# Immunogenicity of recombinant zoster vaccine in Rheumatoid arthritis patients

> **NIH VA I01** · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · 2024 · —

## Abstract

Rheumatoid arthritis (RA) is the most common inflammatory arthritis with a prevalence of around 0.6%
in the general population and is a common chronic autoimmune disease in the veteran population. RA patients
suffer greater mortality and morbidity from infectious diseases. This increased burden is in part related to the
immune derangements of RA itself, and some of it is attributable to the immunosuppressive therapies that are
used to treat RA.
 Herpes Zoster (HZ) reactivation is the most common opportunistic infection of treated RA patients and
is about double that of the general population. HZ already has a lifetime risk of 20-30% in the general
population. Until the recent approval of a recombinant zoster vaccine (RZV, brand name Shingrix) there was
only the live attenuated vaccine, Zostavax. It was infrequently used in RA patients on treatment due to its
contraindication in immunosuppressed individuals as it is a live virus vaccine. RZV being a subunit vaccine
does not have this limitation. In addition, RZV has been found in the general adult population to be highly
efficacious (>90%) even in persons over age 80. This has resulted in a significant potential opportunity to
protect RA patients even on immunosuppressive therapy.
 Immune protection from HZ is much different than immunity to primary varicella zoster (VZV) infection
(chickenpox) which is primarily antibody-mediated. Work from an innovative primate model of HZ suggests
that cell-mediated immunity (CMI), specifically by CD4+ T cells, is a key for protection. All of the vaccines
previously studied in RA patients have been ones that elicit protection through antibody-mediated mechanisms
and not CMI. The effect of disease-modifying antirheumatic drugs (DMARDs) on vaccine immunogenicity or
efficacy, in particular focused on RZV elicitation of CMI is not known. The proposed study is therefore
innovative, in that they propose to determine the effect of RA and DMARD treatment on the immunogenicity of
RZV. Analysis of response to RZV in RA patients proposed in this study has direct clinical relevance and
translational potential. It may influence the choices of DMARDs to be utilized as there are many options for
treating RA. It could provide data that supports a clinical trial using drug windowing where the treatment with
DMARD is withheld transiently after vaccination to improve the response.
 They hypothesize that RZV will have a reduced immunogenicity in RA patients compared to
non-RA controls and that RA patients on anti-metabolite synthetic DMARDs will have reduced
immunogenicity more than those on biologic DMARDs such as TNFi.
 They will perform a laboratory blinded observational study of 100 RA patients, the overwhelming
majority of whom are on DMARDs, and 100 age-matched non-rheumatology subjects to determine the
difference in immunogenicity of RZV between these populations.
Specific Aims: Aim 1. To determine the magnitude and differential effects of synthetic and biologic
DMARD thera...

## Key facts

- **NIH application ID:** 10929980
- **Project number:** 5I01CX002060-04
- **Recipient organization:** LOUIS STOKES CLEVELAND VA MEDICAL CENTER
- **Principal Investigator:** DAVID H CANADAY
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2021-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10929980

## Citation

> US National Institutes of Health, RePORTER application 10929980, Immunogenicity of recombinant zoster vaccine in Rheumatoid arthritis patients (5I01CX002060-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10929980. Licensed CC0.

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