Coronavirus, COVID-19, SARS-CoV-2, Severe Acute Respiratory Syndrome
Conditions
Keywords
Safety, Reactogenicity, Immunogenicity, Vaccine, CEPI
Brief summary
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
Detailed description
Funded by Coalition for Epidemic Preparedness Innovations (CEPI). 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.).
Interventions
DRUGPlacebo
Participants will receive an intramuscular injection by needle in the deltoid area.
BIOLOGICALCVnCoV Vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.
Sponsors
Coalition for Epidemic Preparedness Innovations
CureVac
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
In the initial part of the dose escalation, participants will be enrolled in sentinel groups in an open manner. In the second part, participants will be enrolled in placebo-controlled groups in an observer-blind manner.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
for all participants: * Healthy male and female participants aged 18 to 60 years inclusive. Healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication. * Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. * Physical examination and laboratory results without clinically significant findings according to the Investigator's assessment. * Body Mass Index (BMI) ≥18.0 and ≤30.0kg/m\^2 (≥18.0 and ≤32.0kg/m2 for participants with SARS-CoV-2 positive serology). * Females: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if the serum pregnancy test was performed more than 3 days before). * Females of childbearing potential must use highly effective methods of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); * Intrauterine devices (IUDs); * Intrauterine hormone-releasing systems (IUSs); * Bilateral tubal occlusion; * Vasectomized partner; * Sexual abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable).
Exclusion criteria
The following criterion applies to all open-label sentinel participants: * Participants with SARS-CoV-2 positive serology as confirmed by testing at enrollment. The following criteria apply to all participants, except those with SARS-CoV-2 positive serology: * Participants considered at the Investigator's discretion to be at increased risk to acquire COVID-19 disease (including, but not limited to, health care workers with direct involvement in patient care or care of long-term care recipients). * History of confirmed COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks. The following criteria apply to all participants: * 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 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. * Receipt of any investigational SARS-CoV-2 or other CoV vaccine prior to the administration of the trial vaccine. * Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied steroids. Corticosteroids used in the context of COVID-19 disease of participants with SARS CoV 2 positive serology are not exclusionary. * Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection and hepatitis C virus infection. * History of a pIMD (potential immune-mediated disease). * History of angioedema. * Any known allergy, including allergy to any component of CVnCoV or aminoglycoside antibiotics. A history of hay fever or seasonal allergies (pollinosis) that does not require current treatment (e.g., anti-histamines) during the vaccination period (1 month before first vaccination until 1 month after last vaccination) is not exclusionary. * History of or current alcohol and/or drug abuse. * Participants who are active smokers, were active smokers within the last year (including any vaping in the last year) or have a total smoking history ≥10 pack years. * Active or currently active SARS-CoV-2 infection as confirmed by reactive PCR within 3 days of first trial vaccine administration. * History of confirmed SARS or MERS * Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine. * Presence or evidence of significant acute or chronic, medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to: * Respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. * Respiratory disease with clinically significant dyspnea in the last 5 years (except COVID-19 disease in participants with SARS-CoV-2 positive serology). * Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long- and short-acting beta agonists, theophylline, ipratropium, biologics. * Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery disease, pulmonary embolism) or history of myocarditis or pericarditis as an adult. * Elevated blood pressure or hypertension, even if well-controlled. * Diabetes mellitus type 1 or 2. * History of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of 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 females: pregnancy or lactation. * History of any anaphylactic reactions. * Participants with impaired coagulation or any bleeding disorder in whom an IM injection or a blood draw is contraindicated. * Participants employed by the Sponsor, Investigator or trial site, or relatives of research staff working on this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Adverse Events of Special Interest (AESIs) | Day 1 to Day 393 | The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease. |
| Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Number of Participants With Unsolicited Adverse Events | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) | 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. |
| Intensity of Unsolicited Adverse Events Assessed by the Investigator | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) | 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. |
| Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) | 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. |
| Number of Participants With One or More Serious Adverse Events (SAEs) | Baseline to Day 393 | 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. |
| Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | Baseline to Day 393 | 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. |
| Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Up to 24 hours after vaccination on Day 1 | Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. 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. |
| Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Up to 60 hours after vaccination on Day 1 | Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. 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. |
| Number of Participants With Solicited Local Adverse Events | Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36) | Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. |
| Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) 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. |
| Duration of Solicited Local Adverse Events | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. |
| Number of Participants With Solicited Systemic Adverse Events | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. |
| Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of 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. |
| Duration of Solicited Systemic Adverse Events | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. |
| Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). |
| Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. |
| Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). |
| Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 | Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. |
| Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 | Measured using an activity assay. |
Countries
Belgium, Germany
Participant flow
Recruitment details
This trial was performed in Belgium and Germany between June 2020 and December 2021.
