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CVnCoV Vaccine

Phase 3

Coronavirus | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Oct 6, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment2,357
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04674189A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19PHASE3 COMPLETED 2,357Dec 23, 2020Jun 8, 2022Oct 6, 20231 Germany
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced a Medically Attended Adverse Event (AE) Occurring in the Following 6 Months After Dose 2
Up to 6 months after Dose 2 (Days 29 to 211)

Medically attended AEs were defined as AEs with medically attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.

Number of Participants Who Experienced a Serious Adverse Event (SAE)
Day 1 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 occurrence of each AE.

Intensity of SAEs Per the Investigator's Assessment
Day 1 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 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 Who Experienced an Adverse Event of Special Interest (AESI) Occurring in the Following 1 Year After Dose 2
Up to 1 year after Dose 2 (Days 29 to 393)

The following events were considered and collected as AESI throughout the trial: * AEs with a suspected immune-mediated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. * COVID-19. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.

Number of Participants Who Experienced Death Due to SAE
Day 1 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 Who Experienced an AE Leading to Vaccine Withdrawal Occurring in the Following 1 Year After Dose 2
Up to 1 year after Dose 2 (Days 29 to 393)
Number of Participants Who Experienced an AE Leading to Trial Discontinuation Occurring in the Following 1 Year After Dose 2
Up to 1 year after Dose 2 (Days 29 to 393)
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Day 1 to 28 days after Dose 2 (Day 57)

eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.

Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Day 1 to 28 days after Dose 2 (Day 57)

eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. 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.

Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG) on Day 29 and Day 43
Baseline (Day 1), Day 29 and Day 43

Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme-linked immunosorbent assay (ELISA). Percentage with 95% confidence interval (CI) of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 Spike Protein RBD IgG antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43
Day 1, Day 29 and Day 43

Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA and expressed as geometric mean of titers (GMT) with 95% CI, by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Secondary Endpoints
Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
Baseline (Day 1), Day 29 and Day 43
SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43
Day 1, Day 29 and Day 43
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
CVnCoV: Group 1, Lot 1EXPERIMENTALParticipants in Group 1 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
CVnCoV: Group 2, Lot 2EXPERIMENTALParticipants in Group 2 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
PlaceboPLACEBO_COMPARATORParticipants will receive a placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Interventions
NameTypeDescription
CVnCoV VaccineBIOLOGICALIntramuscular injection
PlaceboDRUGIntramuscular injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female participants 18 years of age or older. * Health care workers (HCWs), employees or students in clinical training. * Provide written informed consent prior to initiation of any trial procedures. * Expected compliance with protocol procedures and availability for c...

Countries:Germany
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