COVID-19: A Study to Evaluate Safety, Reactogenicity and... | NCT04860258 | Trialant
NCT04860258
Sponsor
CureVac
Status
Terminated
Last Update Posted
May 13, 2022Actual
Enrollment
129Actual
Phase
Phase 3
Conditions
Coronavirus
Covid19
SARS-CoV-2
Severe Acute Respiratory Syndrome
Interventions
CVnCoV Vaccine
Countries
Belgium
Protocol Section
Identification Module
NCT ID
NCT04860258
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CV-NCOV-003
Secondary IDs
ID
Type
Description
Link
2020-004070-22
EudraCT Number
Brief Title
COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities
Official Title
COVID-19: A Phase 3 Multicenter Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Above With Co-morbidities
Acronym
Not provided
Organization
CureVacINDUSTRY
Status Module
Record Verification Date
Apr 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The Principal Investigators and CureVac decided to terminate the trial early following a change to the risk/benefit profile.
Expanded Access Info
No
Start Date
Apr 22, 2021Actual
Primary Completion Date
Sep 21, 2021Actual
Completion Date
Sep 21, 2021Actual
First Submitted Date
Apr 22, 2021
First Submission Date that Met QC Criteria
Apr 22, 2021
First Posted Date
Apr 26, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 20, 2022
Results First Submitted that Met QC Criteria
Apr 20, 2022
Results First Posted Date
May 13, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 20, 2022
Last Update Posted Date
May 13, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CureVacINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives of this study are to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine CVnCoV, and to evaluate the humoral immune responses 14 days after 2 dose administrations of CVnCoV.
Detailed Description
Study participants with the following mild to moderate per protocol defined co-morbidities will be recruited: chronic kidney disease (CKD); cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), type-2-diabetes. After safety data review, recruitment for severe cases will be opened. No severity classification will be done for study participants with chronic human immunodeficiency virus (HIV) infection with stable aviremia 12 months prior enrollment, for renal transplant patients if stable under medication for at least 6 months prior enrollment, and for study participants with a body mass index > 32 kg/m^2.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Conditions Module
Conditions
Coronavirus
Covid19
SARS-CoV-2
Severe Acute Respiratory Syndrome
Keywords
Covid19
CVnCoV
SARS-CoV-2 mRNA vaccine
Vaccine
SARS
COVID
Safety
Reactogenicity
Immunogenicity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
129Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CVnCoV Vaccine
Experimental
Participants will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29.
Biological: CVnCoV Vaccine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CVnCoV Vaccine
Biological
Intramuscular (IM) injection in the deltoid area, preferably in the non-dominant arm.
CVnCoV Vaccine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 were included.
Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Baseline and Days 29, 120, 211 and 393
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female participants ≥18 years of age with 1 or more co-morbidities.
For the co-morbidities chronic kidney disease, chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease and diabetes mellitus, the first 25 participants per co-morbidity should include only mild to moderate cases. Thereafter, more severe conditions may be recruited following Internal Safety Review Committee (iSRC) and Data Safety Monitoring Board (DSMB) Chair approval.
Participant has no overt clinical signs or symptoms of COVID-19.
Participant has to sign the informed consent form (ICF) before any trial procedures.
Participants with a life expectancy of at least 1 year as per the Investigator's assessment.
Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
Physical examination without acute clinically significant findings according to the Investigator's assessment.
Female participants: 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.
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.
Exclusion Criteria:
A previous clinical and laboratory-confirmed diagnosis of COVID-19 within the last six months prior to screening.
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. Planned vaccination with an inactivated influenza vaccine is permitted.
Receipt of any investigational, authorized or licensed SARS-CoV-2, other coronavirus vaccine or any other lipid nanoparticles (LNP)-containing messenger ribonucleic acid 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.
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 participants with other co-morbidities (e.g., COPD).
Participants with chronic human immunodeficiency virus (HIV) infection with controlled Hepatitis B infection with therapy or aviremic Hepatitis C may be eligible for the trial, based on the Investigator's judgment.
History of immune-mediated or autoimmune disease.
History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics.
History of or current alcohol and/or drug abuse.
History of confirmed severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) disease.
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, excluding the co-morbidities specified in the protocol. 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
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 IM 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. However, use of anticoagulants is accepted in certain co-morbidities according to the clinical Investigator's judgment and if the international normalized ratio (INR) remains ≤3.
Participants employed by the Sponsor, Investigator, or trial site, or relatives of research staff working on this trial.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Centre Hospitalier Universitaire Saint-Pierre
Brussels
1000
Belgium
Université Libre de Bruxelles (ULB) - Hopital Erasme
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Of the 172 participants who were screened, 129 participants with co-morbidities known to increase the risk for (severe) COVID-19 were enrolled. Participants received investigational severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccine (CVnCoV) 12 µg on Day 1 and Day 29.
Recruitment Details
This trial was performed in Belgium between 22 April 2021 and 21 September 2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 27, 2021
Apr 13, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
CV07050101
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.
Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities.
Severe: an event that prevented normal everyday activities.
Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial
An SAE was defined as any untoward medical occurrence that, at any dose:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent disability/incapacity.
Was a congenital anomaly/birth defect in the offspring of the participant.
Was an important medical event.
The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Up to Day 57
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
AESIs included:
AEs with a suspected immune-mediated etiology including potential immune-mediated diseases.
Other AEs relevant to SARS-CoV-2 vaccine development or the target disease.
Non-serious intercurrent medical conditions that may affect the immune response to vaccination was collected throughout the trial.
Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Up to Day 57
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Baseline and Day 43
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Day 43
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Baseline and Day 43
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Day 43
GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Days 29, 120, 211 and 393
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Baseline and Days 29 and 120
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Days 29 and 120
Brussels
1070
Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège
4000
Belgium
FG001
Chronic Obstructive Pulmonary Disease (COPD)
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
FG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a body mass index (BMI) >32 kg/m².
FG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
FG004
Chronic Human Immunodeficiency Virus (HIV) Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
FG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
FG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
FG0001 subjects
FG0011 subjects
FG00252 subjects
FG00333 subjects
FG00433 subjects
FG0057 subjects
FG0062 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG00248 subjects
FG00332 subjects
FG00429 subjects
FG0056 subjects
FG0062 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
FG0044 subjects
FG0051 subjects
FG0060 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
FG0044 subjects
FG0051 subjects
FG0060 subjects
The Safety Analysis Set (SAS) consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
BG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
BG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
BG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
BG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
BG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
BG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG00252
BG00333
BG00433
BG0057
BG0062
BG007129
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.0± NAStandard deviation could not be calculated as a single participant was analyzed.
BG00173.0± NAStandard deviation could not be calculated as a single participant was analyzed.
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0001
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
Posted
Count of Participants
Participants
Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00252
OG003
Title
Denominators
Categories
Any solicited local AEs
Title
Measurements
OG0001
OG0010
OG00240
OG003
Primary
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
The SAS including only participants who experienced solicited local and systemic AEs.
Posted
Count of Participants
Participants
Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Primary
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 were included.
The SAS including only participants who experienced solicited local and systemic AEs.
Posted
Mean
Standard Deviation
days
Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Primary
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
Posted
Count of Participants
Participants
Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Primary
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.
Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities.
Severe: an event that prevented normal everyday activities.
The SAS including only participants who experienced unsolicited AEs.
Posted
Count of Participants
Participants
Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
Primary
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial
An SAE was defined as any untoward medical occurrence that, at any dose:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent disability/incapacity.
Was a congenital anomaly/birth defect in the offspring of the participant.
Was an important medical event.
The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
Posted
Count of Participants
Participants
Up to Day 57
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Primary
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
AESIs included:
AEs with a suspected immune-mediated etiology including potential immune-mediated diseases.
Other AEs relevant to SARS-CoV-2 vaccine development or the target disease.
Non-serious intercurrent medical conditions that may affect the immune response to vaccination was collected throughout the trial.
Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
Posted
Count of Participants
Participants
Up to Day 57
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
Primary
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
The Per Protocol Immunogenicity subset (PPI) included all participants who received both doses within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, had not received medical treatments (such as blood products, immunoglobulin therapy) that may interfere with any of the immunogenicity measurements and had at least 1 blood sample collected starting at 14 days (Day 43) post-second vaccination available for analysis.
Posted
Number
count of seroconverted participants
Baseline and Day 43
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
Primary
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
The PPI included all participants who received both doses within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, had not received medical treatments (such as blood products, immunoglobulin therapy) that may interfere with any of the immunogenicity measurements and had at least 1 blood sample collected starting at 14 days (Day 43) post-second vaccination available for analysis.
Posted
Geometric Mean
Standard Deviation
titers
Day 43
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
Primary
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
A subset of the PPI population was included in the measurement of neutralizing activity.
Posted
Number
count of seroconverted participants
Baseline and Day 43
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
Primary
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
A subset of the PPI population was included in the measurement of neutralizing activity.
Posted
Geometric Mean
Standard Deviation
titers
Day 43
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
Secondary
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
The PPI. No data was collected for Days 211 and 393 due to early study termination.
Posted
Number
count of seroconverted participants
Baseline and Days 29, 120, 211 and 393
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
Secondary
GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
The PPI. No data was collected for Days 211 and 393 due to early study termination.
Posted
Geometric Mean
Standard Deviation
titers
Days 29, 120, 211 and 393
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
Secondary
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
A subset of the PPI population was included in the measurement of neutralizing activity.
Posted
Number
count of seroconverted participants
Baseline and Days 29 and 120
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
Secondary
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
A subset of the PPI population was included in the measurement of neutralizing activity.
Posted
Geometric Mean
Standard Deviation
titers
Days 29 and 120
ID
Title
Description
OG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
OG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
Time Frame
Up to Day 57
Description
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR <60 mL/min/1.73m².
0
1
0
1
1
1
EG001
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
0
1
0
1
1
1
EG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
0
52
0
52
50
52
EG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
0
33
0
33
32
33
EG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
0
33
0
33
33
33
EG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
0
7
1
7
7
7
EG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
0
2
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Empyema
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected2 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Eye pain
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG00256 events26 affected52 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG00211 events9 affected52 at risk
EG003
Chills
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG00234 events24 affected52 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG002142 events44 affected52 at risk
EG003
Feeling abnormal
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG00259 events39 affected52 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG00220 events14 affected52 at risk
EG003
Swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0024 events4 affected52 at risk
EG003
Vaccination site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0025 events3 affected52 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Syphilis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected52 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG00254 events27 affected52 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events3 affected52 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG00268 events35 affected52 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG002106 events39 affected52 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected52 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected52 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0025 events5 affected52 at risk
EG003
Hot flush
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events3 affected52 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected52 at risk
EG003
Participant recruitment was smaller than planned due to early recruitment halt. The Principal Investigators and CureVac decided to terminate the trial early following a change to the risk/benefit profile.
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0010
OG00246
OG00329
OG00431
OG0057
OG0062
Title
Denominators
Categories
Any solicited local AEs
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG00240
ParticipantsOG00328
ParticipantsOG00426
ParticipantsOG0056
ParticipantsOG0062
Title
Measurements
Grade 1
OG0001
OG0010
OG00230
OG003
Any solicited systemic AEs
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG00246
ParticipantsOG00329
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0010
OG00246
OG00329
OG00431
OG0057
OG0062
Title
Denominators
Categories
Any solicited local AEs
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG00240
ParticipantsOG00328
ParticipantsOG00426
ParticipantsOG0056
ParticipantsOG0062
Title
Measurements
OG0001.0± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0022.2± 1.11
OG0032.1± 1.21
OG004
Any solicited systemic AEs
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG00246
ParticipantsOG00329
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00252
OG00333
OG00433
OG0057
OG0062
Title
Denominators
Categories
Any unsolicited AEs
Title
Measurements
OG0001
OG0011
OG00227
OG00314
OG00419
OG0054
OG0061
Any related unsolicited AEs
Title
Measurements
OG0001
OG0011
OG00212
OG003
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00227
OG00314
OG00419
OG0054
OG0061
Title
Denominators
Categories
Title
Measurements
Mild
OG0001
OG0010
OG0026
OG0034
OG0048
OG0052
OG0061
Moderate
OG0000
OG0011
OG00217
OG0037
OG004
Severe
OG0000
OG0010
OG0024
OG0033
OG004
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00252
OG00333
OG00433
OG0057
OG0062
Title
Denominators
Categories
Any SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
Any related SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00252
OG00333
OG00433
OG0057
OG0062
Title
Denominators
Categories
Any AESIs
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0041
OG0050
OG0060
Any Related AESIs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00238
OG00321
OG00418
OG0055
OG0062
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG00234
OG00319
OG00416
OG0054
OG0061
OG002
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI >32 kg/m².
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00238
OG00321
OG00418
OG0055
OG0062
Title
Denominators
Categories
Title
Measurements
OG000518.410± NAStandard deviation could not be calculated as a single participant was analyzed.
OG00150.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0021576.121± 7.5115
OG0031385.663± 5.8935
OG004968.795± 4.7759
OG005183.523± 2.4423
OG006416.051± 20.0136
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00223
OG00311
OG00411
OG0055
OG0062
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG00216
OG0036
OG0047
OG0050
OG0061
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00223
OG00311
OG00411
OG0055
OG0062
Title
Denominators
Categories
Title
Measurements
OG00014.140± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0015.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG00257.426± 9.1427
OG00316.042± 4.0790
OG00418.778± 3.9937
OG0055.000± 1.0000
OG00610.000± 2.6651
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00239
OG00321
OG00418
OG0055
OG0062
Title
Denominators
Categories
Day 29
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00239
ParticipantsOG00321
ParticipantsOG00418
ParticipantsOG0055
ParticipantsOG0062
Title
Measurements
OG0000
OG0010
OG00213
OG003
Day 120
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0027
ParticipantsOG0032
Day 211
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 393
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00239
OG00321
OG00418
OG0055
OG0062
Title
Denominators
Categories
Day 29
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00239
ParticipantsOG00321
ParticipantsOG00418
ParticipantsOG0055
ParticipantsOG0062
Title
Measurements
OG00050.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG00150.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG002234.464± 9.4598
OG003
Day 120
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0027
ParticipantsOG0032
Day 211
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 393
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00224
OG00311
OG00411
OG0055
OG0062
Title
Denominators
Categories
Day 29
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00224
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG0055
ParticipantsOG0062
Title
Measurements
OG0000
OG0010
OG0027
OG003
Day 120
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0031
OG003
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
OG004
Chronic HIV Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (<50 copies/mL) and CD4 count >350/mL as documented by blood samples taken within 12 months before enrollment. Viral load <50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
OG005
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication [HbA1c <58 mmol/mol (7.45%)].
