Live Attenuated Shingles Vaccine Safe and Effective in SLE Patients, Trial Shows

Zostavax, a live attenuated herpes zoster vaccine, is well-tolerated and causes an antibody response in patients with systemic lupus erythematosus (SLE), who have a significant risk of herpes zoster infection and reactivation, a trial shows.

The research, “Safety and Immune Response of a Live Attenuated Herpes Zoster Vaccine in Patients with Systemic Lupus Erythematosus (SLE): A Randomized Placebo-Controlled Trial,” was presented recently at the American College of Rheumatology/Association of Rheumatology Health Professionals 2018 Annual Meeting in Chicago.

Herpes zoster, or shingles, is a viral infection caused by the chickenpox virus — called varicella zoster virus (VZV). The condition may appear even decades after a person has recovered from chickenpox, and is characterized by a painful skin rash and blisters on the body.

While anyone who had chickenpox can develop shingles, patients with a compromised immune system, and particularly those with SLE, seem to be at the highest risk.

Until recently, Zostavax was the only vaccine approved for preventing shingles, but given the use of a live attenuated virus and the lack of safety data in immunocompromised patients, the vaccine was recommended only for patients whose immune system is not seriously compromised.

A research team, led by Chi-Chiu Mok, MD, from the University of Hong Kong, conducted a randomized, placebo-controlled trial aimed at determining if Zostavax is safe and induces an immune response in SLE patients.

Their study included 90 SLE patients with mild to moderate disease activity who were randomly assigned Zostavax or a placebo, injected under the skin. To be eligible, participants were required to be on stable immunosuppressive treatment for the six months prior to the trial.

To determine the vaccine’s effects on the immune system, researchers measured the levels of antibodies against the varicella zoster virus, with higher levels reflecting a positive response to the vaccine.

At the start of the study, patients in both groups had similar lupus activity scores, white blood cell counts, antibody levels, and a similar need for immunosuppressive agents.

But while the average anti-varicella zoster antibodies increased by 59.8% from initial levels after six weeks among patients given the vaccine, they decreased by 2.1% in the placebo group.

In addition, the amount of T-cells responding to herpes zoster — measured by the production of interferon gamma — increased in patients given the vaccine, while their numbers dropped in placebo-treated patients.

Overall, there were 21 adverse events in the 45 patients given the vaccine, and six among the 45 patients assigned a placebo. However, none of the adverse events were serious.

Significantly more patients on the vaccine complained of injection site pain and skin redness (31%) than those on placebo (7%). Two additional patients on the vaccine had a mild flare of skin or joint disease, and one patient on placebo had a mild increase in urine protein levels between study start and week six.

Importantly, none of the patients had evidence of herpes zoster infection after vaccination.

“In patients with stable SLE who were not receiving intensive immunosuppression, vaccination with the live attenuated HZ [herpes zoster] vaccine provoked an expected cell-mediated and humoral response,” the researchers concluded. “The HZ vaccine was well tolerated.”