medwireNews: Findings from the VERVE trial suggest that the live attenuated zoster vaccine (ZVL) has favorable short-term immunogenicity and safety profiles in people with immune-mediated diseases treated with tumor necrosis factor (TNF) inhibitors.
Jeffrey Curtis (The University of Alabama at Birmingham, USA) and co-investigators explain that organizations such as the American College of Rheumatology and EULAR “recommend avoidance of live virus vaccines in patients receiving biologics” due to “a theoretical risk for primary infection in immunocompromised patients,” but no prospective studies to date have evaluated ZVL in people on TNF inhibitors.
For the phase 2 trial, 617 individuals aged 50 years or older with immune-mediated diseases – most frequently rheumatoid arthritis (57.6%), Crohn’s disease (38.5%), and psoriatic arthritis (24.1%) – treated with TNF inhibitors were randomly assigned to receive ZVL or placebo. The most commonly used TNF inhibitor was adalimumab (32.7%), followed by infliximab (31.3%) and etanercept (21.2%); almost half of the participants were on concomitant methotrexate, while 10.5% were taking glucocorticoids.
Curtis and team report in the Annals of Internal Medicine that participants given the vaccine had a significant 1.3-fold greater increase in average varicella zoster virus-specific immunoglobulin (Ig)G titers from baseline to week 6 than those given placebo, as well as a numerically greater increase in interferon-γ levels.
At the 1-year follow-up, 58.8% of participants given the vaccine still had elevated IgG levels (≥20% from baseline), whereas interferon-γ had returned to baseline levels in 75.0%.
“Although vaccine-induced IgG responses were robust, we found cell-mediated responses to be more variable and not sustained at 1 year after vaccination,” summarize the researchers.
In the safety analysis, 3.2% of participants in the ZVL arm and 2.6% of those in the placebo group experienced serious adverse events, giving a between-group difference of 0.6 percentage points that was below the noninferiority margin of 1.25 percentage points. There were no active cases of varicella zoster infection in either group.
These findings “suggest that ZVL was safe and had reasonable short-term effectiveness (based on the 6-week immunogenicity results) in participants receiving TNF [inhibitors],” say Curtis and team. They note, however, that the results may not be generalizable to younger people and those taking other classes of immunomodulatory agents such as Janus kinase inhibitors.
The team concludes: “Although country-specific labeling requirements may continue to discourage use of a live virus vaccine in immunosuppressed patients receiving biologic therapies, use of this ZVL in TNF [inhibitor]-treated patients may be a reasonable option, especially in the absence of an alternative zoster vaccine.”
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