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.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
280
Participants will receive an intramuscular injection by needle in the deltoid area.
Participants will receive an intramuscular injection by needle in the deltoid area.
Universitair Ziekenhuis Ghent
Ghent, Belgium
Ludwig-Maximilians-Universität München
München, Bavaria, Germany
Medical University Hannover (MHH)
Hanover, Germany
University Hospital Tübingen Institut für Tropenmedizin
Tübingen, Germany
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
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
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)
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: * 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)
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)
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
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
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
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
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
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
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
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
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