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VLA1701

Phase 2

Enterotoxigenic Escherichia Coli Infection | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Apr 23, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

VLA1701 · 1 trial · 2 indications

Phase 2 1
NCT03576183Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701Enterotoxigenic Escherichia Coli Infection
COMPLETED34 Analytics
PHASE2COMPLETED
Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701
Enterotoxigenic Escherichia Coli InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Subjects With Moderate to Severe Diarrhea
5 days after challenge

within 120 hours of challenge with ETEC strain LSN03-016011/A.

Secondary Endpoints

Disease Severity Score After Challenge With ETEC Strain LSN03-016011/ A
7 days after challenge
Percentage of Subjects With Solicited Adverse Events
7days after each vaccination
Percentage of Subjects With Any Adverse Events (AE)
until Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VLA1701ACTIVE_COMPARATORVLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli) The vaccine is administered orally in 2 doses about 1 week apart.
PlaceboPLACEBO_COMPARATORThe buffer component of VLA1701 will be used as Placebo. The vaccine is administered orally in 2 doses about 1 week apart.

Interventions

NameTypeDescription
VLA1701BIOLOGICALVLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
PlaceboBIOLOGICALbuffer component of VLA1701
Challenge StrainOTHERLSN03-016011/A
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and non-pregnant female subjects aged 18 to \<50 years; 2. BMI of 19.0 to 35.0 kg/m2 3. Willingness to participate after informed consent has been obtained from the subject prior to any study related procedures. 4. Completion of a training session and demonstrati...

Countries:United States
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Frequently asked questions about VLA1701

What is VLA1701 used for?

VLA1701 is an investigational monoclonal antibody being developed for the prevention or treatment of enterotoxigenic Escherichia coli (ETEC) infection, a cause of diarrhea. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does VLA1701 target?

VLA1701 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being studied for its ability to address enterotoxigenic Escherichia coli infection, which causes diarrhea.

Who makes VLA1701?

VLA1701 is being developed by Valneva SE, a biopharmaceutical company. Valneva's stock is traded under the ticker symbol VALN.

What phase is VLA1701 in?

VLA1701 is in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet approved by the FDA or other regulatory agencies, meaning it remains an investigational drug.

What clinical trials is VLA1701 in?

VLA1701 has been studied in one completed Phase 2 clinical trial, identified as NCT03576183. This trial, titled 'Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701,' enrolled 34 healthy volunteers in the United States and evaluated the drug's safety in the context of an ETEC challenge model.

Is VLA1701 the same as any other drug?

No alternative names for VLA1701 have been disclosed in available information. It is identified solely by its development code, VLA1701, and is not known to be marketed under any other name.