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VLA2001

Phase 3

SARS-CoV-2 Virus Infection | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Sep 1, 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-BlindCONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment4,493
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04956224Safety and Immunogenicity of VLA2001 Adults Aged ≥56 YearsPHASE3 COMPLETED 306 — — Aug 9, 2021Nov 18, 2022Sep 1, 20238 New Zealand
NCT04864561COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222PHASE3 COMPLETED 4,034 — — Apr 26, 2021Mar 13, 2023Mar 20, 202331 United Kingdom
NCT04671017Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy SubjectsPHASE1 COMPLETED 153 — — Dec 16, 2020Apr 6, 2022Apr 22, 20224 United Kingdom
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Study Endpoints
Primary Endpoints
Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination
Day 43
Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies
Day 43
Immune response as determined by the seroconversion rate (SCR) of SARS-CoV-2-specific neutralizing antibodies
Day 43
Immune response measured after completion of a 2-dose immunization schedule, as determined by the geometric mean titer (GMT) ratio in adults and GMT in adolescents of SARS-CoV-2-specific neutralizing antibodies
Day 43
Immune response measured after completion of a 2-dose immunization schedule, as determined by Seroconversion in adults and adolescents (definded as 4-fold increase from baseline) of SARS-CoV-2-specific neutralizing antibodies
Day 43
Frequency and severity of any Adverse Events (AE)
Up to Day 43 post-vaccination
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
within 7 days after any vaccination
Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay
Day 36
Secondary Endpoints
Frequency and severity of solicited injection site and systemic reactions after each vaccination
within 7 days
Frequency and severity of any unsolicited Adverse Event (AE)
until Day 43
Frequency and severity of any unsolicited vaccine-related Adverse Event (AE)
until Day 43
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VLA2001EXPERIMENTAL -
AZD1222ACTIVE_COMPARATOR\<30 years will receive VLA2001; participants aged ≥30 years will be randomised 2:1 to receive VLA2001 or AZD1222
VLA2001 - adolescent partEXPERIMENTAL≥12 to \< 18 years will be randomized 1:1 to receive VLA2001 or Placebo
PlaceboPLACEBO_COMPARATOR≥12 to \< 18 years will be randomized 1:1 to receive VLA2001 or Placebo
Low Dose: VLA2001EXPERIMENTAL -
Medium Dose: VLA2001EXPERIMENTAL -
High Dose: VLA2001EXPERIMENTAL -
Booster: High Dose: VLA2001EXPERIMENTAL -
Interventions
NameTypeDescription
VLA2001BIOLOGICALwhole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide (Wuhan strain) 2 vaccinations 28 days apart Booster Vaccination on Visit B1
AZD1222BIOLOGICAL2 vaccinations 28 days apart AZD1222 is a recombinant, replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 S surface glycoprotein.
VLA2001 - adolescent partBIOLOGICALwhole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxid 2 vaccinations 28 days apart and with a booster vaccination on day 208. Placebo group will receive VLA2001 on day 208 and following second vaccination 28 days later.
PlaceboBIOLOGICAL2 vaccinations 28 days apart with placebo (PBS buffer based on Dulbecco's PBS media formulation without Calcium and Magnesium )
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Eligibility Criteria
Age Range56 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: 1. All participants must have read, understood, and signed the informed consent form (ICF). 2. Participants of either gender aged 56 years or older at screening. 3. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period...

Countries:New ZealandUnited Kingdom
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