2/26/2026
According to a recent clinical trial, the recombinant shingles vaccine did not increase short-term disease flares in people with immune-mediated rheumatic diseases who are taking immunosuppressive medications. The study also demonstrated an acceptable safety profile for the vaccine.
People living with ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, lupus, and other immune-mediated rheumatic diseases are at higher risk for shingles, largely because of the medications used to suppress the immune system. Although the recombinant (non-live) shingles vaccine is recommended for immunocompromised individuals, many patients and clinicians worry that vaccination could trigger a disease flare. This study was designed to directly test that concern.
The trial was conducted at an advanced care center in Brazil. It included 1,192 adults with rheumatic diseases, all of whom were on stable immunosuppressive therapy. Participants were randomly assigned to receive either two doses of the recombinant shingles vaccine or placebo, given six weeks apart. An additional 393 healthy controls also received the vaccine to compare safety outcomes. The main outcome researchers measured was the rate of disease flares within 84 days (about three months) after the first dose.
Flare rates were very similar between groups. Fourteen percent of vaccinated patients (80 of 559) experienced a flare, compared with 15% of those who received placebo (84 of 557). In other words, the vaccine did not increase flare risk compared with placebo.
In patients with axial spondyloarthritis or psoriatic arthritis in particular, the recombinant zoster vaccine did not increase disease activity, with flare rates remaining very low (around 1–2%). The vaccine also triggered a strong protective immune response, with most participants showing a substantial rise in antibodies against the shingles virus six weeks after the second dose, even while on immunosuppressive medications.
Side effects such as injection-site reactions or fatigue were common but generally mild. Adverse events were reported less frequently in patients with rheumatic disease than in healthy controls. Serious adverse events were rare (about 1–2%) and occurred at similar rates across groups.
The researchers point out some limitations of the study. Research was conducted at a single center, and flare outcomes were assessed only over about three months, so longer-term effects were not evaluated.
Overall, the findings provide reassuring evidence that the recombinant shingles vaccine does not increase short-term flare risk in people with rheumatic diseases who are on immunosuppressive therapy. For patients at elevated risk of shingles, the study supports vaccination as a generally safe preventive option, though the researchers note that patients should still talk to doctors to discuss timing of the vaccine.
The Spondylitis Association of America recommends that individuals speak with their healthcare provider about vaccines based on their specific health situation. This research news summary is for informational purposes only and is not medical advice.
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