Pre-assignment details
Of the 408 participants who were screened, 280 participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Dose Escalation CVnCoV: 2 µg Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area. | 47 |
| Dose Escalation CVnCoV: 4 µg Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area. | 48 |
| Dose Escalation CVnCoV: 6 µg Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area. | 48 |
| Dose Escalation CVnCoV: 8 µg Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area. | 49 |
| Dose Escalation CVnCoV: 12 µg Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area. | 28 |
| Dose Escalation CVnCoV: 16 µg Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area. | 16 |
| Dose Escalation CVnCoV: 20 µg Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area. | 12 |
| Dose Escalation Placebo Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area. | 32 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 0 | 0 | 2 | 0 | 0 | 1 |
| Overall Study | Other | 0 | 2 | 3 | 2 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Dose Escalation CVnCoV: 4 µg | Dose Escalation CVnCoV: 6 µg | Dose Escalation CVnCoV: 8 µg | Dose Escalation CVnCoV: 12 µg | Dose Escalation CVnCoV: 2 µg | Dose Escalation CVnCoV: 16 µg | Dose Escalation CVnCoV: 20 µg | Dose Escalation Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.1 years STANDARD_DEVIATION 13.17 | 38.6 years STANDARD_DEVIATION 12.74 | 38.9 years STANDARD_DEVIATION 12.87 | 37.4 years STANDARD_DEVIATION 13.51 | 38.2 years STANDARD_DEVIATION 12.48 | 37.4 years STANDARD_DEVIATION 13.89 | 39.3 years STANDARD_DEVIATION 12.11 | 40.1 years STANDARD_DEVIATION 13.46 | 38.7 years STANDARD_DEVIATION 12.85 |
| Age, Customized 18 - 40 years | 24 Participants | 24 Participants | 24 Participants | 17 Participants | 24 Participants | 10 Participants | 6 Participants | 16 Participants | 145 Participants |
| Age, Customized 41 - 60 years | 24 Participants | 24 Participants | 25 Participants | 11 Participants | 23 Participants | 6 Participants | 6 Participants | 16 Participants | 135 Participants |
| Baseline Immunestatus Seronegative | 40 Participants | 40 Participants | 38 Participants | 24 Participants | 39 Participants | 12 Participants | 12 Participants | 24 Participants | 229 Participants |
| Baseline Immunestatus Seropositive | 8 Participants | 8 Participants | 11 Participants | 4 Participants | 8 Participants | 4 Participants | 0 Participants | 8 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 46 Participants | 49 Participants | 27 Participants | 44 Participants | 16 Participants | 11 Participants | 32 Participants | 273 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 48 Participants | 44 Participants | 47 Participants | 28 Participants | 43 Participants | 16 Participants | 12 Participants | 31 Participants | 269 Participants |
| Region of Enrollment Belgium | 18 Participants | 10 Participants | 4 Participants | 3 Participants | 13 Participants | 4 Participants | 4 Participants | 6 Participants | 62 Participants |
| Region of Enrollment Germany | 30 Participants | 38 Participants | 45 Participants | 25 Participants | 34 Participants | 12 Participants | 8 Participants | 26 Participants | 218 Participants |
| Sex: Female, Male Female | 23 Participants | 17 Participants | 18 Participants | 11 Participants | 20 Participants | 4 Participants | 5 Participants | 17 Participants | 115 Participants |
| Sex: Female, Male Male | 25 Participants | 31 Participants | 31 Participants | 17 Participants | 27 Participants | 12 Participants | 7 Participants | 15 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 48 | 0 / 48 | 0 / 49 | 0 / 28 | 0 / 16 | 0 / 12 | 0 / 32 |
| other Total, other adverse events | 23 / 47 | 28 / 48 | 26 / 48 | 25 / 49 | 22 / 28 | 14 / 16 | 12 / 12 | 17 / 32 |
| serious Total, serious adverse events | 2 / 47 | 0 / 48 | 1 / 48 | 1 / 49 | 2 / 28 | 0 / 16 | 0 / 12 | 1 / 32 |
Outcome results
Primary
Duration of Solicited Local Adverse Events
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: Only participants who experienced solicited local AEs were used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Duration of Solicited Local Adverse Events | 1.8 days | Standard Deviation 0.99 |
| Dose Escalation CVnCoV: 4 µg | Duration of Solicited Local Adverse Events | 2.0 days | Standard Deviation 0.84 |
| Dose Escalation CVnCoV: 6 µg | Duration of Solicited Local Adverse Events | 2.3 days | Standard Deviation 1.02 |
| Dose Escalation CVnCoV: 8 µg | Duration of Solicited Local Adverse Events | 2.4 days | Standard Deviation 1.44 |
| Dose Escalation CVnCoV: 12 µg | Duration of Solicited Local Adverse Events | 2.6 days | Standard Deviation 1.44 |
| Dose Escalation CVnCoV: 16 µg | Duration of Solicited Local Adverse Events | 2.5 days | Standard Deviation 0.82 |
| Dose Escalation CVnCoV: 20 µg | Duration of Solicited Local Adverse Events | 3.0 days | Standard Deviation 1.18 |
