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VLA2001

Phase 3

SARS-CoV-2 Virus Infection | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Sep 1, 2023

Development status

Highest phase Phase 3
Registered trials 5 across 1 sponsor since Dec 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials3
Total Enrollment4,493

FDA Designations

No designations recorded

Clinical trial landscape

VLA2001 · 4 trials · 2 indications

Phase 3 2Phase 2 1Phase 1 1
NCT04956224Safety and Immunogenicity of VLA2001 Adults Aged ≥56 YearsSARS-CoV-2 Virus Infection
COMPLETED306 Analytics
NCT04864561COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222SARS-CoV-2 Virus Infection
COMPLETED4,034 Analytics
PHASE3COMPLETED
Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years
SARS-CoV-2 Virus InfectionUnlock trial analytics
PHASE3COMPLETED
COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222
SARS-CoV-2 Virus InfectionUnlock trial analytics

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
GMT (Geometric Mean Titer) fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001
Day 15
Frequency and severity of solicited AEs (Adverse Events) (local and systemic reactions) after the VLA2001 booster vaccination
until Day 7
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 to 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 KingdomNetherlands
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Frequently asked questions about VLA2001

What is VLA2001 used for?

VLA2001 is an investigational vaccine candidate for SARS-CoV-2 infection, the virus that causes COVID-19. It is being developed to prevent SARS-CoV-2 virus infection in healthy individuals. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

Who makes VLA2001?

VLA2001 is being developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker symbol VALN. Valneva is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine candidate against SARS-CoV-2.

What phase is VLA2001 in?

VLA2001 is in Phase 2 clinical development. It has completed Phase 1 and Phase 3 trials, but the most recent trial listed is a Phase 2 study evaluating the vaccine as a booster. The vaccine remains investigational and is not yet approved for use.

What clinical trials is VLA2001 in?

VLA2001 has been studied in several completed clinical trials, including NCT04671017, a Phase 1 dose-finding study in the United Kingdom; NCT04864561, a Phase 3 trial comparing VLA2001 to AZD1222; NCT04956224, a Phase 3 study in adults aged 56 and older; and NCT05364242, a Phase 2 booster study.

How does VLA2001 work?

VLA2001 is an inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate. It contains whole virus particles that have been inactivated so they cannot cause disease, but can stimulate the immune system to produce a protective response against the virus. The vaccine is designed to induce immunity against SARS-CoV-2.

Is VLA2001 the same as a COVID-19 vaccine?

VLA2001 is a COVID-19 vaccine candidate specifically designed to prevent SARS-CoV-2 virus infection. It is an inactivated whole-virus vaccine, which is a different approach compared to mRNA vaccines. However, it is not yet approved and remains in clinical development.