Hepatitis BPhase 4NCT01627340
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
A Phase 4 study testing Engerix™-B vaccine in people with Hepatitis B, run by GlaxoSmithKline at 22 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix™-B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 24 Jul 2012to 18 Dec 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States10 sites
GSK Investigational Site
Boise, Idaho, 83642
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Mishawaka, Indiana, 46545
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
Wichita, Kansas, 67207
Canada5 sites
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
Kitchener, Ontario, N2G 1E8
GSK Investigational Site
Québec, Quebec, G1E 7G9
GSK Investigational Site
Ste-Foy, Quebec, G1W 4R4
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
New Zealand4 sites
GSK Investigational Site
Hamilton, 3240
GSK Investigational Site
Rotorua, 3010
GSK Investigational Site
Takapuna Auckland
GSK Investigational Site
Wellington, 6021
Australia3 sites
GSK Investigational Site
Box Hill, Victoria, 3128
GSK Investigational Site
Herston, Queensland, 4029
GSK Investigational Site
St Albans, Victoria, 3021
About this study
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
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
- Being tested
- Engerix™-B vaccine
- Keywords
- Engerix™-B, hepatitis B, adults, Type 2 diabetes mellitus
- Medical subject headings
- Hepatitis B, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix™-B vaccineBiological
Also called HBV
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Group | Experimental | 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. Receives: Biological: Engerix™-B vaccine |
| Control Group | Active comparator | 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. Receives: Biological: Engerix™-B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At one month after the third dose of primary vaccination (Month 7)
Secondary outcomes (5)
Anti-HBs Antibody Concentration
Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: During the entire study period (Month 0 - Month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study start24 Jul 2012
- Primary completion18 Dec 2013
- Study completion18 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627340
- Sponsor's protocol ID
- 115918
- Status last verified
- Jan 2017
- First submitted
- 21 Jun 2012
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 27123743
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01627340
- Acronym / sponsor ID
- 115918
- Conditions
- Hepatitis B
- Keywords
- Engerix™-B, hepatitis B, adults, Type 2 diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2012
- Primary completion
- 18 Dec 2013 (actual)
- Study completion
- 18 Dec 2013 (actual)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Group | Experimental | Biological: Engerix™-B vaccineSubjects 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. |
| Control Group | Active comparator | Biological: Engerix™-B vaccineSubjects 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engerix™-B vaccineAlso: HBV3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | Biological | Control Group, Diabetes Group |
Primary outcome
Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies
Time frame: At one month after the third dose of primary vaccination (Month 7)
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).
5 secondary outcomes
Anti-HBs Antibody Concentration
Time frame: At one month after the third dose of primary vaccination (Month 7)
Number of Subjects Reporting Any Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: During the entire study period (Month 0 - Month 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27123743Van 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Engerix™-B vaccine in people with Hepatitis B, run by GlaxoSmithKline at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies (time frame: At one month after the third dose of primary vaccination (Month 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01627340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.