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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01251276
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : August 28, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Modified Process Hepatitis B Vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 30, 2010
Primary Completion Date : April 12, 2011
Study Completion Date : April 12, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Modified Process Hepatitis B Vaccine in Base Study
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
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
Other Name: HBVaxPro
Experimental: ENGERIX-B™ Vaccine in Base Study
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
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
Other Name: HBVaxPro



Primary Outcome Measures :
  1. Percentage of Seroresponders Before and After the Challenge Vaccination [ Time Frame: 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 :
  1. Percentage of Participants With One or More Adverse Experiences [ Time Frame: 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.

  2. Percentage of Participants Who Discontinued the Study Due to an Adverse Experience [ Time Frame: Up to Month 7 ]
    The percentage of participants who discontinued the study due to an adverse experience was assessed.

  3. Percentage of Participants With One or More Injection-site Adverse Experiences [ Time Frame: Up to Day 15 after challenge dose ]
    The percentage of participants with one or more injection-site adverse experiences was assessed.

  4. Percentage of Participants With One or More Systemic Adverse Experiences [ Time Frame: Up to Day 15 after challenge dose ]
    The percentage of participants with one or more systemic adverse experiences was assessed.

  5. Percentage of Participants With One or More Serious Adverse Experiences [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251276


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01251276     History of Changes
Other Study ID Numbers: V232-059-10
rHB01C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
2009-016721-33 ( EudraCT Number )
First Posted: December 1, 2010    Key Record Dates
Results First Posted: August 28, 2017
Last Update Posted: November 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs