Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators

Humoral response will be assessed by ELISA quantification of anti-glycoprotein E antibodies. Seroconversion will be defined as a fourfold or greater increase from baseline or a fourfold increase above the lower limit of quantification for participants who are seronegative at baseline. The outcome is the proportion of participants who achieve seroconversion at Day 84.

Anti-glycoprotein E antibody concentrations will be measured in serum samples using an ELISA. Titers will be log-transformed and geometric mean titers will be calculated as the exponential of the mean of the log-transformed values. The outcome is the GMT at Day 84 and its change relative to baseline.

Antibody persistence will be evaluated by quantifying anti-glycoprotein E antibody concentrations using ELISA. Results will be expressed as geometric mean titers obtained from log-transformed antibody levels. Seroconversion at one year will be defined as a fourfold or greater increase relative to baseline or a fourfold increase above the assay lower limit of quantification for participants seronegative at baseline.

Safety will be assessed by recording local and systemic adverse events through standardized diaries completed after each dose and confirmed during clinic visits. Events will be graded according to World Health Organization severity and CDC criteria.

A suspected case of herpes zoster will be defined as (1) a new unilateral, dermatomal, rash with pain (broadly defined to include allodynia, pruritus, or other abnormal sensations) without any alternative diagnosis or (2A) or a vesicular rash suggestive of varicella zoster virus infection regardless of the distribution, and no alternative diagnosis; without any alternative diagnosis. For each suspected case, the rash will be photographed and samples will be collected from three lesions to confirm the diagnosis of HZ by real-time polymerase-chain reaction (PCR) assay. If the PCR results were indeterminate or if samples were not available, the final diagnosis will be determined by unanimous agreement among the five members of an ascertainment committee, which includes a dermatologist.

Rheumatoid Arthritis (RA): An absolute increase in Disease Activity Score C-reactive protein (DAS28-CRP) > 1.2, or an increase > 0.6 if baseline > 3.2.

Score: 0 to 10 - higher values indicates higher disease activity.

Systemic Lupus Erythematosus (SLE): An increase of more than three points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).

Score: 0 - No activity; 1 - 4 mild activity; > 6 high activity

Ankylosing Spondylitis (AS): An increase in Ankylosing Spondylitis Disease Activity Score (ASDAS).

Scores activity:

<1.3: Inactive disease 1.3 to <2.1: Moderate disease activity 2.1 to 3.5: High disease activity >3.5: Very high disease activity

We will use the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).

This score ranges from 0 (minimum) to 123 (maximum). Higher scores indicates greater disease activity.