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Recombinant Hepatitis B Virus Vaccine

Phase 3

Hepatitis B | Vaccine | Other |Roche Holding AG|Last Updated: Jan 31, 2019

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Dec 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

Recombinant Hepatitis B Virus Vaccine · 1 trial · 2 indications

Phase 3 1
NCT02003703Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .Hepatitis B
COMPLETED107 Analytics
PHASE3COMPLETED
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Serologic Response
4-8 weeks After Exposure

Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.

Secondary Endpoints

Local Reactions to Vaccine
One Week after Exposure
Systemic Reactions to the Vaccine
One Week after Exposure
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Recombinant Hepatitis B Virus Vaccine (High Dose)EXPERIMENTALPatients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.
Recombinant Hepatitis B Virus Vaccine (Standard Dose)ACTIVE_COMPARATORPatients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.

Interventions

NameTypeDescription
Recombinant Hepatitis B Virus VaccineBIOLOGICAL -
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Eligibility Criteria

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

Inclusion Criteria: * Older than 18 years of age. * Patients infected with Human Immunodeficiency Virus (HIV) * Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a he...

Countries:Chile
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