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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538341
Recruitment Status : Completed
First Posted : September 2, 2015
Results First Posted : November 23, 2021
Last Update Posted : November 23, 2021
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Jeff Curtis, MD, University of Alabama at Birmingham

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Inflammatory Arthritis Arthritis Psoriatic Arthritis Psoriasis Ankylosing Spondylitis Enteropathic Arthritis Crohn's Disease Biological: Herpes Zoster (HZ) Vaccine Drug: Placebo Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles Vaccines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Zostavax (Zoster Vaccine Live)
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.
 Biological: Herpes Zoster (HZ) Vaccine
Other Name: Zostavax
Placebo Comparator: Placebo Normal Saline
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
 Drug: Placebo
Other Name: Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 6 Weeks [ Time Frame: 6 weeks post vaccination ]
    Study protocol defined measure for immunogenicity samples.

  2. GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 6 Weeks [ Time Frame: 6 weeks post vaccination ]
    Study protocol defined measure for immunogenicity samples.


Secondary Outcome Measures :
  1. GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 1 Year [ Time Frame: Baseline to 1 year ]
    Study defined measure from labs. GMFR (Geometric Mean Fold Rise ) in varicella zoster virus (VZV) glycoprotein enzyme-linked immunosorbent assay (gpELISA) immunoglobulin G (IgG) levels

  2. GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 1 Year [ Time Frame: Baseline to 1 year ]
    Study defined measures from labs. GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) enzyme-linked immune absorbent spot (ELISpot) interferon gamma (IFNg)

  3. Number of Samples With Confirmed Varicella [ Time Frame: "Placebo Normal Saline Arm/Group was assessed up to 6 months and the "Zoster Vaccine Live (Zostavax)" Arm/Group was assessed up to 1 year ]
    Evaluated all serious adverse events (SAEs) AND non-serious varicella zoster virus (VZV) events

  4. Vaccine Tolerability Within 42 Days Following Vaccination. [ Time Frame: 42 days post vaccination ]
    Patient self report data in the form of a diary to include injection site reactions; symptoms of swelling, redness or tenderness. Diary was completed from study injection administration up to 6 week visit

  5. Evaluate Rheumatoid Arthritis Disease Activity Using the Clinical Disease Activity Index (CDAI) [ Time Frame: 42 days post vaccination ]
    Rheumatoid arthritis disease activity will be measured using the clinical disease activity index (CDAI). Clinical disease activity index (CDAI) is a measure of rheumatoid arthritis disease activity and is scored on a scale ranging from 0-76, with lower numbers indicated better control of disease. Values <=10 are consistent with low disease activity or remission.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538341


Locations
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Sponsors and Collaborators
University of Alabama at Birmingham
Oregon Health and Science University
Investigators
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Principal Investigator: Jeffrey R Curtis, MD, MS, MPH University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Jeff Curtis, MD, University of Alabama at Birmingham:
Study Protocol and Statistical Analysis Plan  [PDF] August 8, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeff Curtis, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02538341    
Obsolete Identifiers: NCT01967316, NCT02538757
Other Study ID Numbers: VERVE-UM1
First Posted: September 2, 2015    Key Record Dates
Results First Posted: November 23, 2021
Last Update Posted: November 23, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Crohn Disease
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Bone Diseases, Infectious
Infections
Ankylosis