Rheumatoid Arthritis Clinical Trial
Official title:
Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)
The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the herpes zoster (shingles) vaccine, Zostavax, in arthritis patients over 50 years old who are using anti-TNF therapy and who have not previously received the vaccine. This pilot study of 125 patients will serve as a backdrop for the larger study that is currently recruiting NCT02538341.
Herpes zoster (HZ), also known as "shingles", is caused by reactivation and multiplication of
the ubiquitous varicella zoster virus (VZV) that remains latent in everyone's sensory neurons
following varicella, or "chickenpox". Among individuals who live to age 85, the lifetime risk
for HZ is 50%, and more than one in five individuals affected by zoster develop post-herpetic
neuralgia, resulting in chronic pain. Other serious complications include encephalitis,
permanent vision loss, or more rarely, dissemination and death. Fortunately, a live
attenuated vaccine is available and can reduce HZ risk by up to 70%. For patients with
rheumatoid arthritis (RA), this vaccine has great potential to provide improved quality of
life by reducing the incidence and complications associated with zoster. Due to the
underlying disease and/or treatments (e.g. steroids) for rheumatoid arthritis (RA), the risk
of herpes zoster in RA patients is approximately double in the general population. This
increased risk should make prevention of zoster and vaccination exceedingly important for RA
patients. In fact, because of a higher overall absolute risk for zoster in RA, the vaccine
yields a comparable or even greater absolute risk reduction to reduce the risk of shingles
and post-herpetic neuralgia in an RA population as it does in the general population.
However, the use of the zoster vaccine in RA patients is very low (< 5%), and less frequently
used than for the general population.
National guidelines from the Centers for Disease Control and Prevention's (CDC) Advisory
Committee on Immunization Practices (ACIP) recommend a single dose of the zoster vaccine for
all individuals age 60 or older, with the vaccine more recently gaining FDA-approval for
administration to persons age 50 and older. While a large number of RA patients would
otherwise be recommended to receive this vaccine on the basis of age, theoretical safety
concerns related to vaccination likely explain the very low vaccination rates observed.
Currently, the Federal Drug Administration (FDA), the ACIP, and the American College of
Rheumatology (ACR) consider the live zoster vaccine contraindicated in patients receiving
immunosuppressive medications, such as biologic therapies. Such contraindication stems from
the theoretical safety concern that these individuals could develop a varicella-like
infection from the vaccine virus strain. However, investigators hypothesize that this vaccine
can safely be given in this setting, as no published data is available to suggest that these
safety concerns are warranted. A growing body of observational data suggests that vaccinating
RA patients receiving biologic therapies with this vaccine may in fact be safe. Moreover, and
similarly with little or no evidence, the ACIP considers the vaccine safe and acceptable for
patients using methotrexate at doses commonly used to treat RA (e.g. <= 25 mg/week) and for
patients using glucocorticoids at prednisone-equivalent doses of ≤ 20 mg/day.
In light of 1) a substantial elevated HZ risk among RA patients; 2) national data showing
most RA patients are not vaccinated for HZ; and 3) the high effectiveness of this vaccine in
the general population, the investigators propose to conduct the Varicella zostER VaccinE
(VERVE) trial, a randomized, double-blind, placebo-controlled study to evaluate the safety,
tolerability, and long-term effectiveness of the live herpes zoster vaccine. This pilot study
will recruit the first 125 patients of the needed 1,000 individuals age 50 years or older
currently receiving anti-TNF therapy for RA or other inflammatory arthritis. Within a
relevant 6-week safety window, the investigators will collect serious adverse events
(satisfying a regulatory definition of a SAE) including non-serious events of vaccine-strain
varicella-like infection or herpes zoster. Beyond the key public health importance of the
clinical question addressed, clinical trial methodological innovations anticipated for this
unique large pragmatic trial. Additionally, the investigators will study vaccine tolerability
and long-term effectiveness through a linkage to health plan data to allow for cost-effective
follow-up while minimizing participant and study-site burden. Results from this pilot study
will facilitate the parent trial and change RA management by demonstrating the clinical
safety and immunogenicity of the live zoster vaccine among current anti-TNF users.
Rheumatologists and other providers will be able to improve the care, outcomes, and quality
of life for RA patients, substantially decreasing the morbidity of herpes zoster and its
complications over a lifetime.
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