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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00489099

Enrollment

860

Registered

2007-06-21

Start date

2005-06-30

Completion date

2006-05-31

Last updated

2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Infection

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.

Interventions

BIOLOGICALV232 Modified Process Hepatitis B Vaccine: Lot A

BIOLOGICALV232 Modified Process Hepatitis B Vaccine: Lot B

BIOLOGICALV232 Modified Process Hepatitis B Vaccine: Lot C

BIOLOGICALV232 Current Process Hepatitis B Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026