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CV0701 mRNA COVID-19 Vaccine

Phase 2

SARS-CoV-2 | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 23, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment692
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05960097A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy AdultsPHASE2 COMPLETED 692Aug 1, 2023Aug 30, 2024Oct 23, 202517 United States, Australia
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Study Endpoints
Primary Endpoints
Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
At Day 29
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
At Day 29
Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
At Day 29
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Day 1 to Day 7

Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.

Part A: Number of Participants Reporting Any Solicited Systemic AEs
Day 1 to Day 7

Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (\>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.

Part A: Number of Participants Reporting Any Unsolicited AEs
Day 1 to Day 28

An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.

Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Day 1 to Day 181

An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement. An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations. AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. "Any" indicates the occurrence of the event regardless of its intensity grade.

Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Day 1 to Day 7

Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.

Part B: Number of Participants Reporting Any Solicited Systemic AEs
Day 1 to Day 7

Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature \>= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.

Part B: Number of Participants Reporting Any Unsolicited AEs
Day 1 to Day 28

An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.

Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
Day 1 to Day 181
Secondary Endpoints
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
At Day 91 and Day 181
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
At Day 91 and Day 181
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
At Day 29, Day 91 and Day 181
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part A: CV0701 mRNA COVID-19 Vaccine (Low dose)EXPERIMENTALParticipants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
Part A: CV0701 mRNA COVID-19 Vaccine (Medium dose)EXPERIMENTALParticipants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
Part A: CV0701 mRNA COVID-19 Vaccine (High dose)EXPERIMENTALParticipants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
Part A: CV0601 mRNA COVID-19 vaccineEXPERIMENTALParticipants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
Part A: Control VaccineACTIVE_COMPARATORParticipants received one dose of the control vaccine at Day 1.
Part B: CV0801 mRNA COVID-19 vaccine (Maximum storage condition)EXPERIMENTALParticipants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
Part B: CV0801 mRNA COVID-19 vaccine (Intermediate storage condition)EXPERIMENTALParticipants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
Part B: CV0801 mRNA COVID-19 vaccine (Baseline-control storage condition)EXPERIMENTALParticipants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
Interventions
NameTypeDescription
CV0701 mRNA COVID-19 Vaccine (Low dose)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0701 mRNA COVID-19 Vaccine (Medium dose)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0701 mRNA COVID-19 Vaccine (High dose)BIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0601 mRNA COVID-19 VaccineBIOLOGICALStudy vaccine was administered as a single intramuscular injection.
Control vaccineBIOLOGICALStudy vaccine was administered as a single intramuscular injection.
CV0801 mRNA COVID-19 VaccineBIOLOGICALStudy vaccine was administered as a single intramuscular injection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites17

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is at least 18 years old and has achieved legal age according to local regulations in each participating country. 2. Must provide documented informed consent prior to any study procedures being per...

Countries:United StatesAustralia
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