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)
March 15, 2017 updated by: Merck Sharp & Dohme LLC
A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
860
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
|
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.
|
|
|
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.
|
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants with Seroprotection to Hepatitis B Surface Antigen
Time Frame: 1 month after the third vaccination (Month 7)
|
1 month after the third vaccination (Month 7)
|
|
Geometric Mean Titers to Hepatitis B Surface Antigen
Time Frame: 1 month after the third vaccination (Month 7)
|
1 month after the third vaccination (Month 7)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Participants with an Adverse Experience
Time Frame: Up to 15 days after any vaccination
|
Up to 15 days after any vaccination
|
|
Percentage of Participants with an Injection-site Adverse Experience
Time Frame: Up to 15 days after any vaccination
|
Up to 15 days after any vaccination
|
|
Percentage of Participants with a Systemic Adverse Experience
Time Frame: Up to 15 days after any vaccination
|
Up to 15 days after any vaccination
|
|
Percentage of Participants with Fever (>=37.8°C, 100.0°F)
Time Frame: Up to 5 days after any vaccination
|
Up to 5 days after any vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
June 20, 2007
First Submitted That Met QC Criteria
June 20, 2007
First Posted (Estimate)
June 21, 2007
Study Record Updates
Last Update Posted (Actual)
March 16, 2017
Last Update Submitted That Met QC Criteria
March 15, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- V232-054
- 2007_565
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.