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

Hepatitis B Clinical Trial

Official title:

A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251276
• Other study ID #: V232-059-10
• Secondary ID: rHB01C2006-00364
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2010
• Est. completion date: April 12, 2011

Study information

• Verified date: August 2022
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: April 12, 2011
• Est. primary completion date: April 12, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

References & Publications (1)

Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged = 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Seroresponders Before and After the Challenge Vaccination	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.	Predose (Day 1) and 1 month after challenge dose (Month 1)
Secondary	Percentage of Participants With One or More Adverse Experiences	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.	Up to Day 15 after challenge dose
Secondary	Percentage of Participants Who Discontinued the Study Due to an Adverse Experience	The percentage of participants who discontinued the study due to an adverse experience was assessed.	Up to Month 7
Secondary	Percentage of Participants With One or More Injection-site Adverse Experiences	The percentage of participants with one or more injection-site adverse experiences was assessed.	Up to Day 15 after challenge dose
Secondary	Percentage of Participants With One or More Systemic Adverse Experiences	The percentage of participants with one or more systemic adverse experiences was assessed.	Up to Day 15 after challenge dose
Secondary	Percentage of Participants With One or More Serious Adverse Experiences	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.	Up to Month 1 after challenge dose