Shingles Vaccination Found Safe For Seniors With Inflammatory Conditions

According to a new clinical study led by researchers from the University of Alabama at Birmingham, the live zoster virus vaccine (Zostavax) was found to be safe for people who are currently receiving tumor necrosis factor inhibitor (TNFi) biologic therapies for various indications.

The randomized VERVE clinical trial comprised 617 patients receiving TNFi for multiple indications, observed no cases of vaccine-related varicella infection or reactivation, in the 6-week risk period following live zoster vaccination.

The VERVE participants' TNFi indications included 59 percent with rheumatoid arthritis (RA) and 24.5 percent with psoriatic arthritis (PsA).

This is good news for seniors with rheumatic conditions desiring to be protected from a Shingles outbreak or postherpetic neuralgia (PHN), the most common complication of herpes zoster. 

Herpes zoster is caused by the reactivation of the varicella-zoster virus, the same virus that causes varicella (chickenpox), says the Centers for Disease Control and Prevention (CDC).

A person’s risk of having PHN after herpes zoster increases with age. Approximately 10 to 13 percent of people 60 years and older with herpes zoster will get PHN.

Moreover, the CDC says people with compromised or suppressed immune systems are more likely to have complications from herpes zoster.

These researchers found ‘in healthy individuals, excess TNF in the blood is modulated naturally, but in those who have rheumatic conditions, higher levels of TNF in the blood and joints lead to more inflammation and persistent symptoms.’

And, ‘medications that block TNF can alter a disease's effect on the body by controlling inflammation in the joints, gastrointestinal tract, and skin.’

"Shingles manifests in most patients as a painful blistering rash that lasts a few weeks, but serious complications such as disseminated disease, eye involvement, and even strokes can occur," said Jeffrey R. Curtis, M.D., MS, MPH, a professor of medicine at the University of Alabama at Birmingham's Division of Clinical Immunology and Rheumatology, and the study's lead author. 

"While the need for prevention in patients with rheumatic diseases is compelling, the use of any weakened (attenuated) live virus vaccine is potentially a safety risk. There is a theoretical risk that a live virus vaccine could give a patient the weakened form of infection.” 

“A major goal of the trial was to understand the safety of this live virus vaccine and to see if it caused infection in any of the participants,” said Dr. Curtis, in a press release.

Through the 6th week, these researchers observed 0 cases of confirmed disseminated or local varicella infection of either wild-type or vaccine strain. 

This result yielded an upper bound of the 95 percent confidence interval for a vaccine-related varicella infection rate of approximately 1 percent. Eight patients that did develop a rash were tested for varicella by PCR, but none were positive for infection.

The researchers closed the VERVE trial in Summer 2019 to a blinded follow-up and will report the immunologic effectiveness of ZV in the full cohort at the ACR/ARP Annual Meeting on November 10, 2019, in Abstract #824. 

"The clinical significance of the trial is to provide high-quality direct evidence of the safety of this live virus vaccine in patients who previously were warned not to use it because of the theoretical risk for it to cause infection," said Dr. Curtis. 

"It also opens the door for the idea that for TNFi users, perhaps other live virus vaccines, also may be safe and might be considered in certain circumstances.” 

“A trial of this new shingles vaccine (Shingrix) is being planned for these patients and likely will begin in 2020, Dr. Curtis concluded.

TNF inhibitors are a group of medications used worldwide to treat inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, juvenile arthritis, inflammatory bowel disease (Crohn’s and ulcerative colitis), ankylosing spondylitis, and psoriasis. 

They reduce inflammation and can stop disease progression by targeting TNF.

There are 6 different TNF inhibitors that have been approved by the U.S. Food and Drug Administration for the treatment of rheumatic diseases. 

To decrease side effects and costs, most patients with mild or moderate disease may be treated with methotrexate before adding or switching to a TNF inhibitor. 

These agents can be used by themselves or in combination with other medications such as prednisone, methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine, reported this study.

Recent Shingles vaccine news

• September 26, 2019 – A Seattle-based biotechnology company announced encouraging preliminary Phase I study results of their Shingles vaccine candidate, CRV-101.
• August 8th, 2019 – According to Nakul Shekhawat, M.D., and his colleagues at the University of Michigan, the incidence of herpes zoster ophthalmicus —shingles of the eye—had tripled in the United States from 2004 to 2016.

According to the CDC, shingles vaccination has been available in the United States since 2006 with the approval of the Zostavax a live zoster vaccine. Since then, this vaccine has been recommended for routine use in all adults aged 60 years or older and is now approved for use in adults aged 50 years or older. 

In October 2017, the Advisory Committee on Immunization Practices (ACIP) of the CDC issued a recommendation for use of a new shingles vaccine called Shingrix a recombinant zoster vaccine.

The new UAB research was supported by the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Shingles vaccine news is published by Precision Vaccinations