COVID-19: A study to learn about the safety, local and systemic reactions, and the immune responses to the SARS-CoV-2 mRNA Vaccine (CVnCoV) when given to participants 45 years or older who have either a solid tumor or blood cancer and are already taking or about to start systemic anticancer therapy

Phase 1

Active, not recruiting

• Conditions: Vaccination for prophylaxis of coronavirus disease 2019 (COVID-19); MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001735-10-BE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-04
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 620

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) < 2.5 x upper limit of normal (ULN) (= 5 x ULN in case of liver metastases)
e.Total bilirubin = 1.5 x ULN
f.Estimated GFR = 30 ml/min/1.73m2 (according to local laboratory standards)
6.Participants expected to be compliant with protocol procedures and available for clinical follow-up to the last planned visit.
Sex and Contraceptive/Barrier Requirements
7.Male or female.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a.Male participants: no contraceptive requirement.
b.Female participants: females of childbearing potential can only be included in the study if a pregnancy test is negative at the screening visit and if they agree to use highly effective methods of contraception from the screening visit until 3 months following the last administration of study vaccine (see Section 10.4 for details).
Informed Consent
8.Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 310

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified