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

NCT ID: NCT01627340

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 667 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-24
• Study Completion Date: 2013-12-18

Brief 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.

Conditions

Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diabetes Group

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.

Group Type: EXPERIMENTAL

Engerix™-B vaccine

Intervention Type: BIOLOGICAL

3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Engerix™-B vaccine

Intervention Type: BIOLOGICAL

3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Interventions

Engerix™-B vaccine

3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

HBV

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Boise, Idaho, United States

GSK Investigational Site

Mishawaka, Indiana, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Endwell, New York, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Wenatchee, Washington, United States

GSK Investigational Site

Herston, Queensland, Australia

GSK Investigational Site

Box Hill, Victoria, Australia

GSK Investigational Site

St Albans, Victoria, Australia

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Kitchener, Ontario, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Ste-Foy, Quebec, Canada

GSK Investigational Site

Hamilton, , New Zealand

GSK Investigational Site

Rotorua, , New Zealand

GSK Investigational Site

Takapuna Auckland, , New Zealand

GSK Investigational Site

Wellington, , New Zealand

Countries

United States; Australia; Canada; New Zealand

References

Van Der Meeren O, Peterson JT, Dionne M, Beasley R, Ebeling PR, Ferguson M, Nissen MD, Rheault P, Simpson RW, De Ridder M, Crasta PD, Miller JM, Trofa AF. Prospective clinical trial of hepatitis B vaccination in adults with and without type-2 diabetes mellitus. Hum Vaccin Immunother. 2016 Aug 2;12(8):2197-2203. doi: 10.1080/21645515.2016.1164362. Epub 2016 Apr 28.

Reference Type: DERIVED

PMID: 27123743 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

115918

Identifier Type: -

Identifier Source: org_study_id