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HBV-MPL vaccine

Phase 3

Hepatitis B | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jun 17, 2008

HBV-MPL vaccine development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Jun 2008

HBV-MPL vaccine target and mechanism

ModalityVaccine

Also known as HBV-MPL vaccine (208129)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment703

FDA Designations

No designations recorded

HBV-MPL vaccine clinical trials

HBV-MPL vaccine · 3 trials · 1 indication

Phase 3 1Phase 2 2
NCT00696891Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in AdultsHepatitis B
COMPLETED380 Analytics
PHASE3COMPLETED
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HBs antibody concentrations
At Month 7

Secondary Endpoints

Anti-HBs antibody concentrations
At Months 1, 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of solicited general symptoms
4-day follow-up after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -
Group FACTIVE_COMPARATOR -

Interventions

NameTypeDescription
HBV-MPL vaccineBIOLOGICAL3-dose intramuscular injection
Engerix™-BBIOLOGICAL3-dose intramuscular injection
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Eligibility Criteria

Age Range50 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Age: 50 to 70 years old. * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * Written info...

Countries:BelgiumCanadaSwedenAustria
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Frequently asked questions about HBV-MPL vaccine

What is the HBV-MPL vaccine used for?

The HBV-MPL vaccine is an investigational vaccine being developed for the prevention of Hepatitis B. It is designed to be given to adults, including older adults aged 50 years and above, and has been studied in healthy volunteers across several countries. It remains in clinical development and is not an approved product.

Who is developing the HBV-MPL vaccine?

The HBV-MPL vaccine is being developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical program evaluating different formulations of the vaccine against its licensed Hepatitis B vaccine Engerix-B as the active comparator.

What phase is the HBV-MPL vaccine in?

The HBV-MPL vaccine has reached Phase 3 clinical development. Three trials have been completed, including one Phase 3 study and two Phase 2 studies, with a combined enrollment of 703 participants. The vaccine is investigational and has not been approved for use.

What clinical trials has the HBV-MPL vaccine been studied in?

The HBV-MPL vaccine has been evaluated in three completed trials: NCT00698906, a Phase 2 study in Austria with 160 adults aged 19 to 40; NCT00698555, a Phase 2 study in Belgium with 163 adults aged 18 to 40; and NCT00696891, a Phase 3 study in Belgium, Canada and Sweden with 380 adults aged 50 and older.

Is the HBV-MPL vaccine the same as HBV-MPL vaccine (208129)?

Yes, HBV-MPL vaccine (208129) is another name used for the HBV-MPL vaccine. Both names refer to the same GSK investigational Hepatitis B vaccine candidate, so searches using either term point to the same development program.

How was the HBV-MPL vaccine studied in its clinical trials?

The trials were randomized and active controlled, comparing different formulations of the HBV-MPL vaccine against Engerix-B, GSK's licensed Hepatitis B vaccine. The studies enrolled healthy adult volunteers and assessed immunogenicity, reactogenicity and safety. All three trials have been completed.