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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2020-004070-22
    Trial protocol
    		 BE  
    Global end of trial date
    21 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Apr 2022
    First version publication date
    30 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CV-NCOV-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04860258
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CureVac AG
    Sponsor organisation address
    Schumannstrasse 27, Frankfurt, Germany, 60325
    Public contact
    Clinical Trial Information, CureVac AG, 0049 6976805870, clinicaltrials@curevac.com
    Scientific contact
    Clinical Trial Information, CureVac AG, 0049 6976805870, clinicaltrials@curevac.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccine (CVnCoV). • To evaluate the humoral immune responses 14 days after 2 dose administrations of CVnCoV.
    Protection of trial subjects
    This trial was conducted with the highest respect for the individual participants in compliance with the requirements of this clinical trial protocol (and amendments), and also in compliance with the following: • The ethical principles that have their origin in the Declaration of Helsinki. • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E6 (R2) Good Clinical Practice: Revised and consolidated guidelines. • All applicable laws and regulations, including, without limitation, data privacy laws, clinical trial disclosure laws, and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 129
    Worldwide total number of subjects
    129
    EEA total number of subjects
    129
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    114
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was performed in Belgium between 22 April 2021 and 21 September 2021.

    Pre-assignment
    Screening 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 SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chronic Kidney Disease
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVnCoV Vaccine
    Investigational medicinal product code
    CV07050101
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM) injection in the deltoid area, preferably in the nondominant arm.

    Arm title
    		 Chronic Obstructive Pulmonary Disease (COPD)
    Arm description
    		 Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVnCoV Vaccine
    Investigational medicinal product code
    CV07050101
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection in the deltoid area, preferably in the nondominant arm.

    Arm title
    		 Obesity
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVnCoV Vaccine
    Investigational medicinal product code
    CV07050101
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection in the deltoid area, preferably in the nondominant arm.

    Arm title
    		 Chronic Cardiovascular Disease
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVnCoV Vaccine
    Investigational medicinal product code
    CV07050101
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection in the deltoid area, preferably in the nondominant arm.

    Arm title
    		 Chronic Human Immunodeficiency Virus (HIV) Infection
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVnCoV Vaccine
    Investigational medicinal product code
    CV07050101
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection in the deltoid area, preferably in the nondominant arm.

    Arm title
    		 Type 2 Diabetes Mellitus
    Arm description
    		 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%)].
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVnCoV Vaccine
    Investigational medicinal product code
    CV07050101
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection in the deltoid area, preferably in the nondominant arm.

    Arm title
    		 Renal Transplant
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVnCoV Vaccine
    Investigational medicinal product code
    CV07050101
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection in the deltoid area, preferably in the nondominant arm.

    Number of subjects in period 1
    		Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Started
    1
    1
    52
    33
    33
    7
    2
    Completed
    1
    1
    48
    32
    29
    6
    2
    Not completed
    0
    0
    4
    1
    4
    1
    0
         Consent withdrawn by subject
    -
    -
    4
    1
    4
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 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.

    Reporting group title
    Chronic Obstructive Pulmonary Disease (COPD)
    Reporting group description
    		 Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.

    Reporting group title
    Obesity
    Reporting group description
    		 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.

    Reporting group title
    Chronic Cardiovascular Disease
    Reporting group description
    		 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.

    Reporting group title
    Chronic Human Immunodeficiency Virus (HIV) Infection
    Reporting group description
    		 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.

    Reporting group title
    Type 2 Diabetes Mellitus
    Reporting group description
    		 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%)].

    Reporting group title
    Renal Transplant
    Reporting group description
    		 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.

