Clinical trial · Interventional
Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)
Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)
NCT02538341CI-TRIAL-00055180completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ankylosing Spondylitis | — | UNRESOLVED | — |
| Arthritis | — | UNRESOLVED | — |
| Crohn's Disease | — | UNRESOLVED | — |
| Enteropathic Arthritis | — | UNRESOLVED | — |
| Inflammatory Arthritis | — | UNRESOLVED | — |
| Psoriasis | — | UNRESOLVED | — |
| Psoriatic Arthritis | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herpes Zoster (HZ) Vaccine | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Zostavax (Zoster Vaccine Live)
- description
- Zostavax (zoster vaccine live) is used to prevent herpes zoster (HZ) virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active herpes zoster (HZ) vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
- interventionNames
- Biological: Herpes Zoster (HZ) Vaccine
- type
- PLACEBO_COMPARATOR
- label
- Placebo Normal Saline
- description
- Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCurtis JR, Cofield SS, Bridges SL Jr, Bassler J, Deodhar A, Ford TL, Huffstutter J, Jankeel A, Kivitz A, Kamal S, Lindsey S, Messaoudi I, Mendoza N, Michaud K, Mikuls TR, Ridley D, Shergy W, Siegel SAR, Winthrop KL. The Safety and Immunologic Effectiveness of the Live Varicella-Zoster Vaccine in Patients Receiving Tumor Necrosis Factor Inhibitor Therapy : A Randomized Controlled Trial. Ann Intern Med. 2021 Nov;174(11):1510-1518. doi: 10.7326/M20-6928. Epub 2021 Sep 28. PMID 34570596