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)
A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
2 other identifiers
interventional
860
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedMarch 16, 2017
March 1, 2017
11 months
June 20, 2007
March 15, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants with Seroprotection to Hepatitis B Surface Antigen
1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen
1 month after the third vaccination (Month 7)
Secondary Outcomes (4)
Percentage of Participants with an Adverse Experience
Up to 15 days after any vaccination
Percentage of Participants with an Injection-site Adverse Experience
Up to 15 days after any vaccination
Percentage of Participants with a Systemic Adverse Experience
Up to 15 days after any vaccination
Percentage of Participants with Fever (>=37.8°C, 100.0°F)
Up to 5 days after any vaccination
Study Arms (4)
V232 Modified Process Hepatitis B Vaccine: Lot A
EXPERIMENTALRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Modified Process Hepatitis B Vaccine: Lot B
EXPERIMENTALRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Modified Process Hepatitis B Vaccine: Lot C
EXPERIMENTALRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Current Process Hepatitis B Vaccine
ACTIVE COMPARATORRecombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Interventions
Eligibility Criteria
You may qualify if:
- In general good health
- Female participants have a negative pregnancy test just prior to vaccination on Day 1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Van Damme P, Minervini G, Liss CL, McCarson B, Vesikari T, Boslego JW, Bhuyan PK. Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults. Hum Vaccin. 2009 Feb;5(2):92-7. doi: 10.4161/hv.5.2.6587. Epub 2009 Feb 14.
PMID: 18690015BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 21, 2007
Study Start
June 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
March 16, 2017
Record last verified: 2017-03