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HBVAXPRO

Phase 4

Hepatitis B | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Trials Updated: Jul 27, 2022

HBVAXPRO development status

Highest phase Phase 4 run by GlaxoSmithKline (NCT00603252)
Phase scored for MRKPhase 3
Registered trials 6 across 2 sponsors since Oct 2007

HBVAXPRO target and mechanism

ModalityMonoclonal antibody

Also known as 2XP HEPTAVAX™-II SC, RECOMBIVAX HB, 1XP HEPTAVAX™-II SC

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment207

FDA Designations

No designations recorded

HBVAXPRO clinical trials

HBVAXPRO · 1 trial · 1 indication

Phase 3 1
NCT04490499A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)Hepatitis B
COMPLETED207 Analytics
PHASE3COMPLETED
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™
Day 30

Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.

Secondary Endpoints

Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Day 1 and Day 30
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
HBVAXPRO™EXPERIMENTALHealthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).

Interventions

NameTypeDescription
HBVAXPRO™BIOLOGICALSingle 0.5 mL intramuscular dose
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Eligibility Criteria

Age Range8 Years to 10 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator. * Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxe...

Countries:Finland
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Frequently asked questions about HBVAXPRO

What is HBVAXPRO used for?

HBVAXPRO is used for protection against hepatitis B, an infectious disease of the liver. It is a vaccine candidate developed by Merck & Company, Inc. (ticker MRK) and is given to prevent hepatitis B infection. The program has been studied in a Phase 3 hepatitis B vaccine challenge trial.

Who makes HBVAXPRO?

HBVAXPRO is made by Merck & Company, Inc., which trades under the ticker MRK. Merck is the developer of the hepatitis B vaccine candidate. The company has sponsored the clinical trial evaluating HBVAXPRO in hepatitis B.

What phase is HBVAXPRO in?

HBVAXPRO is in Phase 3 development for hepatitis B. The program has one completed Phase 3 trial and no active trials. It is an investigational vaccine candidate and is not described as approved.

What clinical trials is HBVAXPRO in?

HBVAXPRO has been studied in one completed Phase 3 trial, NCT04490499, titled A Hepatitis B Vaccine Challenge Study After Previous Vaxelis Vaccination (V419-013). The trial enrolled 207 participants in Finland, included both sexes, and had a minimum age of 8 years. It was an uncontrolled study.

Is HBVAXPRO the same as HBVAXPRO™?

Yes, HBVAXPRO and HBVAXPRO™ refer to the same hepatitis B vaccine candidate from Merck & Company, Inc. The trademark symbol is simply a stylized version of the same name. Both names point to the same Phase 3 program for hepatitis B.