Systemic Lupus ErythematosusPhase 1NCT01474720
Zostavax in Systemic Lupus Erythematosus
A Phase 1 study testing Zostavax vaccine in people with Systemic Lupus Erythematosus, run by Oklahoma Medical Research Foundation at 1 site in United States.
Trial summary
Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Zostavax vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Willing and able to provide written informed consent
- History of primary varicella vaccination or positive VZV IgG antibodies
- Diagnosis of SLE according to ACR criteria for > 1 year; or healthy control subject
- Stable, mild disease activity as defined by a clinical SLEDAI score ≤ 4
- Current medical treatment for SLE has been stable for 4 weeks prior to screening
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- Acceptable immunosuppressive medications are limited to
- Prednisone ≤ 10 mg daily
- Methotrexate ≤ 20 mg weekly
- Azathioprine ≤ 150 mg daily
- Hydroxychloroquine ≤ 6.5 mg/kg daily
- Female subjects of childbearing potential and non-sterile males must agree to use acceptable form of contraception for the duration of the study
Who cannot join
- History of receiving any VZV-containing vaccine (primary varicella or zoster)
- History of herpes zoster reactivation within 5 years prior to enrollment
- Received any live vaccine within 6 weeks or inactivated/recombinant vaccine within 2 weeks of enrollment
- Known Hepatitis B, C or HIV virus infection
- History of drug or alcohol abuse within 1 year of screening
- Rituximab therapy within 2 years of screening
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- Cyclophosphamide within 6 months of screening
- Biologic therapy (TNF inhibitors, CTLA-4Ig, etc.) within 6 months of screening
- Use of mycophenolate mofetil within 3 months of screening
- History of receiving immunoglobulin or other blood product within 3 months of screening
- Allergic reaction, intolerance or other contraindication to use of famciclovir.
- Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 3 months of screening; or expects to receive another experimental/investigational agent within 6 months post immunization.
- Pregnant or lactating women
- Unwilling to use acceptable method of contraception for the duration of the study
- WBC <3.0; ANC <1500; CD4+ <200
- Proteinuria >1.5 mg/day
- Impaired renal function defined by serum Cr >1.5
- Transaminases > 2x upper limit of normal
- Clinical SLEDAI > 4
- Active lupus nephritis or cerebritis
- History of neoplastic disease within 5 years of screening, except for completely excised non-melanoma cancer of the skin or in-situ carcinoma of the uterine cervix.
- History of any hematological malignancy, current bleeding disorder or taking anticoagulant medication (heparin or warfarin).
- Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Has a moderate to severe acute illness and/or oral temperature greater or equal to 100.0oF, within 72 hours prior to vaccination (this may result in temporary delay of vaccination).
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
About this study
Official title: Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus
Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox.
The investigators propose to study the immune response to commercially available Zostavax vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that seen in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the study are those felt to be safe according to Centers for Disease Control guidelines.
Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to receive a single, standard dose of Zostavax. Blood samples and physical examination will be performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants will receive active vaccine, there is no placebo group.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Zostavax vaccine
- Keywords
- Systemic Lupus Erythematosus, Lupus, SLE, Zostavax, shingles
- Medical subject headings
- Lupus Erythematosus, Systemic, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zostavax vaccineDrug
Commercially available Zostavax vaccine will be administered subcutaneously according to package insert guidelines. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV.
| Study group | Role | What they receive |
|---|---|---|
| SLE patients | Experimental | Subjects with mild SLE over age 50 years will receive open-label Zostavax vaccine. Receives: Drug: Zostavax vaccine |
| Healthy subjects | Active comparator | Healthy subjects aged 50 years and older without any history of autoimmune disease will receive zostavax vaccine. Immune responses to varicella zoster virus and adverse events will be compared to those seen in SLE patients Receives: Drug: Zostavax vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-mediated immune response to varicella at 12 weeks following vaccination
Peripheral blood will be drawn at baseline, then at 2,6, and 12 weeks following vaccination. Peripheral blood mononuclear cells will be assessed for measures of varicella-zoster specific immunity.