    Reporting group values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant Total
    Number of subjects
    		 1 1 52 33 33 7 2 129
    Age categorical
    Units: Subjects
    Age continuous
    Values of '99999' indicate standard deviation could not be calculated as a single participant was analyzed.
    Units: years
        arithmetic mean (standard deviation)
    		 54.0 ( 99999 ) 73.0 ( 99999 ) 42.7 ( 10.77 ) 52.3 ( 12.36 ) 43.7 ( 11.69 ) 58.3 ( 9.21 ) 39.0 ( 2.83 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 23 7 4 3 0 37
        Male
    		 1 1 29 26 29 4 2 92
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 1 0 0 1
        Not Hispanic or Latino
    		 1 1 49 33 32 7 2 125
        Unknown or Not Reported
    		 0 0 3 0 0 0 0 3
    Race
    Units: Subjects
        White
    		 1 1 48 30 25 7 2 114
        Black or African American
    		 0 0 2 3 3 0 0 8
        Asian
    		 0 0 0 0 0 0 0 0
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0
        Other
    		 0 0 1 0 5 0 0 6
        Not Reported
    		 0 0 0 0 0 0 0 0
        Unknown
    		 0 0 1 0 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 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.

    Reporting group title
    Chronic Obstructive Pulmonary Disease (COPD)
    Reporting group description
    		 Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.

    Reporting group title
    Obesity
    Reporting group description
    		 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.

    Reporting group title
    Chronic Cardiovascular Disease
    Reporting group description
    		 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.

    Reporting group title
    Chronic Human Immunodeficiency Virus (HIV) Infection
    Reporting group description
    		 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.

    Reporting group title
    Type 2 Diabetes Mellitus
    Reporting group description
    		 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%)].

    Reporting group title
    Renal Transplant
    Reporting group description
    		 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.

    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

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    End point title
    		 Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose [1]
    End point description
    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 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. Values of "99999" indicate standard deviation could not be calculated as a single participant was analyzed.
    End point type
    Primary
    End point timeframe
    Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    52
    33
    33
    7
    2
    Units: participants
        Any solicited local AEs
    1
    1
    40
    28
    26
    6
    2
        Any solicited systemic AEs
    1
    1
    46
    29
    31
    7
    2
        Any related solicited systemic AEs
    0
    0
    44
    26
    28
    6
    2
    No statistical analyses for this end point

    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

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    End point title
    		 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 [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    0 [3]
    46 [4]
    29 [5]
    31 [6]
    7 [7]
    2
    Units: participants
        Any solicited local AEs: Grade 1
    1
    30
    23
    20
    6
    2
        Any solicited local AEs: Grade 2
    0
    9
    4
    6
    0
    0
        Any solicited local AEs: Grade 3
    0
    1
    1
    0
    0
    0
        Any solicited systemic AEs: Grade 1
    1
    8
    8
    8
    2
    0
        Any solicited systemic AEs: Grade 2
    0
    19
    12
    14
    3
    2
        Any solicited systemic AEs: Grade 3
    0
    19
    9
    9
    2
    0
    Notes
    [3] - No participants in the SAS experienced a solicited local or systemic AE.
    [4] - Solicited local AE n = 40.
    [5] - Solicited local AE n = 28.
    [6] - Solicited local AE n = 26.
    [7] - Solicited local AE n = 6. Solicited systemic AE n = 7.
    No statistical analyses for this end point

    Primary: Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose

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    End point title
    		 Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose [8]
    End point description
    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. Values of "99999" indicate standard deviation could not be calculated as a single participant was analyzed.
    End point type
    Primary
    End point timeframe
    Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    0 [9]
    46 [10]
    29 [11]
    31 [12]
    7 [13]
    2
    Units: days
    arithmetic mean (standard deviation)
        Any solicited local AEs
    1.0 ( 99999 )
    ( )
    2.2 ( 1.11 )
    2.1 ( 1.21 )
    2.4 ( 0.70 )
    1.8 ( 0.75 )
    1.0 ( 0.00 )
        Any solicited systemic AEs
    1.0 ( 99999 )
    ( )
    4.4 ( 5.06 )
    4.1 ( 2.58 )
    4.3 ( 3.10 )
    5.4 ( 4.83 )
    3.0 ( 1.41 )
    Notes
    [9] - No solicited AEs were reported.
    [10] - Any solicited local AEs n = 40.
    [11] - Any solicited local AEs n = 28.
    [12] - Any solicited local AEs n = 26.
    [13] - Any solicited local AEs n = 6.
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose

