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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001286-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
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This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation CVnCoV | Experimental | Participants will be vaccinated with CVnCoV at escalating dose levels on Day 1 and Day 29. Safety data will inform the decision to continue enrolling at the current dose level, or to proceed to dose escalation. Initially, dose levels of 2, 4 and 8 μg will be evaluated. Dose levels of 2, 4, 6, 8 and 12µg will be evaluated with potential increase to dose levels up to 20 μg. |
|
| Dose Escalation Placebo | Placebo Comparator | Participants will be given placebo on Day 1 and Day 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVnCoV Vaccine | Biological | Participants will receive an intramuscular injection by needle in the deltoid area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to 24 hours after vaccination on Day 1 |
| 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:
| Up to 60 hours after vaccination on Day 1 |
| 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. | Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
The following criterion applies to all open-label sentinel participants:
The following criteria apply to all participants, except those with SARS-CoV-2 positive serology:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Ghent | Ghent | 9000 | Belgium | |||
| Ludwig-Maximilians-Universität München |
Of the 408 participants who were screened, 280 participants were enrolled.
This trial was performed in Belgium and Germany between June 2020 and December 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Dose Escalation CVnCoV: 4 µg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants 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:
| Only participants with available data were used for this analysis. | Posted | Count of Participants | Participants | Up to 24 hours after vaccination on Day 1 |
|
Day 1 up to Day 393
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information | CureVac AG | +49 6976805870 | clinicaltrials@curevac.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2020 | Apr 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2021 | Apr 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
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| ID | Term |
|---|---|
| C000722934 | CVnCoV COVID-19 vaccine |
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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.
| Placebo | Drug | Participants will receive an intramuscular injection by needle in the deltoid area. |
|
| Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
| 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. | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
| 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. | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
| 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. | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
| 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. | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
| 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. | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
| 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. | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
| 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:
| Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
| 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. | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
| Number of Participants With One or More Serious Adverse Events (SAEs) | An SAE was defined as any untoward medical occurrence that, at any dose:
| Baseline to Day 393 |
| 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:
| Baseline to Day 393 |
| 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. | Day 1 to Day 393 |
| Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
| Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
| 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. | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
| Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
| 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. | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
| Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Measured using an activity assay. | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
| München |
| Bavaria |
| 80802 |
| Germany |
| Medical University Hannover (MHH) | Hanover | 30625 | Germany |
| University Hospital Tübingen Institut für Tropenmedizin | Tübingen | 72074 | Germany |
| Withdrawal by Subject |
|
| Other |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline Immunestatus | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
| 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:
| Only participants with available data were used for this analysis. | Posted | Count of Participants | Participants | Up to 60 hours after vaccination on Day 1 |
|
|
|
| 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. | Only participants with available data were used for this analysis. | Posted | Count of Participants | Participants | Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
|
|
|
| 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. | Only participants who experienced solicited local AEs were used for this analysis. | Posted | Mean | Standard Deviation | days | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
|
|
|
| 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. | Only participants with available data were used for this analysis. | Posted | Count of Participants | Participants | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
|
|
|
| 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. | Only participants who experienced solicited systemic AEs were used for this analysis. | Posted | Mean | Standard Deviation | days | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) |
|
|
|
| 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. | Only participants with available data were used for this analysis. | Posted | Count of Participants | Participants | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
|
|
|
| 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:
| 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. | Posted | Count of Participants | Participants | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
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| 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:
| Only participants with available data were used in this analysis. | Posted | Count of Participants | Participants | Baseline to Day 393 |
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| 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:
| 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. | Posted | Count of Participants | Participants | Baseline to Day 393 |
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| 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. | Only participants with available data were used for this analysis. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
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| 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. | 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). | Posted | Count of Participants | Participants | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
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| Secondary | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). | 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. | Posted | Geometric Mean | Standard Deviation | titers | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
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| 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. | 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). | Posted | Count of Participants | Participants | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
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| Secondary | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies | Measured using Enzyme-Linked Immunosorbent Assay (ELISA). | 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. | Posted | Geometric Mean | Standard Deviation | titers | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
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| 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. | 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). | Posted | Count of Participants | Participants | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
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| Secondary | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies | Measured using an activity assay. | 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. | Posted | Geometric Mean | Standard Deviation | titers | Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211 |
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| 0 |
| 47 |
| 2 |
| 47 |
| 23 |
| 47 |
| EG001 | 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. | 0 | 48 | 0 | 48 | 28 | 48 |
| EG002 | 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. | 0 | 48 | 1 | 48 | 26 | 48 |
| EG003 | 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. | 0 | 49 | 1 | 49 | 25 | 49 |
| EG004 | 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. | 0 | 28 | 2 | 28 | 22 | 28 |
| EG005 | 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. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG006 | 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. | 0 | 12 | 0 | 12 | 12 | 12 |
| EG007 | 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. | 0 | 32 | 1 | 32 | 17 | 32 |
| Crohn's disease | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Peroneal nerve palsy | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Retinal disorder | Eye disorders | MedDRA (24.1) | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Oral Herpes | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Enterobiasis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Epstein-Barr virus infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Morton's neuralgia | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Eccymosis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Macrocytosis | Blood and lymphatic system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Cardiovascular disorder | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Asthenopia | Eye disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Dysmerorrhoea | Reproductive system and breast disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA (24.1) | Non-systematic Assessment |
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Not provided
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine |
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| Grade 2 |
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| Grade 3 |
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| Grade 2 |
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| Grade 3 |
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| Moderate |
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| Severe |
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| Day 15 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 57 |
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| Day 120 |
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| Day 211 |
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| Day 15 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 57 |
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| Day 120 |
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| Day 211 |
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| Day 15 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 57 |
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| Day 120 |
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| Day 211 |
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| Day 15 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 57 |
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| Day 120 |
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| Day 211 |
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| Day 15 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 57 |
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| Day 120 |
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| Day 211 |
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| Day 15 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 57 |
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| Day 120 |
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| Day 211 |
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