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)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00489099

Collaborator

(none)

860

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

860 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Arms and Interventions

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.	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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