Hepatitis B Challenge Dose in Adults (V232-059-10)

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Modified Process Hepatitis B Vaccine

• Registration Number: NCT01251276
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-23
• Study Start: 2010-11-30
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-01
• Primary Completion: 2011-04-12
• Study Completion: 2011-04-12
• Results First Submitted: 2017-07-26
• Results First Submitted QC: 2017-07-26
• Results First Posted: 2017-08-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• In general good health based on a medical history.
• Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Exclusion Criteria

• Known history of previous Hepatitis B infection.
• History of vaccination with any Hepatitis B vaccine within the last 2 years.
• History of febrile illness.
• Known or suspected hypersensitivity to any component of HBVaxPro.
• Receipt of medication / vaccine that may interfere with study assessments.
• Known or suspected immune impairment.
• Pregnant women and nursing mothers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Process Hepatitis B Vaccine in Base Study	Modified Process Hepatitis B Vaccine	Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
ENGERIX-B™ Vaccine in Base Study	Modified Process Hepatitis B Vaccine	Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

Primary Outcome Measures

Name	Time	Method
Percentage of Seroresponders Before and After the Challenge Vaccination	Predose (Day 1) and 1 month after challenge dose (Month 1)	A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With One or More Systemic Adverse Experiences	Up to Day 15 after challenge dose	The percentage of participants with one or more systemic adverse experiences was assessed.
Percentage of Participants With One or More Serious Adverse Experiences	Up to Month 1 after challenge dose	A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.
Percentage of Participants Who Discontinued the Study Due to an Adverse Experience	Up to Month 7	The percentage of participants who discontinued the study due to an adverse experience was assessed.
Percentage of Participants With One or More Injection-site Adverse Experiences	Up to Day 15 after challenge dose	The percentage of participants with one or more injection-site adverse experiences was assessed.
Percentage of Participants With One or More Adverse Experiences	Up to Day 15 after challenge dose	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.