Background/Purpose:

The live herpes zoster vaccine (ZV) has been shown to be safe and effective in large randomized controlled trials of older adults. It is currently contraindicated in participants receiving immunomodulatory therapies such as biologic agents due to theoretical concerns regarding safety.

Methods:

VERVE is a 2-site, pilot study (n=125 participants) preparatory to a large NIH-funded pragmatic randomized controlled trial (RCT) of 1,000 participants receiving anti-TNF therapy. Participants must be age >= 50 years, receiving any FDA-approved anti-TNF therapy for rheumatoid arthritis (RA), psoriatic arthritis (PsA) or other spondyloarthritis. Participants were randomized to ZV or blinded placebo. The primary outcome was immunogenicity at 6 weeks; secondary outcomes included clinical safety, tolerability, and long-term clinical effectiveness. For the pilot study, participants must also not have received glucocorticoid therapy within the past month. Results of this ongoing trial have not yet been unblinded. Therefore only baseline characteristics at the time of this abstract were available, presented as mean(SD) or %, as applicable.

Results: 

A total of 95 participants have been screened for VERVE as of June 2015. Of these, 19 have been randomized (20.0%); 3(3.2%) tested negative on screening varicella ELISA testing and were considered screen failures; 73 (76.8%) have been enrolled and are awaiting randomization. Characteristics of the 19 randomized participants included age 60(7) years, 68.4% women, 73.7% with RA, 15.8% PsA. The most commonly used concomitant DMARD therapies were methotrexate (85.7%) and hydroxychloroquine (7.1%). Concomitant biologics included adalimumab (47.1%), etanercept (23.5%), Infliximab (17.6%), and golimumab (11.8%).  The majority of participants had moderate disease activity (42.1%), with mean CDAI of 13.7(10.6). Among the 19 randomized who received ZV or placebo, there were no clinically significant serious adverse events attributable to the vaccine in the 40(16) days of follow-up (5.7 weeks; range 2.3, 9.0). 

Conclusion:

Preliminary results from VERVE have shown no immediate safety-related issues when given to patients with autoimmune diseases being actively treated with anti-TNF biologic agents. Ongoing results for the entirety of the pilot study are expected by Nov. 2015 to further characterize the immunogenicity and effectiveness of the vaccine in abti-TNF users.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-clinical-and-immunologic-effectiveness-of-the-live-zoster-vaccine-administered-to-patients-receiving-anti-tnf-biologics/