| Dose Escalation Placebo | Duration of Solicited Local Adverse Events | 1.2 days | Standard Deviation 0.45 |
Primary
Duration of Solicited Systemic Adverse Events
Reactogenicity was assessed daily via collection of 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.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: Only participants who experienced solicited systemic AEs were used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Duration of Solicited Systemic Adverse Events | 3.1 days | Standard Deviation 5.38 |
| Dose Escalation CVnCoV: 4 µg | Duration of Solicited Systemic Adverse Events | 2.1 days | Standard Deviation 1.15 |
| Dose Escalation CVnCoV: 6 µg | Duration of Solicited Systemic Adverse Events | 2.4 days | Standard Deviation 2.16 |
| Dose Escalation CVnCoV: 8 µg | Duration of Solicited Systemic Adverse Events | 3.2 days | Standard Deviation 2.4 |
| Dose Escalation CVnCoV: 12 µg | Duration of Solicited Systemic Adverse Events | 3.6 days | Standard Deviation 1.73 |
| Dose Escalation CVnCoV: 16 µg | Duration of Solicited Systemic Adverse Events | 2.5 days | Standard Deviation 0.73 |
| Dose Escalation CVnCoV: 20 µg | Duration of Solicited Systemic Adverse Events | 3.4 days | Standard Deviation 1.24 |
| Dose Escalation Placebo | Duration of Solicited Systemic Adverse Events | 1.8 days | Standard Deviation 0.96 |
Primary
Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) 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.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 2 Participants |
| Dose Escalation CVnCoV: 2 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 30 Participants |
| Dose Escalation CVnCoV: 2 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 0 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 3 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 1 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 39 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 1 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 32 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 5 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 1 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 29 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 11 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 17 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 9 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 0 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 12 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 4 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 5 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 6 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 0 Participants |
| Dose Escalation Placebo | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 5 Participants |
| Dose Escalation Placebo | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 0 Participants |
| Dose Escalation Placebo | Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 0 Participants |
Primary
Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale
Reactogenicity was assessed daily via collection of 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.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 5 Participants |
| Dose Escalation CVnCoV: 2 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 21 Participants |
| Dose Escalation CVnCoV: 2 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 3 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 9 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 14 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 22 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 20 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 16 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 8 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 14 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 11 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 20 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 11 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 16 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 1 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 7 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 2 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 7 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 5 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 7 Participants |
| Dose Escalation Placebo | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 1 | 15 Participants |
| Dose Escalation Placebo | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 2 | 4 Participants |
| Dose Escalation Placebo | Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale | Grade 3 | 0 Participants |
Primary
Intensity of Unsolicited Adverse Events Assessed by the Investigator
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.
