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A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00489099
First received: June 20, 2007
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.


Condition Intervention Phase
Hepatitis B Infection
Biological: V232 Modified Process Hepatitis B Vaccine: Lot A
Biological: V232 Modified Process Hepatitis B Vaccine: Lot B
Biological: V232 Modified Process Hepatitis B Vaccine: Lot C
Biological: V232 Current Process Hepatitis B Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants with Seroprotection to Hepatitis B Surface Antigen [ Time Frame: 1 month after the third vaccination (Month 7) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers to Hepatitis B Surface Antigen [ Time Frame: 1 month after the third vaccination (Month 7) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants with an Adverse Experience [ Time Frame: Up to 15 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with an Injection-site Adverse Experience [ Time Frame: Up to 15 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with a Systemic Adverse Experience [ Time Frame: Up to 15 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Fever (>=37.8°C, 100.0°F) [ Time Frame: Up to 5 days after any vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 860
Study Start Date: June 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V232 Modified Process Hepatitis B Vaccine: Lot A
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Modified Process Hepatitis B Vaccine: Lot A
Experimental: V232 Modified Process Hepatitis B Vaccine: Lot B
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Modified Process Hepatitis B Vaccine: Lot B
Experimental: V232 Modified Process Hepatitis B Vaccine: Lot C
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Modified Process Hepatitis B Vaccine: Lot C
Active Comparator: V232 Current Process Hepatitis B Vaccine
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Current Process Hepatitis B Vaccine

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In general good health
  • Female participants have a negative pregnancy test just prior to vaccination on Day 1

Exclusion Criteria:

  • History of Hepatitis B Infection or vaccination
  • Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
  • Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
  • Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
  • Participation on prior study using an investigational drug or vaccine in prior 3 months
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
  • Pregnant or nursing women or women planning to become pregnant within the study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489099

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00489099     History of Changes
Other Study ID Numbers: V232-054, 2007_565
Study First Received: June 20, 2007
Last Updated: October 29, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014