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Recombinant MPL- adjuvanted hepatitis B vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 16, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

Recombinant MPL- adjuvanted hepatitis B vaccine · 1 trial · 1 indication

Phase 3 1
NCT00697931Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-RespondersHepatitis B
COMPLETED116 Analytics
PHASE3COMPLETED
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HBs antibody concentrations
At month 7

Secondary Endpoints

Anti-HBs antibody concentrations
At months 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
4-day follow-up after vaccination
Occurrence, intensity and relationship 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 -

Interventions

NameTypeDescription
Recombinant MPL- adjuvanted hepatitis B vaccineBIOLOGICALIntramuscular injection, 3 doses
Engerix™-BBIOLOGICALIntramuscular injection, 3 doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age: older than 18 years of age. * Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to ...

Countries:Belgium
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Frequently asked questions about Recombinant MPL- adjuvanted hepatitis B vaccine

What is Recombinant MPL- adjuvanted hepatitis B vaccine used for?

Recombinant MPL- adjuvanted hepatitis B vaccine is used for hepatitis B. It is an investigational vaccine being developed by GSK plc (GSK) and is currently in Phase 3 clinical development. The vaccine is designed to provide immunity against hepatitis B infection.

Who makes Recombinant MPL- adjuvanted hepatitis B vaccine?

Recombinant MPL- adjuvanted hepatitis B vaccine is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adult non-responders to existing hepatitis B vaccines.

What phase is Recombinant MPL- adjuvanted hepatitis B vaccine in?

Recombinant MPL- adjuvanted hepatitis B vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine is being studied for the prevention of hepatitis B.

What clinical trials is Recombinant MPL- adjuvanted hepatitis B vaccine in?

Recombinant MPL- adjuvanted hepatitis B vaccine has one completed Phase 3 trial, NCT00697931, titled 'Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders'. The trial enrolled 116 participants in Belgium and compared the vaccine to an active control.

Is Recombinant MPL- adjuvanted hepatitis B vaccine the same as Engerix-B?

Recombinant MPL- adjuvanted hepatitis B vaccine is not the same as Engerix-B. In the clinical trial NCT00697931, the vaccine was compared against Engerix-B as an active control. The investigational vaccine includes an MPL adjuvant, while Engerix-B is a standard recombinant hepatitis B vaccine.

How does Recombinant MPL- adjuvanted hepatitis B vaccine work?

Recombinant MPL- adjuvanted hepatitis B vaccine is designed to stimulate an immune response against hepatitis B. It contains a recombinant hepatitis B surface antigen combined with an MPL adjuvant, which is intended to enhance the body's immune response. The vaccine is being studied in adults who did not respond to previous hepatitis B vaccination.