Safety of Zostavax Vaccination in Rheumatoid Arthritis

NCT01506661 | Completed Phase 1 DMC

• 1 other identifier: OMRF11-53
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Varicella Zoster

Keywords

Rheumatoid arthritis; vaccination; immune response; varicella zoster

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• Immunogenicity

  6 weeks

Study Arms (2)

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.

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.

Drug: Zostavax (varicella zoster virus) vaccine

Interventions

Zostavax (varicella zoster virus) vaccine DRUG

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

Healthy Subjects; Rheumatoid Arthritis

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma Medical Research Foundation: lead

Study Sites (1)

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Herpes Zoster Vaccine; Vaccines

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Biological Products; Complex Mixtures

Study Officials

• Eliza Chakravarty, MD

  Oklahoma Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 10, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: October 1, 2018
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)