Zostavax in Rheumatoid Arthritis

Brief Title

Safety of Zostavax Vaccination in Rheumatoid Arthritis

Official Title

Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and development of localized herpes zoster lesions

Secondary Outcome

 Immunogenicity

Condition

Rheumatoid Arthritis

Intervention

Zostavax (varicella zoster virus) vaccine

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

January 2012

Completion Date

October 2018

Primary Completion Date

December 2017

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.
      

Gender

All

Ages

50 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Eliza Chakravarty, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01506661

Organization ID

OMRF11-53


Responsible Party

Sponsor

Study Sponsor

Oklahoma Medical Research Foundation


Study Sponsor

Eliza Chakravarty, MD, Principal Investigator, Oklahoma Medical Research Foundation


Verification Date

March 2020