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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis B Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

V232 Modified Process Hepatitis B Vaccine: Lot A

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

V232 Modified Process Hepatitis B Vaccine: Lot B

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

V232 Modified Process Hepatitis B Vaccine: Lot C

Intervention Type BIOLOGICAL

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.

Group Type ACTIVE_COMPARATOR

V232 Current Process Hepatitis B Vaccine

Intervention Type BIOLOGICAL

Interventions

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V232 Modified Process Hepatitis B Vaccine: Lot A

Intervention Type BIOLOGICAL

V232 Modified Process Hepatitis B Vaccine: Lot B

Intervention Type BIOLOGICAL

V232 Modified Process Hepatitis B Vaccine: Lot C

Intervention Type BIOLOGICAL

V232 Current Process Hepatitis B Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes