Session Type: ACR Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: There has been minimal evaluation of the safety of live virus vaccines in patients receiving biologic therapies who may be immunocompromised. The Varicella Zoster Vaccine (VERVE) study is a blinded, 1:1 randomized placebo-controlled trial of the live attenuated zoster vaccine (ZV) in patients receiving TNF inhibitors (TNFi) to evaluate safety and immunogenicity.
Methods: Eligible participants: at least 50 years of age, current users of TNFi for any indication, and no prior ZV. Safety follow-up occurred over 6 weeks (the FDA-specified risk window for vaccine-related infection, were it to occur). Suspected cases of varicella infection or shingles had clinical assessment, PCR collection (with subtyping to differentiate wild-type vs. vaccine [Oka]-related infection), and digital photographs. Review was conducted under oversight of an NIH-appointed Data Safety Monitoring Board. Serum and PBMCs were collected at baseline and week 6 to assess ZV-related immunity, with safety follow-up through 6 months, at which time participants were unmasked to treatment arm.
Results: Recruitment closed in December 2018, with 617 randomized participants recruited at 33 centers: mean (SD) age 62.4 (7.5) years, 66.9% female, 87.2% white, 8.8% AA, 4.4% Hispanic. Most common TNFi indications: rheumatoid arthritis (59.6%), psoriatic arthritis (24.5%); TNFi medication at baseline: adalimumab (32.7%), infliximab (31.3%), etanercept (21.2%), golimumab (9.1%), certolizumab (5.7%). Concomitant therapies included background methotrexate (48.0%), and oral glucocorticoids (10.5%). Through week 6, there were zero cases of confirmed disseminated or local varicella infection, either wild type or vaccine strain, yielding an upper bound of the 95% confidence interval for vaccine-related varicella infection of < 1%. A total of 8 rashes were swabbed for varicella PCR; none were positive, and no clinically adjudicated varicella or shingles reactivation cases were observed through week 6. VERVE will close to blinded follow up in Summer 2019 and immunologic effectiveness of ZV will be reported in the full cohort in November 2019.
Conclusion: The randomized VERVE trial comprised of more than 600 patients receiving TNFi for multiple indications observed no cases of vaccine-related varicella infection or reactivation in the 6-week risk period following live zoster vaccination. This trial informs safety concerns of use of live virus vaccines in this population.
To cite this abstract in AMA style:Curtis J, Bridges S, Cofield S, Bassler J, Ford T, Lindsey S, Kivitz A, Messaoudi I, Michaud K, Huffstutter J, Mikuls T, Ridley D, Shergy W, Siegel S, Winthrop K. Results from a Randomized Controlled Trial of the Safety of the Live Varicella Vaccine in TNF-Treated Patients [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/results-from-a-randomized-controlled-trial-of-the-safety-of-the-live-varicella-vaccine-in-tnf-treated-patients/. Accessed April 12, 2021.
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