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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2017
• Main ID: NCT02538757
• Date of registration: 18/08/2015
• Prospective Registration: No
• Primary sponsor: University of Alabama at Birmingham
• Public title: Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE) VERVE
• Scientific title: Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)
• Date of first enrolment: October 2013
• Target sample size: 125
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02538757
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jeffrey R Curtis, MD, MS, MPH
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion 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). 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 (q2 weeks) dose within 16 days (2
weeks + 2 days); Certolizumab subcutaneous (q4 weeks) dose within 32 days (4 weeks + 4
days); Golimumab subcutaneous (q4 weeks) dose within 32 days (4 weeks + 4 days);
Golimumab IV (q8 weeks) dose within 64 days (9 weeks + 1 day); Infliximab IV (q8
weeks) dose within last 64 days (9 weeks + 1 day); (Date of previous dose of
medication is required)

- 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Enteropathic Arthritis

Psoriasis

Inflammatory Arthritis

Psoriatic Arthritis

Rheumatoid Arthritis

Crohn's Disease

Ankylosing Spondylitis

Arthritis

Intervention(s)

Drug: Placebo

Biological: Herpes Zoster Vaccine

Primary Outcome(s)

Immunogenicity measured at 6 weeks [Time Frame: 6 weeks post vaccination]

Secondary Outcome(s)

The clinical effectiveness of the HZ vaccine in reducing longer-term HZ risk [Time Frame: 2 years post vaccination]

Vaccine safety of all serious adverse events (SAEs) AND non-serious vaccine-strain VZV events within 42 days of vaccination [Time Frame: 42 days post vaccination]

Secondary ID(s)

VERVE-Pilot

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oregon Health and Science University