Systemic Lupus ErythematosusPhase 4NCT01597492

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 4 study testing Belimumab plus Early Vaccination and Belimumab plus Late Vaccination in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc., a GSK Company at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: Belimumab plus Early Vaccination and Belimumab plus Late Vaccination
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 15 sitesUnited States
Study dates: 31 May 2012to 24 Sep 2015
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
Active SLE disease.
Autoantibody-positive.
Have antibodies with titers >1.0 microgram (mcg)/mL to no more than 9 of the 23 serotypes present in the pneumococcal vaccine.
Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.

Who cannot join

Pregnant or nursing.
Have received any prior treatment with belimumab.
Have received a live vaccine within the past 30 days.
Have received a pneumococcal vaccination with the past 5 years.
Have a history of severe allergic reaction to a vaccine, contrast agents (such as those used for x-rays and CT scans), or biological medicines.
Have required management of an infection or have had infections that keep coming back within the past 60 days.

Show all 14Show fewer

Hepatitis B: Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HB surface antigen (HBsAg) and anti-HB core antibody (anti-HBc):
Subjects positive for HBsAg are excluded.
Subjects negative for HBsAg but positive for anti-HBc, regardless of anti-HBs antibody status, are excluded.
Hepatitis C: Positive test for Hepatitis C antibody.
Known human immunodeficiency virus (HIV) infection.
Have current drug or alcohol abuse or dependence.
Have a Grade 3/4 immunoglobulin (Ig)G deficiency (IgG level <400 milligrams [mg]/ deciliter [dL]) or IgA deficiency (IgA level <10 mg/dL).
Subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or suicidal ideation with some intent to act in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

GSK Investigational Site
Austin, Texas, 78731
GSK Investigational Site
Austin, Texas, 78758
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Birmingham, Alabama, 35249
GSK Investigational Site
Burlington, Vermont, 05401
GSK Investigational Site
Cumberland, Maryland, 21502
GSK Investigational Site
Duncansville, Pennsylvania, 16635
GSK Investigational Site
Hagerstown, Maryland, 21740
GSK Investigational Site
Houston, Texas, 77090
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Paradise Valley, Arizona, 85253
GSK Investigational Site
Seattle, Washington, 98133
GSK Investigational Site
Shreveport, Louisiana, 71103
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Toledo, Ohio, 43623

Other trials in United States

About this study

Official title: A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).

Read the detailed description

All patients in this study will receive belimumab plus standard therapy for SLE and vaccination against pneumococcus. Patients will be randomized to receive pneumococcal vaccination either 4 weeks prior (early vaccination group) or 24 weeks after (late vaccination group) their first belimumab dose. Vaccine response will be assessed 4 weeks after vaccine administration.

Conditions: Systemic Lupus Erythematosus
Being tested: Belimumab plus Early Vaccination, Belimumab plus Late Vaccination
Keywords: Antibodies, Vaccines, SLE, Immune System Diseases, Biological Therapy, Autoimmune Diseases, Pneumococcal Vaccines, Lupus, Immunoglobulins, Vaccination, Belimumab, Biological Agents, Immunization
Medical subject headings: Lupus Erythematosus, Systemic, Immune System Diseases, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Belimumab plus Early VaccinationBiological
Also called BENLYSTA™
Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 28, 42, 56, and every 28 days thereafter through Week 32 (9 doses). Pneumococcal vaccination is administered 4 weeks prior to the first dose of belimumab.
Belimumab plus Late VaccinationBiological
Also called BENLYSTA™
Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 0, 14, 28, and then every 28 days thereafter through Week 28 (9 doses). Pneumococcal vaccination is administered 24 weeks after the first dose of belimumab.

Study groups in NCT01597492
Study group	Role	What they receive
Belimumab plus Early Vaccination	Experimental	Belimumab plus Early Vaccination Receives: Biological: Belimumab plus Early Vaccination
Belimumab plus Late Vaccination	Experimental	Belimumab plus Late Vaccination Receives: Biological: Belimumab plus Late Vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination
A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28.
Measured: Four weeks after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 201224 Sep 2015

First posted14 May 2012 (estimated)
Study start31 May 2012
Primary completion1 Sep 2015
Study completion24 Sep 2015

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 Systemic Lupus ErythematosusStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01597492
Sponsor's protocol ID: 115470
Other IDs: HGS1006-C1117
Status last verified: Jul 2018
First submitted: 8 May 2012
Last updated: 16 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Azoicai T, Antoniu S, Caruntu ID, Azoicai D, Antohe I, Gavrilovici C. Belimumab and antipneumococcal vaccination in patients with systemic lupus erythematosus. Expert Rev Clin Immunol. 2018 Mar;14(3):175-177. doi: 10.1080/1744666X.2018.1429269. Epub 2018 Jan 22.
PubMed 29336179

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT01597492
Acronym / sponsor ID: 115470
Conditions: Systemic Lupus Erythematosus
Keywords: Antibodies, Vaccines, SLE, Immune System Diseases, Biological Therapy, Autoimmune Diseases, Pneumococcal Vaccines, Lupus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Human Genome Sciences Inc., a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 31 May 2012 (actual)
Primary completion: 1 Sep 2015 (actual)
Study completion: 24 Sep 2015 (actual)
First posted: 14 May 2012 (estimated)
Results: Posted 25 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Belimumab plus Early Vaccination	Experimental	Biological: Belimumab plus Early VaccinationBelimumab plus Early Vaccination
Belimumab plus Late Vaccination	Experimental	Biological: Belimumab plus Late VaccinationBelimumab plus Late Vaccination

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
Active SLE disease.
Autoantibody-positive.
Have antibodies with titers >1.0 microgram (mcg)/mL to no more than 9 of the 23 serotypes present in the pneumococcal vaccine.
Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.

Key exclusion criteria (14 listed)

Pregnant or nursing.
Have received any prior treatment with belimumab.
Have received a live vaccine within the past 30 days.
Have received a pneumococcal vaccination with the past 5 years.
Have a history of severe allergic reaction to a vaccine, contrast agents (such as those used for x-rays and CT scans), or biological medicines.

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
Belimumab plus Early VaccinationAlso: BENLYSTA™Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 28, 42, 56, and every 28 days thereafter through Week 32 (9 doses). Pneumococcal vaccination is administered 4 weeks prior to the first dose of belimumab.	Biological	Belimumab plus Early Vaccination
Belimumab plus Late VaccinationAlso: BENLYSTA™Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 0, 14, 28, and then every 28 days thereafter through Week 28 (9 doses). Pneumococcal vaccination is administered 24 weeks after the first dose of belimumab.	Biological	Belimumab plus Late Vaccination

Primary outcome

Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination
Time frame: Four weeks after vaccination
A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28.

Results and safety

Results posted to the registry on 25 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Belimumab Plus Early Vaccination	34	28
Belimumab Plus Late Vaccination	45	41

Primary outcome: Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination

Time frame: Four weeks after vaccination. Number. Unit: Participants

Measure	Belimumab Plus Early Vaccination n = 33	Belimumab Plus Late Vaccination n = 41
Value	32	40

Population analysed: As-treated Population: all participants who received at least one dose of belimumab. All analyses of vaccine titers were performed on the As-treated Population.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 8 weeks following administration of the last dose of belimumab).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belimumab Plus Early Vaccination	4 of 34 (11.8%)	21 of 34 (61.8%)	Not reported
Belimumab Plus Late Vaccination	3 of 45 (6.7%)	32 of 45 (71.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29336179Azoicai T, Antoniu S, Caruntu ID, Azoicai D, Antohe I, Gavrilovici C. Belimumab and antipneumococcal vaccination in patients with systemic lupus erythematosus. Expert Rev Clin Immunol. 2018 Mar;14(3):175-177. doi: 10.1080/1744666X.2018.1429269. Epub 2018 Jan 22.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Systemic Lupus Erythematosus

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RecruitingPhase 4
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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

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 14 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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 25 Jul 2016). 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 Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination (time frame: Four weeks after vaccination). 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 NCT01597492, 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 16 Aug 2018.