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 Overview
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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.

Official Title
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A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade

Conditions
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Hepatitis B Infection

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V232 Modified Process Hepatitis B Vaccine: Lot A<br>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<br> <br> |
| Experimental: V232 Modified Process Hepatitis B Vaccine: Lot B<br>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<br> <br> |
| Experimental: V232 Modified Process Hepatitis B Vaccine: Lot C<br>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<br> <br> |
| Active Comparator: V232 Current Process Hepatitis B Vaccine<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |