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Safety of Zostavax Vaccination in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis, Varicella Zoster

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zostavax (varicella zoster virus) vaccine
Sponsored by
Oklahoma Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, vaccination, immune response, varicella zoster

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Oklahoma Medical Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rheumatoid Arthritis

Healthy Subjects

Arm Description

10 subjects with mild rheumatoid arthritis aged 50 years and older will be enrolled and will receive a single dose of Zostavax vaccine.

10 healthy subjects aged 50 years or older who have not been previously immunized, will receive a single injection of Zostavax.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 5, 2012
Last Updated
March 4, 2020
Sponsor
Oklahoma Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01506661
Brief Title
Safety of Zostavax Vaccination in Rheumatoid Arthritis
Official Title
Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma Medical Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Varicella Zoster
Keywords
Rheumatoid arthritis, vaccination, immune response, varicella zoster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rheumatoid Arthritis
Arm Type
Experimental
Arm Description
10 subjects with mild rheumatoid arthritis aged 50 years and older will be enrolled and will receive a single dose of Zostavax vaccine.
Arm Title
Healthy Subjects
Arm Type
Active Comparator
Arm Description
10 healthy subjects aged 50 years or older who have not been previously immunized, will receive a single injection of Zostavax.
Intervention Type
Drug
Intervention Name(s)
Zostavax (varicella zoster virus) vaccine
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and development of localized herpes zoster lesions
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliza Chakravarty, MD
Organizational Affiliation
Oklahoma Medical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety of Zostavax Vaccination in Rheumatoid Arthritis

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