Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)
Condition: Rheumatoid Arthritis; Inflammatory Arthritis; Arthritis; Psoriatic Arthritis; Psoriasis; Ankylosing Spondylitis; Enteropathic Arthritis; Crohn's Disease
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Psoriasis
Intervention: Herpes Zoster (HZ) Vaccine; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 617.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the
      Herpes zoster (HZ) vaccine for shingles, Zostavax, in patients over 50 years old with
      arthritis and other diseases who are using anti-tumor necrosis factor (TNF) therapy and who
      have not previously received the vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 50 years of age or older

          -  Must be currently treated with an anti-tumor necrosis factor (TNF) therapy** at the
             time of study drug administration, allowing for small deviations in dosing frequency
             and logistic feasibility (e.g. study visits to occur on a week day). Date of previous
             dose of medication is required. Specifically, meets one of the following: Etanercept
             dose within 9 days (1 week + 2 days), Adalimumab dose within 16 days (2 weeks + 2
             days), Certolizumab Subcutaneous (SC) dose within 16 to 32 days depending on frequency
             schedule (2 weeks + 2 days, or 4 weeks and 4 days), Golimumab Subcutaneous (SC) dose
             within 32 days (4 weeks + 4 days), Golimumab Intravenous (IV) dose within 64 days (9
             weeks + 1 day), Infliximab IV dose within last 64 days (9 weeks + 1 day)

             **any form of biosimilar for the above listed anti-tumor necrosis factor (TNF)
             medications is acceptable

          -  Diagnosis of rheumatoid arthritis or another inflammatory arthritis (Phase 1A); or
             other inflammatory condition (e.g. psoriasis) requiring use of anti-tumor necrosis
             factor (TNF) therapy (Phase 1B and II)

          -  Phase I subjects must test positive for varicella-zoster virus (VZV) antibody
             immunoglobulin G (IgG)

          -  Subjects should have a self-reported history of prior varicella infection (i.e.
             chicken pox) or long-term residence (>30 years) in the continental United States.

          -  Phase IA subjects must not have received any oral or systemic glucocorticoids within
             30 days prior to vaccination. Intra-articular glucocorticoid injections and inhaled
             glucocorticoids within the previous 30 days are acceptable.

          -  Subjects should be on stable doses of all biologic and non-biologic Disease-modifying
             antirheumatic drugs (DMARDs) for a minimum of 30 days prior to vaccination.

          -  Eligible women must be post-menopausal (> 1 year since last menstrual period) or have
             a surgical history of bilateral oophorectomy or hysterectomy.

          -  Subjects should be ambulatory, community dwelling and capable of giving informed
             consent.

        Exclusion Criteria:

          -  Documented varicella-zoster virus (VZV) antibody immunoglobulin G (IgG) negative
             result

          -  Prior use of the zoster vaccine (Zostavax®, Merck)

          -  Glucocorticoids at a prednisone-equivalent daily dose > 10mg/day (for Phase 1B and
             Phase II participants; all systemic glucocorticoid use is prohibited for Phase 1A
             patients)

          -  Any known contraindication to Zostavax® vaccine, including allergy or sensitivity to
             gelatin or any other vaccine component

          -  Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)

          -  Currently receiving radiation or chemotherapy for any type of malignancy

          -  Any current use (within the last 30 days) of acyclovir, valacyclovir, famciclovir, or
             foscarnet

          -  Receipt of any other immunizations within one month before study vaccination (2 weeks
             in the case of inactivated influenza vaccines or other non-replicating immunization
             products [e.g., diphtheria-tetanus (dT), pneumococcal vaccine, hepatitis A vaccine,
             hepatitis B vaccine]), or scheduled within 6 weeks after recruitment.

          -  Active infection or inter-current illness (e.g., urinary tract infection, influenza)

          -  Participated in an investigational study within 1 month prior to study entry

          -  Active drug or alcohol use, dependence, or any other reason that, in the opinion of
             the site investigator, would interfere with the study

          -  Significant underlying illness that would be expected to prevent completion of the
             study (e.g., life-threatening disease likely to limit survival to less than 3 years)

          -  Any other reason that, in the opinion of the site investigator, would interfere with
             required study related evaluations (e.g. uncontrolled comorbidity, life expectancy < 1
             year)

          -  Patients who have household contact with varicella-susceptible pregnant women or
             severely immunosuppressed individuals without history of primary varicella.