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of mild, moderate, and severe adverse events in the entire analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 14 Participants |
| Dose Escalation CVnCoV: 2 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 2 Participants |
| Dose Escalation CVnCoV: 2 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 10 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 2 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 13 Participants |
| Dose Escalation CVnCoV: 4 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 17 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 4 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 15 Participants |
| Dose Escalation CVnCoV: 6 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 10 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 12 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 17 Participants |
| Dose Escalation CVnCoV: 8 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 2 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 10 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 9 Participants |
| Dose Escalation CVnCoV: 12 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 4 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 5 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 8 Participants |
| Dose Escalation CVnCoV: 16 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 2 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 4 Participants |
| Dose Escalation CVnCoV: 20 µg | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 5 Participants |
| Dose Escalation Placebo | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Mild | 9 Participants |
| Dose Escalation Placebo | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Moderate | 6 Participants |
| Dose Escalation Placebo | Intensity of Unsolicited Adverse Events Assessed by the Investigator | Severe | 1 Participants |
Primary
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. 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.
Time frame: Up to 24 hours after vaccination on Day 1
Population: Only participants with available data were used for this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 3 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 9 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 8 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 14 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 12 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 7 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 8 Participants |
| Dose Escalation Placebo | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 0 Participants |
| Dose Escalation Placebo | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
Primary
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. 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.
Time frame: Up to 60 hours after vaccination on Day 1
Population: Only participants with available data were used for this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 3 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 9 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 8 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 14 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 12 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 7 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 8 Participants |
| Dose Escalation Placebo | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Grade 3 Adverse Reaction | 0 Participants |
| Dose Escalation Placebo | Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination | Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine | 0 Participants |
Primary
Number of Participants With One or More Adverse Events of Special Interest (AESIs)
The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.
Time frame: Day 1 to Day 393
Population: Only participants with available data were used for this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 1 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 0 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 2 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 1 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 1 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 1 Participants |
| Dose Escalation Placebo | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | 1 Participants |
Primary
Number of Participants With One or More Serious Adverse Events (SAEs)
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.
Time frame: Baseline to Day 393
Population: Only participants with available data were used in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With One or More Serious Adverse Events (SAEs) | 2 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With One or More Serious Adverse Events (SAEs) | 0 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With One or More Serious Adverse Events (SAEs) | 1 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With One or More Serious Adverse Events (SAEs) | 1 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With One or More Serious Adverse Events (SAEs) | 2 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With One or More Serious Adverse Events (SAEs) | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With One or More Serious Adverse Events (SAEs) | 0 Participants |
| Dose Escalation Placebo | Number of Participants With One or More Serious Adverse Events (SAEs) | 1 Participants |
Primary
Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine
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.
Time frame: Baseline to Day 393
Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with one or more SAEs considered related to trial vaccine in the entire analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
| Dose Escalation Placebo | Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine | 0 Participants |
Primary
Number of Participants With Solicited Local Adverse Events
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)
Population: Only participants with available data were used for this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Solicited Local Adverse Events | 32 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Solicited Local Adverse Events | 43 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Solicited Local Adverse Events | 38 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Solicited Local Adverse Events | 41 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Solicited Local Adverse Events | 26 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Solicited Local Adverse Events | 16 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Solicited Local Adverse Events | 11 Participants |
| Dose Escalation Placebo | Number of Participants With Solicited Local Adverse Events | 5 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: Only participants with available data were used for this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Solicited Systemic Adverse Events | 29 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Solicited Systemic Adverse Events | 45 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Solicited Systemic Adverse Events | 44 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Solicited Systemic Adverse Events | 45 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Solicited Systemic Adverse Events | 28 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Solicited Systemic Adverse Events | 16 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Solicited Systemic Adverse Events | 12 Participants |
| Dose Escalation Placebo | Number of Participants With Solicited Systemic Adverse Events | 19 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with solicited adverse events considered related to trial vaccine in the entire analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 28 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 45 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 44 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 44 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 28 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 16 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 12 Participants |
| Dose Escalation Placebo | Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine | 17 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
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.
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Population: Only participants with available data were used for this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Unsolicited Adverse Events | 26 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Unsolicited Adverse Events | 32 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Unsolicited Adverse Events | 29 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Unsolicited Adverse Events | 31 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Unsolicited Adverse Events | 23 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Unsolicited Adverse Events | 13 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Unsolicited Adverse Events | 11 Participants |
| Dose Escalation Placebo | Number of Participants With Unsolicited Adverse Events | 16 Participants |
Primary
Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine
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.