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    End point title
    		 Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose [14]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    52
    33
    33
    7
    2
    Units: participants
        Any unsolicited AEs
    1
    1
    27
    14
    19
    4
    1
        Any related unsolicited AEs
    1
    1
    12
    5
    7
    1
    1
    No statistical analyses for this end point

    Primary: Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose

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    End point title
    		 Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose [15]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    27
    14
    19
    4
    1
    Units: participants
        Mild
    1
    0
    6
    4
    8
    2
    1
        Moderate
    0
    1
    17
    7
    10
    1
    0
        Severe
    0
    0
    4
    3
    1
    1
    0
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial

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    End point title
    		 Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial [16]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to Day 57
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    52
    33
    33
    7
    2
    Units: participants
        Any SAEs
    0
    0
    0
    0
    0
    1
    0
        Any related SAEs
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial

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    End point title
    		 Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial [17]
    End point description
    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 also 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.
    End point type
    Primary
    End point timeframe
    Up to Day 57
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    52
    33
    33
    7
    2
    Units: participants
        Any AESIs
    0
    0
    2
    1
    1
    0
    0
        Any Related AESIs
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43

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    End point title
    		 Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 [18]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Baseline and Day 43
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    38
    21
    18
    5
    2
    Units: count of seroconverted participants
    1
    0
    34
    19
    16
    4
    1
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43

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    End point title
    		 Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 [19]
    End point description
    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. Values of "99999" indicate standard deviation could not be calculated as a single participant was analyzed.
    End point type
    Primary
    End point timeframe
    Day 43
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    38
    21
    18
    5
    2
    Units: titers
        geometric mean (standard deviation)
    518.410 ( 99999 )
    50.000 ( 99999 )
    1576.121 ( 7.5115 )
    1385.663 ( 5.8935 )
    968.795 ( 4.7759 )
    183.523 ( 2.4423 )
    416.051 ( 20.0136 )
    No statistical analyses for this end point

    Primary: Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43

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    End point title
    		 Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 [20]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Baseline and Day 43
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    23
    11
    11
    5
    2
    Units: count of seroconverted participants
    1
    0
    16
    6
    7
    0
    1
    No statistical analyses for this end point

    Primary: Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43

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    End point title
    		 Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 [21]
    End point description
    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. Values of "99999" indicate standard deviation could not be calculated as a single participant was analyzed.
    End point type
    Primary
    End point timeframe
    Day 43
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    23
    11
    11
    5
    2
    Units: titers
        geometric mean (standard deviation)
    14.140 ( 99999 )
    5.000 ( 99999 )
    57.426 ( 9.1427 )
    16.042 ( 4.0790 )
    18.778 ( 3.9937 )
    5.000 ( 1.0000 )
    10.000 ( 2.6651 )
    No statistical analyses for this end point

    Secondary: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393

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    End point title
    		 Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
    End point description
    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 analysis population was the PPI. No data was collected for Days 211 and 393 due to early study termination. Values of "9999" indicate no participants were analyzed at that timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 29, 120, 211 and 393
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    39
    21
    18
    5
    2
    Units: count of seroconverted participants
        Day 29 (n = 1, 1, 39, 21, 18, 5, 2)
    0
    0
    13
    7
    3
    1
    0
        Day 120 (n = 0, 1, 7, 2, 2, 1, 0)
    9999
    0
    6
    1
    2
    1
    9999
        Day 211 (n = 0, 0, 0, 0, 0, 0, 0)
    9999
    9999
    9999
    9999
    9999
    9999
    9999
        Day 393 (n = 0, 0, 0, 0, 0, 0, 0)
    9999
    9999
    9999
    9999
    9999
    9999
    9999
    No statistical analyses for this end point

