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Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440531
First Posted: February 27, 2007
Last Update Posted: April 13, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

Condition Intervention Phase
Hepatitis B Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental) Biological: Comparator: ENGERIX-B™ (currently licensed product) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) [ Time Frame: 7 months (1 month after third vaccination) ]
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).


Secondary Outcome Measures:
  • The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine) [ Time Frame: 7 months (1 month after third vaccination) ]
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).

  • The Total Number of Participants With One or More Injection-site Adverse Experiences [ Time Frame: Days 1-5 After Any Vaccination ]
  • The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C [ Time Frame: Day 1-5 After Vaccination ]
  • The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences [ Time Frame: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months) ]

Enrollment: 540
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
RECOMBIVAX HB™
Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Experimental: 2
Modified Process Hepatitis B Vaccine
Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Active Comparator: 3
ENGERIX-B™
Biological: Comparator: ENGERIX-B™ (currently licensed product)
ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.

  Eligibility

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:

  • Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

  • Any adult with a history of previous hepatitis B infection
  • A history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
  • Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
  • Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
  • Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
  • Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
  • Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
  • Pregnant women, nursing mothers, and women planning to become pregnant within the study period
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
  Contacts and Locations
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): NCT00440531


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00440531     History of Changes
Other Study ID Numbers: V232-059
2007_516
First Submitted: February 26, 2007
First Posted: February 27, 2007
Results First Submitted: November 11, 2008
Results First Posted: March 31, 2009
Last Update Posted: April 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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