Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.

Official Title
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An Open-label Study to Assess the Immunogenicity and Safety of GSK Biologicals' Hepatitis B Vaccine, Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Engerix™-B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. A male or female subject aged 20 years and above at the time of screening. Written informed consent obtained from the subject at screening. Subjects diagnosed with type 2 diabetes documented within the past five years, according to the criteria specified by the American Diabetes Association or currently taking any form of anti-diabetic intervention documented by the investigator; or control subjects with no diagnosis or documented history of diabetes, and HbA1c less than 6.5%, as determined by laboratory screening tests. Normal renal function defined as estimated glomerular filtration rate (GFR) ≥ 50 mL/min, estimated through the Modification of Diet in Renal Disease (MDRD) or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, as determined by laboratory screening tests. Seronegative for hepatitis B surface antigen (HBsAg), anti-HBs antibodies and antibodies to hepatitis B core antigen (anti HBc), as determined by laboratory screening tests. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of screening and at Visit 1, and has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series. Exclusion Criteria: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Administration of long-acting immune-modifying drugs within 6 months of the study entry or planned administration at any time during the study period. Administration of a vaccine not foreseen by the study protocol starting from 30 days before each dose of vaccine and ending 30 days after each dose, with the exception of the inactivated influenza vaccine which is allowed at any time during the study if administered at a separate site. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a protocol-specified non-investigational product. Any previous complete or incomplete vaccination against hepatitis B since birth. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex. Advanced heart failure or any other severe clinical condition that significantly reduces the subject's life expectancy. Acute disease and/or fever at the time of enrolment. Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. Any history of alcohol or drug abuse in the past 5 years.

Ages Eligible for Study
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Minimum Age: 20 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Group<br>Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm. | Biological: Engerix™-B vaccine<br>* 3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.<br>* Other names: HBV;|
| Active Comparator: Control Group<br>Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | Biological: Engerix™-B vaccine<br>* 3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.<br>* Other names: HBV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies | A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL). | At one month after the third dose of primary vaccination (Month 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Antibody Concentration | Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL | At one month after the third dose of primary vaccination (Month 7) | 
| Number of Subjects Reporting Any Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity grade. | During the 4-day (Days 0-3) post-vaccination period | 
| Number of Subjects Reporting Any Solicited General Symptoms | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Any fever = oral temperature greater than or equal to (≥) 37.5 degrees Celsius (°C) | During the 4-day (Days 0-3) post-vaccination period | 
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period | 
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. | During the entire study period (Month 0 - Month 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Engerix™-B, hepatitis B, adults, Type 2 diabetes mellitus