Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Oregon Health and Science University
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Must be 50 years of age or older

• Must be currently treated with an anti-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-TNF medications is acceptable

• Diagnosis of RA or another inflammatory arthritis (Phase Ia); or RA, another inflammatory arthritis, or other inflammatory condition (e.g. psoriasis) requiring use of anti-TNF therapy (Phase Ib and II)

• Phase I subjects must test positive for VZV 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 US.

• 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 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 VZV 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 Ia patients)

• Any known contraindication to Zostavax® vaccine, including allergy or sensitivity to gelatin or any other vaccine component

• Known HIV/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.