Measured: 12 weeks
Secondary outcomes (2)
Antibody response to Zostavax vaccination
Varicella specific IgG antibodies will be compared between baseline and 12 weeks post vaccination.
Measured: 12 weeks
Adverse events
The development of adverse events, particularly injection site reactions or rash near the injection site will be tabulated and compared between SLE and healthy control groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma Medical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474720
- Sponsor's protocol ID
- OMRF 11-45
- Status last verified
- Nov 2011
- First submitted
- 15 Nov 2011
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guthridge JM, Cogman A, Merrill JT, Macwana S, Bean KM, Powe T, Roberts V, James JA, Chakravarty EF. Herpes zoster vaccination in SLE: a pilot study of immunogenicity. J Rheumatol. 2013 Nov;40(11):1875-80. doi: 10.3899/jrheum.130170. Epub 2013 Sep 15.
PubMed 24037550
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01474720
- Acronym / sponsor ID
- OMRF 11-45
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Lupus, SLE, Zostavax, shingles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oklahoma Medical Research FoundationUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox.
The investigators propose to study the immune response to commercially available Zostavax vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that seen in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the study are those felt to be safe according to Centers for Disease Control guidelines.
Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to receive a single, standard dose of Zostavax. Blood samples and physical examination will be performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants will receive active vaccine, there is no placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patients | Experimental | Drug: Zostavax vaccineSubjects with mild SLE over age 50 years will receive open-label Zostavax vaccine. |
| Healthy subjects | Active comparator | Drug: Zostavax vaccineHealthy subjects aged 50 years and older without any history of autoimmune disease will receive zostavax vaccine. Immune responses to varicella zoster virus and adverse events will be compared to those seen in SLE patients |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 50 years
- Willing and able to provide written informed consent
- History of primary varicella vaccination or positive VZV IgG antibodies
- Diagnosis of SLE according to ACR criteria for > 1 year; or healthy control subject
- Stable, mild disease activity as defined by a clinical SLEDAI score ≤ 4
Key exclusion criteria (24 listed)
- History of receiving any VZV-containing vaccine (primary varicella or zoster)
- History of herpes zoster reactivation within 5 years prior to enrollment
- Received any live vaccine within 6 weeks or inactivated/recombinant vaccine within 2 weeks of enrollment
- Known Hepatitis B, C or HIV virus infection
- History of drug or alcohol abuse within 1 year of screening
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 |
|---|---|---|
| Zostavax vaccineCommercially available Zostavax vaccine will be administered subcutaneously according to package insert guidelines. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV. | Drug | Healthy subjects, SLE patients |
Primary outcome
Cell-mediated immune response to varicella at 12 weeks following vaccination
Time frame: 12 weeks
Peripheral blood will be drawn at baseline, then at 2,6, and 12 weeks following vaccination. Peripheral blood mononuclear cells will be assessed for measures of varicella-zoster specific immunity.
2 secondary outcomes
Antibody response to Zostavax vaccination
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Derived from this study: PubMed 24037550Guthridge JM, Cogman A, Merrill JT, Macwana S, Bean KM, Powe T, Roberts V, James JA, Chakravarty EF. Herpes zoster vaccination in SLE: a pilot study of immunogenicity. J Rheumatol. 2013 Nov;40(11):1875-80. doi: 10.3899/jrheum.130170. Epub 2013 Sep 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zostavax vaccine in people with Systemic Lupus Erythematosus, run by Oklahoma Medical Research Foundation at 1 site in United States.
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 12 inclusion and 24 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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cell-mediated immune response to varicella at 12 weeks following vaccination (time frame: 12 weeks). 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 NCT01474720, 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 17 Sep 2013; AzTrials last refreshed its copy on 3 Nov 2026.