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CV0501

Phase 1

COVID-19 | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Feb 21, 2025

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment185
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05477186Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years OldPHASE1 COMPLETED 185Aug 12, 2022Aug 18, 2023Feb 21, 202517 United States, Australia +1
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Study Endpoints
Primary Endpoints
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
From Day 1 to Day 7 (including Day 7)

Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.

Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
From Day 1 to Day 7 (including Day 7)

Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.

Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
From Day 1 to day 28 (including day 28)

An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.

Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
From Day 1 up to Day 180 (including Day 180)

An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.

Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
From Day 1 up to Day 180 (including Day 180)

An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.

Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
From Day 1 up to Day 180 (including Day 180)

An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
8 days from vaccination at Day 1

An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10\^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10\^6/uL; Male: 4.63-6.08x 10\^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10\^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10\^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10\^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10\^3/uL; Platelets: 163-375 x 10\^3/uL; Urea Nitrogen: 5-20 mg/dL.

Secondary Endpoints
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
At Day 1, Day 15, Day 29, Day 91, and Day 181
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
At Day 15, Day 29, Day 91, and Day 181
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
At day 29 (28 days after the booster dose)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part A: CV0501 Dose Cohort 1 (12 μg)EXPERIMENTALHealthy participants received a single dose of 12 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
Part A: CV0501 Dose Cohort 2 (25 μg)EXPERIMENTALHealthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
Part A: CV0501 Dose Cohort 3 (50 μg)EXPERIMENTALHealthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
Part A: CV0501 Dose Cohort 4 (100 μg)EXPERIMENTALHealthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
Part A: CV0501 Dose Cohort 5 (200 μg)EXPERIMENTALHealthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
Part B: CV0501 Dose Cohort 6 (3 μg)EXPERIMENTALHealthy participants received a single dose of 3 μg CV0501 vaccine intramuscularly at Day 1.
Part B: CV0501 Dose Cohort 7 (6 μg)EXPERIMENTALHealthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
Interventions
NameTypeDescription
CV0501 (3 μg)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0501 (6 μg)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0501 (12 μg)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0501 (25 μg)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0501 (50 μg)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0501 (100 μg)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0501 (200 μg)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites17

Inclusion Criteria: 1. Must provide documented informed consent prior to any study procedures being performed 2. Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits 3. Has received at least 2 doses of Comirnaty or Moderna COVID-19 ...

Countries:United StatesAustraliaPhilippines
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