A Study to Estimate the Immune Response Following a Challenge Dose in Adults (= 50 years old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 296

Inclusion Criteria

1. In general good health based on a medical history taken on Day 1 prior to receiving the study vaccine injection.

2. Received 3 doses of either modified process RECOMBIVAX HB™ or ENGERIX-BTM as per protocol for study V232-059 at least 2 years prior to enrollment in this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known history of previous hepatitis B infection.
2.History of vaccination with any hepatitis B vaccine beyond what was administered in study V232-059.
3.History of febrile illness (oral temperature =37.8ºC or =100.0ºF) within 72 hours prior to study vaccine injection.
4.Known or suspected hypersensitivity to any component of modified process RECOMBIVAX HB™ (e.g., aluminum, yeast).
5.Receipt of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product within 3 months prior to study vaccine injection and until Visit 2
6.Receipt of any licensed inactivated or recombinant vaccine within 14 days prior to study vaccine injection and until Visit 2
7.Receipt of any licensed live-virus vaccine within 30 days prior to study vaccine injection and until Visit 2.
8.Receipt of any investigational drug or other investigational vaccine within 3 months prior to study vaccine injection and until Visit 2.
9.Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids or chemotherapeutic agents). Subjects on systemic corticosteroids should be excluded if they received within 4 weeks prior to study entry, are receiving, or are expected to receive prior to Visit 2 systemic corticosteroid doses >5 mg prednisone (or equivalent) daily for >2 weeks. The exclusion does not apply to topical and inhaled steroids.
10.Known or suspected immune dysfunction that is caused by a medical condition, or other cause. Examples of such conditions include: congenital immune deficiency, human immunodeficiency virus infection, transplantations, leukemia, lymphoma, Hodgkin’s’ disease, multiple myeloma/MGUS, or generalize malignancy. Subjects with a history of cancer who have been cancer free since their participation in the original V232-059 study will be eligible for enrollment.
11. Pregnant women and nursing mothers. A urine pregnancy test will be administered to women of childbearing potential prior to vaccination. For the purposes of this protocol, women of non-childbearing potential are defined as having no menses for one year, post-hysterectomy, post-bilateral tubal ligation, or post-bilateral oophorectomy.
12.Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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