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with unsolicited adverse events considered related to trial vaccine in the entire analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 7 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 20 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 15 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 16 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 12 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 4 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 10 Participants |
| Dose Escalation Placebo | Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine | 5 Participants |
Secondary
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Measured using an activity assay.
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Population: The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 13.419 titers | Standard Deviation 2.9626 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 7.001 titers | Standard Deviation 2.3126 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 6.547 titers | Standard Deviation 1.6565 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 12.240 titers | Standard Deviation 3.2214 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 41.664 titers | Standard Deviation 5.0333 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 33.813 titers | Standard Deviation 4.023 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 11.892 titers | Standard Deviation 3.224 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 7.564 titers | Standard Deviation 2.0377 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 5.191 titers | Standard Deviation 1.256 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 9.247 titers | Standard Deviation 2.8688 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 17.340 titers | Standard Deviation 4.0855 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 5.095 titers | Standard Deviation 1.1207 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 11.107 titers | Standard Deviation 4.0813 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 13.577 titers | Standard Deviation 3.1691 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 5.106 titers | Standard Deviation 1.1282 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 8.369 titers | Standard Deviation 2.2413 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 13.348 titers | Standard Deviation 3.0155 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 26.696 titers | Standard Deviation 4.2447 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 8.042 titers | Standard Deviation 2.3671 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 26.336 titers | Standard Deviation 3.9767 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 5.221 titers | Standard Deviation 1.1859 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 51.086 titers | Standard Deviation 3.5503 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 8.269 titers | Standard Deviation 2.3683 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 11.462 titers | Standard Deviation 2.2848 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 8.086 titers | Standard Deviation 1.973 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 49.044 titers | Standard Deviation 3.1527 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 22.224 titers | Standard Deviation 2.9539 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 52.462 titers | Standard Deviation 3.4275 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 24.786 titers | Standard Deviation 2.9671 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 14.366 titers | Standard Deviation 3.1876 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 6.234 titers | Standard Deviation 1.6616 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 28.284 titers | Standard Deviation 3.0577 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 33.108 titers | Standard Deviation 3.2347 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 14.142 titers | Standard Deviation 3.0248 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 5.496 titers | Standard Deviation 1.3681 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 20.640 titers | Standard Deviation 5.0609 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 5.325 titers | Standard Deviation 1.2324 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 10.905 titers | Standard Deviation 7.3473 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 49.869 titers | Standard Deviation 4.5037 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 8.170 titers | Standard Deviation 5.4783 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 38.860 titers | Standard Deviation 6.769 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 96.647 titers | Standard Deviation 7.8329 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 9.715 titers | Standard Deviation 6.7304 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 119.865 titers | Standard Deviation 6.8222 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 11.487 titers | Standard Deviation 4.3194 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 43 | 6.050 titers | Standard Deviation 1.8413 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 29 | 5.160 titers | Standard Deviation 1.1593 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 57 | 5.612 titers | Standard Deviation 1.4462 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 15 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 120 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 8 | 5.242 titers | Standard Deviation 1.2481 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 211 | 5.000 titers | Standard Deviation 1 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Day 36 | 5.430 titers | Standard Deviation 1.3051 |
Secondary
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Population: The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 301.870 titers | Standard Deviation 4.3641 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 173.625 titers | Standard Deviation 2.7202 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 664.889 titers | Standard Deviation 2.973 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 1627.741 titers | Standard Deviation 2.6501 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 195.059 titers | Standard Deviation 3.068 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 133.655 titers | Standard Deviation 3.2545 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 171.645 titers | Standard Deviation 2.8681 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 1013.096 titers | Standard Deviation 2.8774 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 1845.542 titers | Standard Deviation 2.6503 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 147.911 titers | Standard Deviation 3.9771 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 216.617 titers | Standard Deviation 3.723 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 174.350 titers | Standard Deviation 3.5613 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 330.530 titers | Standard Deviation 2.8422 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 2375.689 titers | Standard Deviation 2.322 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 1700.053 titers | Standard Deviation 2.8334 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 792.188 titers | Standard Deviation 2.297 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 317.495 titers | Standard Deviation 4.2611 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 1111.904 titers | Standard Deviation 2.8305 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 421.869 titers | Standard Deviation 3.3192 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 1402.290 titers | Standard Deviation 2.3704 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 265.287 titers | Standard Deviation 3.6827 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 236.879 titers | Standard Deviation 3.7524 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 2721.933 titers | Standard Deviation 2.7489 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 284.084 titers | Standard Deviation 3.0997 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 1254.241 titers | Standard Deviation 2.932 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 175.809 titers | Standard Deviation 2.3936 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 191.152 titers | Standard Deviation 2.4129 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 210.045 titers | Standard Deviation 2.6297 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 126.603 titers | Standard Deviation 2.9179 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 3052.067 titers | Standard Deviation 2.1718 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 1591.849 titers | Standard Deviation 2.3855 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 360.492 titers | Standard Deviation 2.4772 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 3955.571 titers | Standard Deviation 3.3468 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 623.730 titers | Standard Deviation 2.8041 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 253.696 titers | Standard Deviation 3.8848 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 1617.127 titers | Standard Deviation 3.2917 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 807.498 titers | Standard Deviation 2.911 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 154.168 titers | Standard Deviation 5.4433 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 288.123 titers | Standard Deviation 6.6294 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 2008.570 titers | Standard Deviation 2.6719 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 75.715 titers | Standard Deviation 1.8549 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 408.985 titers | Standard Deviation 2.0742 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 134.706 titers | Standard Deviation 2.8976 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 1815.393 titers | Standard Deviation 2.2767 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 807.740 titers | Standard Deviation 2.2712 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 415.167 titers | Standard Deviation 2.322 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 1163.062 titers | Standard Deviation 2.3845 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 687.391 titers | Standard Deviation 3.4095 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 1837.995 titers | Standard Deviation 3.4748 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 310.262 titers | Standard Deviation 6.7709 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 6128.616 titers | Standard Deviation 2.8347 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 4793.501 titers | Standard Deviation 2.8151 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 1100.769 titers | Standard Deviation 2.771 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 1027.909 titers | Standard Deviation 4.3847 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 251.617 titers | Standard Deviation 6.1263 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 497.175 titers | Standard Deviation 4.5434 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 211 | 84.518 titers | Standard Deviation 2.8642 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 8 | 157.993 titers | Standard Deviation 4.5998 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 15 | 130.610 titers | Standard Deviation 4.3417 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 29 | 129.860 titers | Standard Deviation 3.9097 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 36 | 192.185 titers | Standard Deviation 3.8983 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 43 | 111.508 titers | Standard Deviation 3.9442 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 57 | 108.232 titers | Standard Deviation 3.728 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Day 120 | 99.688 titers | Standard Deviation 2.9239 |
Secondary
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Population: The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 51.515 titers | Standard Deviation 1.1962 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 92.943 titers | Standard Deviation 2.4539 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 215.648 titers | Standard Deviation 3.3361 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 122.337 titers | Standard Deviation 3.0011 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 61.466 titers | Standard Deviation 1.7283 |
| Dose Escalation CVnCoV: 2 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 510.141 titers | Standard Deviation 4.084 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 55.237 titers | Standard Deviation 1.4574 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 215.011 titers | Standard Deviation 3.5638 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 97.041 titers | Standard Deviation 2.5246 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 201.936 titers | Standard Deviation 4.2892 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 4 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 73.596 titers | Standard Deviation 2.2529 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 126.160 titers | Standard Deviation 3.6256 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 418.085 titers | Standard Deviation 3.9185 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 102.077 titers | Standard Deviation 4.232 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 53.447 titers | Standard Deviation 1.5 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 237.379 titers | Standard Deviation 3.7169 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 144.011 titers | Standard Deviation 3.1421 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 6 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 55.894 titers | Standard Deviation 1.6444 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 70.541 titers | Standard Deviation 1.9584 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 53.520 titers | Standard Deviation 1.3017 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 58.735 titers | Standard Deviation 1.549 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 255.615 titers | Standard Deviation 3.588 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 52.773 titers | Standard Deviation 1.2523 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 884.327 titers | Standard Deviation 3.598 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 532.756 titers | Standard Deviation 3.3394 |
| Dose Escalation CVnCoV: 8 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 161.237 titers | Standard Deviation 2.5113 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 351.489 titers | Standard Deviation 4.7386 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 222.516 titers | Standard Deviation 3.4086 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 60.458 titers | Standard Deviation 1.5674 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 208.484 titers | Standard Deviation 3.7448 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 1401.175 titers | Standard Deviation 3.7419 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 739.659 titers | Standard Deviation 3.9186 |
| Dose Escalation CVnCoV: 12 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 139.858 titers | Standard Deviation 4.1588 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 68.942 titers | Standard Deviation 3.043 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 74.346 titers | Standard Deviation 2.7022 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 69.659 titers | Standard Deviation 2.9999 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 231.544 titers | Standard Deviation 2.8738 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 948.298 titers | Standard Deviation 2.7761 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 1280.261 titers | Standard Deviation 2.656 |
| Dose Escalation CVnCoV: 16 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 321.393 titers | Standard Deviation 3.2174 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 89.597 titers | Standard Deviation 4.1779 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 74.942 titers | Standard Deviation 4.0629 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 388.660 titers | Standard Deviation 6.5376 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 2035.914 titers | Standard Deviation 3.3154 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 1516.255 titers | Standard Deviation 3.781 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 390.307 titers | Standard Deviation 4.9577 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 551.059 titers | Standard Deviation 3.749 |
| Dose Escalation CVnCoV: 20 µg | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 72.203 titers | Standard Deviation 3.5712 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 54.694 titers | Standard Deviation 1.4938 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 54.303 titers | Standard Deviation 1.4598 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 50.000 titers | Standard Deviation 1 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 52.644 titers | Standard Deviation 1.2734 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 54.509 titers | Standard Deviation 1.329 |
| Dose Escalation Placebo | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 50.000 titers | Standard Deviation 1 |
Secondary
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline.
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Population: Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 8 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 8 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 7 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 24 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 34 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 26 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 16 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 13 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 35 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 9 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 24 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 18 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 8 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 28 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 7 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 14 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 22 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 36 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 22 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 9 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 28 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 29 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 8 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 9 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 19 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 21 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 12 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 35 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 19 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 39 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 45 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 28 