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CVnCoV

Phase 2

Covid19 | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Apr 29, 2024

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 Enrollment39,680
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04652102A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and OlderPHASE2 COMPLETED 39,680Dec 11, 2020Jun 10, 2022Apr 29, 202446 Argentina, Belgium +8
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity
Day 44 to Day 393

A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). * Primary efficacy cases were confirmed by an Adjudication Committee. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE)
Day 1 to Day 211

Medically-attended AEs were defined as AEs with medically-attended visits that were 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. Clinic visits for COVID-19 testing resulting in negative test results were not considered as medically attended visits, if there is no confirmed diagnosis and no prescribed concomitant medication. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Number of Participants Who Experienced One or More Serious AE (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 SAE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Intensity of SAEs as Per Investigator 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 of each SAE reported during the trial. Each SAE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI)
Day 1 to Day 393

AESIs included: * AEs with a suspected immune-medicated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. The Investigator assessed the relationship between trial vaccine and occurrence of each AESI. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Number of Participants Who Experienced a Fatal SAE
Day 1 to Day 393

A fatal SAE was defined as an SAE that resulted in death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE
Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment
Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. The Investigator made an assessment of intensity of each solicited AE reported during the trial. Each solicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Phase 2b Participants Only: Duration of Solicited AEs
Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 are included. In each case only the longest consecutive duration is displayed. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE
Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)

eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment
Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)

eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity of each unsolicited AE reported during the trial. Each unsolicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation
Day 1 to Day 393

Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.

Secondary Endpoints
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19
Day 44 to Day 393
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19
Day 44 to Day 393
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With "Wild Type" and "Alpha" SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants
Day 44 to Day 393
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Randomized Observer-blinded Phase 2b: CVnCoV vaccineEXPERIMENTALParticipants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Randomized Observer-blinded Phase 2b: PlaceboPLACEBO_COMPARATORParticipants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Randomized Observer-blinded Phase 3: CVnCoV vaccineEXPERIMENTALParticipants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Randomized Observer-blinded Phase 3: PlaceboPLACEBO_COMPARATORParticipants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Open-label PhaseEXPERIMENTALAfter unblinding, the trial will shift from a randomized observer-blinded to an open-label design, and the following cohorts will be defined: Cohort A: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to receive an authorized/licensed vaccine for preventing COVID-19 (AV) as standard of care through their national vaccination program. Cohort B: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to remain in the trial without receiving any AV. Participants on the placebo arm will be withdrawn.
Interventions
NameTypeDescription
CVnCoVBIOLOGICALIntramuscular (IM) injection.
PlaceboBIOLOGICALIntramuscular (IM) injection.
Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination programBIOLOGICALIntramuscular (IM) injection will be received as standard of care (SoC) outside the study.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites46

Inclusion Criteria: * Male or female participants 18 years of age or older. * Be willing and able to provide written informed consent prior to initiation of any trial procedures. * Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. *...

Countries:ArgentinaBelgiumColombiaDominican RepublicGermanyMexicoNetherlandsPanamaPeruSpain
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