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HBV-MPL vaccine 208129

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 30, 2017

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

Clinical trial landscape

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 BUnlock trial analytics
PHASE3COMPLETED
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
Hepatitis BUnlock trial analytics
PHASE3COMPLETED
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y
Hepatitis BUnlock trial analytics
PHASE3COMPLETED
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
Hepatitis BUnlock trial analytics
PHASE3COMPLETED
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
Hepatitis BUnlock trial analytics
PHASE3COMPLETED
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
Hepatitis BUnlock trial analytics

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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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 currently in Phase 3 clinical development and has been studied in several patient populations, including pre-liver transplant patients, healthy volunteers, non-responders to existing vaccines, and haemodialysis patients.

Who makes HBV-MPL vaccine 208129?

HBV-MPL vaccine 208129 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company has conducted multiple clinical trials to evaluate the vaccine's immunogenicity and safety in different populations.

What phase is HBV-MPL vaccine 208129 in?

HBV-MPL vaccine 208129 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The development program includes both Phase 3 and Phase 1 trials, with all seven completed trials involving a total of 3,092 participants.

What clinical trials is HBV-MPL vaccine 208129 in?

HBV-MPL vaccine 208129 has been studied in seven completed clinical trials. Key trials include NCT00697554 in pre-liver transplant patients, NCT00697749 in healthy volunteers with the HLA-DQ2 genotype, NCT00698061 comparing it to Engerix-B in non-responders, and NCT00699231 in haemodialysis patients.

How does HBV-MPL vaccine 208129 work?

HBV-MPL vaccine 208129 is a vaccine designed to stimulate the immune system to produce a protective response against the Hepatitis B virus. It contains an adjuvant to enhance immunogenicity, and it has been evaluated in randomized, double-blind, active-controlled trials to assess its ability to generate an immune response.

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

No, HBV-MPL vaccine 208129 is not the same as Engerix-B. Engerix-B is a comparator vaccine used in clinical trials to evaluate the immunogenicity and safety of HBV-MPL vaccine 208129. The two vaccines have been directly compared in studies involving non-responders and haemodialysis patients.