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HBV-MPL vaccine 208129

Phase 4

Hepatitis B | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 30, 2017

HBV-MPL vaccine 208129 development status

Highest phase Phase 4 (NCT00524576)
Phase scored for GSKPhase 3
Registered trials 28 across 1 sponsor since Sep 2005

HBV-MPL vaccine 208129 target and mechanism

ModalityVaccine

Also known as HBV-MPL 208129, Engerix™-B

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials7
Total Enrollment3,092

FDA Designations

No designations recorded

HBV-MPL vaccine 208129 clinical trials

HBV-MPL vaccine 208129 · 7 trials · 1 indication

Phase 3 6Phase 1 1
NCT00697866Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as ControlHepatitis B
COMPLETED951 Analytics
NCT00697554Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of AgeHepatitis B
COMPLETED93 Analytics
NCT00698061Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15yHepatitis B
COMPLETED145 Analytics
NCT00696917Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15yHepatitis B
COMPLETED1,303 Analytics
NCT00697749Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 GenotypeHepatitis B
COMPLETED230 Analytics
NCT00697216Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).Hepatitis B
COMPLETED340 Analytics
PHASE3COMPLETED
Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
Hepatitis B
NCT00697866951
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PHASE3COMPLETED
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
Hepatitis B
NCT0069755493
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PHASE3COMPLETED
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y
Hepatitis B
NCT00698061145
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PHASE3COMPLETED
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
Hepatitis B
NCT006969171,303
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PHASE3COMPLETED
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
Hepatitis B
NCT00697749230
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PHASE3COMPLETED
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
Hepatitis B
NCT00697216340
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Study Endpoints

Primary Endpoints

Anti-HBs antibody concentrations
At month 3
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Full course of vaccination
Incidence of serious adverse events
Study period
Occurrence and intensity of solicited local and general symptoms
4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
During the course of the study
Occurrence of serious adverse events
During the course of the study

Secondary Endpoints

Anti-HBs antibody concentrations
At M1, M2, M3
Anti-RF1 antibody titres in a subset of 50 subjects per group
At months 0 and 3
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
During a 4-day follow-up after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALHBV-MPL Lot A
Group BEXPERIMENTALHBV-MPL Lot B
Group CEXPERIMENTALHBV-MPL Lot C
Group DACTIVE_COMPARATOREngerix™-B
Group A1ACTIVE_COMPARATORNon-responders to vaccination after at least 7 previous injections
Group A2EXPERIMENTALNon-responders to vaccination after at least 7 previous injections
Group B1ACTIVE_COMPARATORVaccine-responders requiring a booster dose
Group B2EXPERIMENTALVaccine-responders requiring a booster dose
Group C1ACTIVE_COMPARATORVolunteers participating in the hospital's vaccination program
Group C2EXPERIMENTALVolunteers participating in the hospital's vaccination program
Group D1ACTIVE_COMPARATORUnvaccinated haemodialysis patients
Group D2EXPERIMENTALUnvaccinated haemodialysis patients

Interventions

NameTypeDescription
HBV-MPL vaccine 208129BIOLOGICAL3 consecutive lots; 3-dose intramuscular injection
Engerix™-BBIOLOGICAL3-dose intramuscular injection
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Eligibility Criteria

Age Range15 Years to 50 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * A male or female between, and including, 15 and 50 years of age at the time of the first vaccination. * Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable * Free of obvious health problems as established by medical...

Countries:AustraliaCzechiaGermanyItalyNetherlandsSwitzerlandUnited KingdomBelgiumDenmark
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Competitive Landscape -Hepatitis B 40 trials

Top 6 of 8 competitors

CompanyTickerTrialsLead PhaseDrugs
Gilead Sciences, Inc.GILD3PHASE3Viread, Tenofovir alafenamide
Vir Biotechnology, Inc.VIR6PHASE3Tobevibart, Elebsiran
Bausch Health Companies Inc.BHC1PHASE3Larsucosterol
GSK plc Sponsored ADRGSK4PHASE2Daplusiran/Tomligisiran, Bepirovirsen
Aligos Therapeutics, Inc.ALGS1PHASE2ALG-000184
Precision BioSciences, Inc.DTIL2PHASE1PBGENE-HBV
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Frequently asked questions about HBV-MPL vaccine 208129

What is HBV-MPL vaccine 208129 used for?

HBV-MPL vaccine 208129 is an investigational vaccine being developed for the prevention of hepatitis B. It is designed to be evaluated in a range of populations, including healthy volunteers, non-responders to previous hepatitis B vaccination, and haemodialysis patients, all of whom are at risk of hepatitis B infection.

Who is developing HBV-MPL vaccine 208129?

HBV-MPL vaccine 208129 is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical trial program for this vaccine candidate.

What phase is HBV-MPL vaccine 208129 in?

HBV-MPL vaccine 208129 is in Phase 3 clinical development. The program includes multiple completed Phase 3 trials, such as NCT00698061, NCT00697866, and NCT00697749, as well as a completed Phase 1 trial, NCT00699231. It is an investigational vaccine and has not been approved by the FDA.

What clinical trials is HBV-MPL vaccine 208129 in?

HBV-MPL vaccine 208129 has been studied in seven completed clinical trials, including NCT00699231, a Phase 1 trial in haemodialysis patients; NCT00698061, a Phase 3 trial in non-responders; NCT00697866, a Phase 3 consistency trial; and NCT00697749, a Phase 3 trial in HLA-DQ2 positive healthy volunteers. All trials are completed.

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

Yes, HBV-MPL vaccine 208129 is also known as HBV-MPL 208129. The two names refer to the same investigational hepatitis B vaccine candidate developed by GSK plc.

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