VERVE – Clinical Trial Participation Offer

The opportunity to participate in VERVE, a large pragmatic trial comparing the commercially available zoster vaccine to placebo among patients age 50+ on TNFi therapy, has been offered to UR members by Jeff Curtis and co investigators at University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology.
Trial highlights:
· Two visits total, six weeks apart.: One visit is ‘extra’ beyond standard of care. Blood is collected and sent at each of these 2 visits.
· Vaccine is paid for by the study, and patients also are compensated $100/ea
· Max. dose prednisone 10mg/day
· Site budget limited as this is NIH funded and not pharma funded, but it will cover its costs
· Trial is done under an IND from FDA with a DSMB
· Total sample size is 1000 people. Jeff et al have 125+ people into it. They are seeking around 25 sites in total.
· As long as sites don’t have to use their own local IRB, UAB can be the IRB of record, and will do most of the regulatory work.
Basically, everyone age 50+ who hasn’t gotten zostavax and is on a TNF will qualify, which is where the compensation is most efficient because the modest per-patient budget can be made up on volume. Big sites could probably enroll 50+ patients, and there is no cap.
For more information please visit: https://clinicaltrials.gov/ct2/show/study/NCT02538341 or contact Jeff Curtis , jrcurtis@uabmc.edu, or Anita Turner, anitaturner@uabmc.edu, at University of Alamaba at Birmingham directly.

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