Clinical trial NCT00489099: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 860
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants with Seroprotection to Hepatitis B Surface Antigen
timeFrame: 1 month after the third vaccination (Month 7)
measure: Geometric Mean Titers to Hepatitis B Surface Antigen
timeFrame: 1 month after the third vaccination (Month 7)
Secondary outcomes:
measure: Percentage of Participants with an Adverse Experience
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants with an Injection-site Adverse Experience
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants with a Systemic Adverse Experience
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants with Fever (>=37.8°C, 100.0°F)
timeFrame: Up to 5 days after any vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.