Trial Evaluates Safety Concerns With Live Attenuated Zoster Vaccine in Patients Receiving Tumor Necrosis Factor Inhibitor Therapy
The objective of this study was to evaluate the safety and immunogenicity of the live attenuated zoster vaccine (ZVL) in patients receiving TNFis, according to the study authors.
A recent trial published in the Annals of Internal Medicine evaluated safety concerns that have arisen with the use of live virus vaccines, including varicella-zoster vaccines (VZV), in patients receiving tumor necrosis factor inhibitors (TNFis).
It has been unknown how safe and effective live virus vaccines are in patients with inflammatory diseases who are receiving immunomodulatory therapy, such as VZV, and in treatments such as TNFis. The objective of this study was to evaluate the safety and immunogenicity of the live attenuated zoster vaccine (ZVL) in patients receiving TNFis, according to the study authors.
A randomized, blinded, placebo-controlled trial involved adults 50 years of age and older receiving TNFis for any indication who were randomly assigned to ZVL versus placebo. The researchers measured glycoprotein enzyme-linked immunosorbent assay (gpELISA) and enzyme-linked immunosorbent spot (ELISpot) from serum and peripheral blood mononuclear cells at baseline and 6 weeks after vaccination. Further, suspected varicella infection or herpes zoster was clinically assessed using digital photographs and polymerase chain reaction on vesicular fluid.
The trial randomly assigned 617 participants to ZVL or placebo between March 2015 and December 2018 at 33 centers, with the most common TNFi indications being rheumatoid arthritis and psoriatic arthritis with medications adalimumab, infliximab, etanercept, golimumab, and certolizumab. Concomitant therapies were methotrexate and oral glucocorticoids, according to the study authors.
There were no cases of confirmed varicella infection found through week 6 or any cumulative incidence of varicella infection or shingles. Compared with the baseline, the mean increases in geometric mean fold rise as measured by gpELISA and ELISpot were 1.33% percentage points and 1.39% percentage points, respectively.
The limitations that were analyzed that need further attention were the potentially linked generalizability to patients receiving other types of immunomodulators, according to the study authors.
The study authors concluded that the trial informs safety concerns regarding the use of live virus vaccines among patients on biologic therapy.
Bridges LS, Cofield SS, Curtis JR, et al. The safety and immunologic effectiveness of the live varicella-zoster vaccine in patients receiving tumor necrosis factor inhibitor therapy. Annals of Internal Medicine. September 28, 2021. https://doi.org/10.7326/M20-6928