Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

Study Overview
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Brief Summary
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The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

Official Title
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A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
* Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
* Biological: Comparator: ENGERIX-B™ (currently licensed product)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female older adults greater than or equal to 50 years of age Exclusion Criteria: Any adult with a history of previous hepatitis B infection A history of vaccination with any hepatitis B vaccine Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF) Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast) Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids Pregnant women, nursing mothers, and women planning to become pregnant within the study period Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Ages Eligible for Study
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Minimum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>RECOMBIVAX HB™ | Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)<br>* RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.<br>|
| Experimental: 2<br>Modified Process Hepatitis B Vaccine | Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)<br>* Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.<br>|
| Active Comparator: 3<br>ENGERIX-B™ | Biological: Comparator: ENGERIX-B™ (currently licensed product)<br>* ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination). | 7 months (1 month after third vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine) | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination). | 7 months (1 month after third vaccination) | 
| The Total Number of Participants With One or More Injection-site Adverse Experiences |  | Days 1-5 After Any Vaccination | 
| The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C |  | Day 1-5 After Vaccination | 
| The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences |  | During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months) |