    Secondary: GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393

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    End point title
    		 GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
    End point description
    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 analysis population was the PPI. No data was collected for Days 211 and 393 due to early study termination. Values of "9999" indicate no participants were analyzed at that timepoint and values of "99999" indicate standard deviation could not be calculated as a single participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Days 29, 120, 211 and 393
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    39
    21
    18
    5
    2
    Units: titers
    geometric mean (standard deviation)
        Day 29 (n = 1, 1, 39, 21, 18, 5, 2)
    50.000 ( 99999 )
    50.000 ( 99999 )
    234.464 ( 9.4598 )
    153.351 ( 5.6201 )
    104.230 ( 5.4583 )
    90.306 ( 3.7506 )
    50.000 ( 1.0000 )
        Day 120 (n = 0, 1, 7, 2, 2, 1, 0)
    9999 ( 9999 )
    50.000 ( 99999 )
    1861.522 ( 7.3966 )
    179.992 ( 6.1193 )
    174.749 ( 1.1589 )
    554.010 ( 99999 )
    9999 ( 9999 )
        Day 211 (n = 0, 0, 0, 0, 0, 0, 0)
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
        Day 393 (n = 0, 0, 0, 0, 0, 0, 0)
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    No statistical analyses for this end point

    Secondary: Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120

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    End point title
    		 Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
    End point description
    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. Values of "9999" indicate no participants were analyzed at that timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 29 and 120
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    24
    11
    11
    5
    2
    Units: count of seroconverted participants
        Day 29 (n = 1, 1, 24, 11, 11, 5, 2)
    0
    0
    7
    2
    1
    0
    0
        Day 120 (n = 0, 1, 5, 1, 2, 1, 0)
    9999
    0
    2
    0
    1
    0
    9999
    No statistical analyses for this end point

    Secondary: Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120

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    End point title
    		 Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
    End point description
    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. Values of "9999" indicate no participants were analyzed at that timepoint and values of "99999" indicate standard deviation could not be calculated as a single participant was analyzed.
    End point type
    Secondary
    End point timeframe
    Days 29 and 120
    End point values
    		 Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Obesity Chronic Cardiovascular Disease Chronic Human Immunodeficiency Virus (HIV) Infection Type 2 Diabetes Mellitus Renal Transplant
    Number of subjects analysed
    1
    1
    24
    11
    11
    5
    2
    Units: titers
    geometric mean (standard deviation)
        Day 29 (n = 1, 1, 24, 11, 11, 5, 2)
    5.000 ( 99999 )
    5.000 ( 99999 )
    17.311 ( 7.4073 )
    7.297 ( 2.3521 )
    6.234 ( 2.0782 )
    5.000 ( 1.0000 )
    5.000 ( 1.0000 )
        Day 120 (n = 0, 1, 5, 1, 2, 1, 0)
    9999 ( 9999 )
    5.000 ( 99999 )
    26.389 ( 7.0380 )
    5.000 ( 99999 )
    7.071 ( 1.6325 )
    5.000 ( 99999 )
    9999 ( 9999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 57
    Adverse event reporting additional 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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    COPD
    Reporting group description
    		 Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.

    Reporting group title
    Chronic Kidney Disease
    Reporting group description
    		 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.

    Reporting group title
    Chronic HIV Infection
    Reporting group description
    		 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.

    Reporting group title
    Type 2 Diabetes Mellitus
    Reporting group description
    		 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%)].

    Reporting group title
    Renal Transplant
    Reporting group description
    		 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.

    Reporting group title
    Obesity
    Reporting group description
    		 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.

    Reporting group title
    Chronic Cardiovascular Disease
    Reporting group description
    		 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.