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 23 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 16 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 3 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 4 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 7 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 25 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 22 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 4 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 5 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 4 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 5 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 4 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 10 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 14 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 15 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 12 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 2 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 2 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 9 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 10 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 9 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 5 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 11 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 1 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 211 | 2 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 57 | 4 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 43 | 4 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 36 | 4 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 29 | 2 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 15 | 4 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 8 | 3 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies | Day 120 | 2 Participants |
Secondary
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline.
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Population: Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 26 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 23 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 23 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 29 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 38 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 42 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 42 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 18 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 42 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 39 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 22 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 27 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 44 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 17 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 44 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 31 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 43 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 38 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 39 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 19 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 23 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 31 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 27 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 22 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 27 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 19 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 44 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 34 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 29 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 28 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 39 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 43 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 27 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 14 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 9 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 24 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 26 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 16 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 26 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 24 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 11 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 15 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 8 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 16 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 16 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 15 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 16 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 16 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 7 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 6 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 11 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 12 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 12 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 11 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 12 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 10 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 57 | 7 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 43 | 12 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 36 | 17 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 29 | 9 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 15 | 8 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 8 | 12 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 211 | 8 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies | Day 120 | 10 Participants |
Secondary
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline.
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Population: Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 13 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 9 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 20 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 31 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 7 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 8 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 8 Participants |
| Dose Escalation CVnCoV: 2 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 23 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 32 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 8 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 11 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 8 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 13 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 37 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 30 Participants |
| Dose Escalation CVnCoV: 4 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 22 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 16 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 26 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 24 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 33 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 10 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 8 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 37 Participants |
| Dose Escalation CVnCoV: 6 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 9 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 34 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 17 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 10 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 12 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 13 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 43 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 40 Participants |
| Dose Escalation CVnCoV: 8 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 34 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 20 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 7 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 26 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 4 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 4 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 23 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 17 Participants |
| Dose Escalation CVnCoV: 12 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 21 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 16 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 6 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 8 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 16 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 13 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 14 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 5 Participants |
| Dose Escalation CVnCoV: 16 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 5 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 1 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 2 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 11 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 8 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 11 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 9 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 1 Participants |
| Dose Escalation CVnCoV: 20 µg | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 12 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 211 | 1 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 8 | 7 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 15 | 5 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 29 | 4 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 36 | 3 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 43 | 2 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 57 | 2 Participants |
| Dose Escalation Placebo | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Day 120 | 3 Participants |