Rheumatoid ArthritisPhase 1NCT01506661
Safety of Zostavax Vaccination in Rheumatoid Arthritis
A Phase 1 study testing Zostavax (varicella zoster virus) vaccine in people with Rheumatoid Arthritis and Varicella Zoster, run by Oklahoma Medical Research Foundation at 1 site in United States.
Trial summary
Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV) that usually occurs decades following initial exposure. The risk of developing shingles increases with age. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Varicella Zoster
- What is being tested?
- Zostavax (varicella zoster virus) 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
- Jan 2012to Oct 2018
- 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 80 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 RA according to ACR criteria for > 1 year, or healthy control subject
- Stable, mild disease activity as defined by a DAS28 score of 4.0
- Current medical treatment for RA has been stable for 4 weeks prior to screening
- Acceptable immunosuppressive medications are limited to Prednisone ≤ 10 mg daily Methotrexate ≤ 20 mg weekly Hydroxychloroquine ≤ 6.5 mg/kg daily Any TNF inhibitor
- 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
- History of herpes zoster reactivation (shingles) within 5 years of enrollment
- Received any vaccine within 6 weeks
- Known Hepatitis B, C or HIV virus infection
- History of drug or alcohol abuse within 1 year
- Rituximab therapy within 2 years of screening
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- Cyclophosphamide within 6 months of screening
- Biologic therapy: TNF inhibitors with longer half-lives (infliximab, golimumab, etc), or other non-TNF biologic therapies (IL-1 or IL-6 inhibition, or CTLA-4Ig)
- 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
- DAS28 > 4
- Anticipation of need to increase level of immunosuppression or add biologic therapy for 6 months following dosing.
- 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.
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: Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis
Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV) that usually occurs decades following initial exposure. The risk of developing shingles increases with age. Shingles presents as a painful, itchy blistering rash that usually involves a single portion of the skin and lasts about 7-10 days. The risk of developing shingles increases with age in healthy people, and has been shown in some studies to be increased in people with rheumatoid arthritis and other autoimmune diseases.
Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by the FDA for the prevention of Shingles among people 60 years and older, and is now approved for use in people aged 50 years and older. Because rheumatoid arthritis and some of the medications used to treat rheumatoid arthritis can impair the body's immune system, it is not known how much of an immune response can be generated in people with rheumatoid arthritis.
The goals of this study are to measure the immune response after standard vaccination with Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune systems. All participants will be 50 years old or older, and subjects with rheumatoid arthritis will not be eligible if they are taking certain biologic medications, including TNF inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid arthritis will all receive a single vaccination with Zostavax, then will be followed for 12 weeks to assess the immune response and for the development of local rash or other potential side effects.
- Conditions
- Rheumatoid Arthritis, Varicella Zoster
- Being tested
- Zostavax (varicella zoster virus) vaccine
- Keywords
- Rheumatoid arthritis, vaccination, immune response, varicella zoster
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zostavax (varicella zoster virus) vaccineDrug
Standard vaccination protocol for Zostavax will be utilized. 0.65 ml (19,400 plaque forming units) Zostavax will be administered subcutaneously once at the baseline visit
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Experimental | 10 subjects with mild rheumatoid arthritis aged 50 years and older will be enrolled and will receive a single dose of Zostavax vaccine. Receives: Drug: Zostavax (varicella zoster virus) vaccine |
| Healthy Subjects | Active comparator | 10 healthy subjects aged 50 years or older who have not been previously immunized, will receive a single injection of Zostavax. Receives: Drug: Zostavax (varicella zoster virus) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and development of localized herpes zoster lesions
The primary outcome of the study is assessment of adverse events, including injection site reactions and development of zoster-like lesions, following vaccination in subjects with RA compared to healthy subjects
Measured: 12 weeks
Secondary outcomes (1)
Immunogenicity
The secondary objective of the study is immunogenicity. Specifically, the change from baseline in varicella-zoster virus-specific cell mediated immunity (assessed by IFN-g ELISpot) between subjects with RA and healthy subjects will be compared.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Model description
- Pilot study
- 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
- Investigators
- Eliza Chakravarty, MD, Principal investigator, Oklahoma Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506661
- Sponsor's protocol ID
- OMRF11-53
- Status last verified
- Mar 2020
- First submitted
- 5 Jan 2012
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01506661
- Acronym / sponsor ID
- OMRF11-53
- Conditions
- Rheumatoid Arthritis, Varicella Zoster
- Keywords
- Rheumatoid arthritis, vaccination, immune response, varicella zoster
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oklahoma Medical Research FoundationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 10 Jan 2012 (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.
Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV) that usually occurs decades following initial exposure. The risk of developing shingles increases with age. Shingles presents as a painful, itchy blistering rash that usually involves a single portion of the skin and lasts about 7-10 days. The risk of developing shingles increases with age in healthy people, and has been shown in some studies to be increased in people with rheumatoid arthritis and other autoimmune diseases.
Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by the FDA for the prevention of Shingles among people 60 years and older, and is now approved for use in people aged 50 years and older. Because rheumatoid arthritis and some of the medications used to treat rheumatoid arthritis can impair the body's immune system, it is not known how much of an immune response can be generated in people with rheumatoid arthritis.
The goals of this study are to measure the immune response after standard vaccination with Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune systems. All participants will be 50 years old or older, and subjects with rheumatoid arthritis will not be eligible if they are taking certain biologic medications, including TNF inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid arthritis will all receive a single vaccination with Zostavax, then will be followed for 12 weeks to assess the immune response and for the development of local rash or other potential side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | Experimental | Drug: Zostavax (varicella zoster virus) vaccine10 subjects with mild rheumatoid arthritis aged 50 years and older will be enrolled and will receive a single dose of Zostavax vaccine. |
| Healthy Subjects | Active comparator | Drug: Zostavax (varicella zoster virus) vaccine10 healthy subjects aged 50 years or older who have not been previously immunized, will receive a single injection of Zostavax. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 50 years
- Willing and able to provide written informed consent
- History of primary varicella vaccination or positive VZV IgG antibodies
- Diagnosis of RA according to ACR criteria for > 1 year, or healthy control subject
- Stable, mild disease activity as defined by a DAS28 score of 4.0
Key exclusion criteria (23 listed)
- History of receiving any VZV-containing vaccine
- History of herpes zoster reactivation (shingles) within 5 years of enrollment
- Received any vaccine within 6 weeks
- Known Hepatitis B, C or HIV virus infection
- History of drug or alcohol abuse within 1 year
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 (varicella zoster virus) vaccineStandard vaccination protocol for Zostavax will be utilized. 0.65 ml (19,400 plaque forming units) Zostavax will be administered subcutaneously once at the baseline visit | Drug | Healthy Subjects, Rheumatoid Arthritis |
Primary outcome
Safety and development of localized herpes zoster lesions
Time frame: 12 weeks
The primary outcome of the study is assessment of adverse events, including injection site reactions and development of zoster-like lesions, following vaccination in subjects with RA compared to healthy subjects
1 secondary outcome
Immunogenicity
Time frame: 6 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 6 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Eliza Chakravarty, MD principal investigator
Oklahoma Medical Research Foundation
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 (varicella zoster virus) vaccine in people with Rheumatoid Arthritis and Varicella Zoster, 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 8 inclusion and 23 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 6 Mar 2020. 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?
Safety and development of localized herpes zoster lesions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2020.