    Serious adverse events
    		 COPD Chronic Kidney Disease Chronic HIV Infection Type 2 Diabetes Mellitus Renal Transplant Obesity Chronic Cardiovascular Disease
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Empyema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 COPD Chronic Kidney Disease Chronic HIV Infection Type 2 Diabetes Mellitus Renal Transplant Obesity Chronic Cardiovascular Disease
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    33 / 33 (100.00%)
    7 / 7 (100.00%)
    2 / 2 (100.00%)
    50 / 52 (96.15%)
    32 / 33 (96.97%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 33 (3.03%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    14 / 33 (42.42%)
    1 / 7 (14.29%)
    1 / 2 (50.00%)
    24 / 52 (46.15%)
    20 / 33 (60.61%)
         occurrences all number
    0
    2
    23
    1
    2
    34
    23
    Fatigue
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    22 / 33 (66.67%)
    7 / 7 (100.00%)
    2 / 2 (100.00%)
    44 / 52 (84.62%)
    25 / 33 (75.76%)
         occurrences all number
    0
    0
    58
    15
    10
    142
    56
    Feeling abnormal
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    27 / 33 (81.82%)
    6 / 7 (85.71%)
    2 / 2 (100.00%)
    39 / 52 (75.00%)
    27 / 33 (81.82%)
         occurrences all number
    0
    1
    41
    8
    3
    59
    40
    Pyrexia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    6 / 33 (18.18%)
    2 / 7 (28.57%)
    1 / 2 (50.00%)
    14 / 52 (26.92%)
    10 / 33 (30.30%)
         occurrences all number
    0
    0
    8
    2
    2
    20
    11
    Swelling
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    4 / 52 (7.69%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    4
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    2
    Malaise
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 33 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    3 / 52 (5.77%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    5
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    2 / 52 (3.85%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    2
    0
    Nasal congestion
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 33 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    21 / 33 (63.64%)
    6 / 7 (85.71%)
    2 / 2 (100.00%)
    39 / 52 (75.00%)
    21 / 33 (63.64%)
         occurrences all number
    0
    0
    42
    9
    8
    106
    44
    Parosmia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Taste disorder
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 33 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    9 / 33 (27.27%)
    3 / 7 (42.86%)
    0 / 2 (0.00%)
    26 / 52 (50.00%)
    11 / 33 (33.33%)
         occurrences all number
    0
    0
    17
    3
    0
    56
    18
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    10 / 33 (30.30%)
    2 / 7 (28.57%)
    1 / 2 (50.00%)
    9 / 52 (17.31%)
    6 / 33 (18.18%)
         occurrences all number
    0
    0
    14
    2
    2
    11
    6
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    2 / 52 (3.85%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    1
    Pruritus
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 33 (12.12%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    5 / 52 (9.62%)
    5 / 33 (15.15%)
         occurrences all number
    0
    0
    4
    0
    0
    5
    6
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    9 / 33 (27.27%)
    6 / 7 (85.71%)
    1 / 2 (50.00%)
    27 / 52 (51.92%)
    15 / 33 (45.45%)
         occurrences all number
    0
    1
    16
    15
    2
    54
    31
    Limb discomfort
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    3 / 52 (5.77%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    Myalgia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    19 / 33 (57.58%)
    7 / 7 (100.00%)
    2 / 2 (100.00%)
    35 / 52 (67.31%)
    21 / 33 (63.64%)
         occurrences all number
    0
    1
    41
    14
    4
    68
    39
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Syphilis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 33 (9.09%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    1 / 52 (1.92%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    COVID-19
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 33 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    3 / 52 (5.77%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    Pharyngitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 33 (6.06%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 52 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jul 2021
    Participants who had already received at least 1 CVnCoV dose were asked to remain in the trial for 3 months following their last CVnCoV dose for safety and immunogenicity follow-up. No immunogenicity samples were to be taken after a participant received their first dose of an authorized/licensed COVID-19 vaccine. Sites were to follow the amended Schedule of Activities until the participant reached 3 months of follow-up post last dose of CVnCoV. The follow-up period, including Visit 9/Day 211 and Phone Contact/Day 302, was removed. The timing of the End-of-trial Visit/Day 393 was amended to 3 months post last injection of CVnCoV. Any participants that were in screening at the time of decision taking were considered screen failures and were not to receive CVnCoV vaccination in line with the enrollment halt. No additional screenings were to be performed. Participants were provided with adequate information about the changes to the trial, in accordance with applicable local regulations and in line with the protocol Section 12.4 “Informed Consent.”

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Jun 2021
    During the trial conduct, a decision was taken to stop further recruitment and place vaccination on hold from 18 June 2021 due to the efficacy results from the pivotal Phase 2b/3 trial CV-NCOV-004 and amend the protocol version 2.0 to clarify that all participants should undergo safety and immunogenicity follow-up for 3 months following the last CVnCoV dose.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    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.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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