underlying cancer for participants in Path A, B and C) that, in the opinion of the investigator, precludes study participation (e.g., participation poses a major health risk for the participant, renders the participant unable to meet the logistic requirements of the study, or may interfere with the reliability of the participant’s study results). These conditions may include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological or psychiatric illn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity profile of the 2-dose administration of CVnCoV vaccine;Secondary Objective: Secondary immunogenicity To evaluate the humoral immune response to the CVnCoV vaccine throughout the observation period Secondary safety To further evaluate the safety profile of the 2-dose administration of CVnCoV vaccine ;Primary end point(s): For the primary objective (safety): •The occurrence of solicited local AEs on each vaccination day and the following 7 days •The occurrence of solicited systemic AEs on each vaccination day and the following 7 days •The occurrence of unsolicited AEs on each vaccination day and the following 28 days •The occurrence of SAEs from first injection up to 28 days after the second injection •The occurrence of SAEs related to study vaccine from first injection up to 28 days after the second injection •The occurrence of AESIs from first injection up to 28 days after the second injection •The occurrence of AESIs related to study vaccine from first injection up to 28 days after the second injection ;Timepoint(s) of evaluation of this end point: 1-2: On each vaccination day and the following 7 days 3: On each vaccination day and the following 28 days 4-7: From first injection up to 28 days after the second injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary immunogenicity To evaluate the humoral immune response to the CVnCoV vaccine throughout the observation period At V4 (Day 43), V5 (Day 211) and V6 (Day 393) •Seroconversion for SARS-CoV-2 spike protein RBD antibodies, as measured by enzyme-linked immunosorbent assay (ELISA) •SARS-CoV-2 spike RBD protein-specific antibody levels in serum, as measured by ELISA •Seroconversion for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay •SARS-CoV-2 neutralizing antibody levels in serum Secondary safety To further evaluate the safety profile of the 2-dose administration of CVnCoV vaccine From first injection to the end of study (Day 393) •The occurrence of SAEs related to study vaccine •The occurrence of AESIs ;Timepoint(s) of evaluation of this end point: 1-4: Day 43, Day 211 and Day 393 5-6: From first injection to the end of study (Day 393) | — |
Countries
Austria, Belgium, Germany, Spain
Contacts
Public ContactBayer Clinical Trial Contacts
Bayer AG
Outcome results
None listed