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Rabipur

Phase 1

Rabies | Monoclonal antibody | Other |BioNTech SE|Last Updated: Dec 19, 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
ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03713086A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy AdultsPHASE1 COMPLETED 53Oct 12, 2018Nov 23, 2021Dec 19, 20242 Belgium, Germany
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1)
From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in a diary by the participant.

Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1)
From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. The intensity of local solicited AEs was graded as:Pain at injection site(Grade 0:absent,Grade 1:Does not interfere with activity, Grade 2:Interferes with activity/repeated use of non-narcotic pain reliever greater than \[\>\] 24 hours,Grade 3:prevent daily activity/repeated use of narcotic pain reliever); Redness(Grade 0:less than or equal to \[\<=\]2.5 centimeters(cm), Grade 1:2.5 to 5cm,Grade 2: 5.1 to 10cm, Grade 3: \>10cm);Swelling(Grade 0: \<=2.5 cm,Grade 1: 2.5 to 5cm and does not interfere with activity,Grade 2:5.1 to 10cm/interferes with activity,Grade 3:\>10cm or prevents daily activity);Itching(Grade 0:absent,Grade 1:Mild,no interference with normal activity,Grade 2:Moderate,some interference with normal activity,Grade 3:Significant, prevents normal activity).

Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1)
From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia on the day of vaccination and following 7 days after dose 1. All AEs were documented in diary by the participant.

Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1)
From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

The intensity of Systemic AEs was graded as: Fever(Grade 0: \<38 degree Celsius (°C), Grade 1: \>=38°C to 38.4°C, Grade 2:\>=38.5°C to 38.9°C, Grade 3: \>=39°C); Headache(Grade 0: absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Fatigue(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Chills(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Myalgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Arthralgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Nausea/Vomiting(Grade 0: Absent, Grade 1: Mild, no interference with activity/1-2 episodes/24 hours, Grade 2: Moderate, some interference with activity/\>2 episodes/ 24 hours, Grade 3: Severe, prevents daily activity, requires outpatient intravenous \[IV\] hydration); Diarrhea(Grade 0: Absent, Grade 1: 2-3 stools, Grade 2: 4-5 stools, Grade 3: 6 or more watery stools or requires outpatient IV hydration).

Number of Days of Local Solicited AEs Post Dose 1 (Day 1)
From Day 1 (post-dose 1) to Day 8

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.

Number of Days of Local Solicited AEs Post Dose 2
CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.

Number of Days of Local Solicited AEs Post Dose 3
Day 29 (post-dose 3) to Day 36

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.

Number of Days of Systemic Solicited AEs Post Dose 1
From Day 1 (post-dose 1) to Day 8

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, chills, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.

Number of Days of Systemic Solicited AEs Post Dose 2
CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, chills, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.

Number of Days of Systemic Solicited AEs Post Dose 3
Day 29 (post-dose 3) to Day 36

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.

Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs
From the first dose of vaccination up to 28 days after vaccination (up to Day 29)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The number of participants with unsolicited and related unsolicited AEs were reported.

Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs
From the first dose of vaccination up to 28 days after vaccination (up to Day 29)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The intensity of AEs was graded as: 1) Mild (Grade 1): An event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.; 2) Moderate (Grade 2): An event that caused sufficient discomfort to interfere with normal everyday activities.; 3) Severe (Grade 3): An event that prevented normal everyday activities. Number of participants with Grade 1, 2 and 3 unsolicited and related unsolicited AEs were reported.

Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months
From the first dose of vaccination up to 12 months

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.

Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months
From the first dose of vaccination up to 12 months

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any MAAEs were reported.

Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month
From the first dose of vaccination up to 12 months

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event.

Secondary Endpoints
Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months
From 12 months up to 24 months
Number of Participants With Related MAAEs From 12 Months up to 24 Months
From 12 months up to 24 months
Number of Participants With Any Related AESIs From 12 Months up to 24 Months
From 12 months up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Rabipur®ACTIVE_COMPARATORParticipants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
CV7202 1 mcgEXPERIMENTALParticipants received messenger ribonucleic acid (mRNA) CV7202 1 microgram (mcg) intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 1 mcg at Day 29.
CV7202 2 mcgEXPERIMENTALParticipants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29.
CV7202 5 mcgEXPERIMENTALParticipants received mRNA CV7202 5 mcg intramuscular injection at Day 1.
Interventions
NameTypeDescription
Rabipur®BIOLOGICAL3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm
Rabies mRNA vaccine CV7202BIOLOGICALCV7202 administered IM at Days 1 and 29 in the deltoid region of the arm
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion criteria: Subjects must satisfy the following criteria at trial entry: 1. Healthy male and female subjects aged 18 to 40 years inclusive. Healthy Subject is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent med...

Countries:BelgiumGermany
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