OG006
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
Units
Counts
Participants
OG0001
OG0011
OG00224
OG00311
OG00411
OG0055
OG0062
Title
Denominators
Categories
Day 29
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00224
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG0055
ParticipantsOG0062
Title
Measurements
OG0005.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0015.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG00217.311± 7.4073
OG003
Day 120
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0031
18 events
11 affected
33 at risk
EG00417 events9 affected33 at risk
EG0053 events3 affected7 at risk
EG0060 events0 affected2 at risk
6 events
6 affected
33 at risk
EG00414 events10 affected33 at risk
EG0052 events2 affected7 at risk
EG0062 events1 affected2 at risk
23 events
20 affected
33 at risk
EG00423 events14 affected33 at risk
EG0051 events1 affected7 at risk
EG0062 events1 affected2 at risk
56 events
25 affected
33 at risk
EG00458 events22 affected33 at risk
EG00515 events7 affected7 at risk
EG00610 events2 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0052 events1 affected7 at risk
EG0060 events0 affected2 at risk
40 events
27 affected
33 at risk
EG00441 events27 affected33 at risk
EG0058 events6 affected7 at risk
EG0063 events2 affected2 at risk
11 events
10 affected
33 at risk
EG0048 events6 affected33 at risk
EG0052 events2 affected7 at risk
EG0062 events1 affected2 at risk
0 events
0 affected
33 at risk
EG0042 events2 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
2 events
2 affected
33 at risk
EG0043 events2 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0042 events2 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0043 events3 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected2 at risk
31 events
15 affected
33 at risk
EG00416 events9 affected33 at risk
EG00515 events6 affected7 at risk
EG0062 events1 affected2 at risk
1 events
1 affected
33 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
39 events
21 affected
33 at risk
EG00441 events19 affected33 at risk
EG00514 events7 affected7 at risk
EG0064 events2 affected2 at risk
44 events
21 affected
33 at risk
EG00442 events21 affected33 at risk
EG0059 events6 affected7 at risk
EG0068 events2 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0042 events2 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0052 events1 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0043 events3 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
1 events
1 affected
33 at risk
EG0042 events2 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
6 events
5 affected
33 at risk
EG0044 events4 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0041 events1 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
1 events
1 affected
33 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
1 events
1 affected
33 at risk
EG0042 events2 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0042 events2 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected33 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
23
OG00420
OG0056
OG0062
Grade 2
OG0000
OG0010
OG0029
OG0034
OG0046
OG0050
OG0060
Grade 3
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00431
ParticipantsOG0057
ParticipantsOG0062
Title
Measurements
Grade 1
OG0001
OG0010
OG0028
OG0038
OG0048
OG0052
OG0060
Grade 2
OG0000
OG0010
OG00219
OG00312
OG004
Grade 3
OG0000
OG0010
OG00219
OG0039
OG004
2.4
± 0.70
OG0051.8± 0.75
OG0061.0± 0.00
ParticipantsOG00431
ParticipantsOG0057
ParticipantsOG0062
Title
Measurements
OG0001.0± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0024.4± 5.06
OG0034.1± 2.58
OG0044.3± 3.10
OG0055.4± 4.83
OG0063.0± 1.41
5
OG0047
OG0051
OG0061
10
OG0051
OG0060
1
OG0051
OG0060
0
OG0040
OG0050
OG0060
0
OG0040
OG0050
OG0060
7
OG0043
OG0051
OG0060
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0010
OG0026
OG0031
OG0042
OG0051
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
153.351
± 5.6201
OG004104.230± 5.4583
OG00590.306± 3.7506
OG00650.000± 1.0000
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG00150.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0021861.522± 7.3966
OG003179.992± 6.1193
OG004174.749± 1.1589
OG005554.010± NAStandard deviation could not be calculated as a single participant was analyzed.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
2
OG0041
OG0050
OG0060
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0010
OG0022
OG0030
OG0041
OG0050
7.297
± 2.3521
OG0046.234± 2.0782
OG0055.000± 1.0000
OG0065.000± 1.0000
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG0015.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG00226.389± 7.0380
OG0035.000± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0047.071± 1.6325
OG0055.000± NAStandard deviation could not be calculated as a single participant was analyzed.