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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627340
• Other study ID #: 115918
• Status: Completed
• Phase: Phase 4
• Start date: July 24, 2012
• Est. completion date: December 18, 2013

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: December 18, 2013
• Est. primary completion date: December 18, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™-B vaccine
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	St Albans	Victoria
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Ste-Foy	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	Rotorua
New Zealand	GSK Investigational Site	Takapuna Auckland
New Zealand	GSK Investigational Site	Wellington
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Mishawaka	Indiana
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Stockbridge	Georgia
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)

External Links

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