Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases

RZV comprise 50 μg of recombinant VZV glycoprotein E and the liposome-based AS01B adjuvant system (which contains 50 μg of 3-O-desacyl-4'-monophosphoryl lipid A \[MPL\] and 50 μg of Quillaja saponaria Molina, fraction 21 (QS21, licensed by GSK from Antigenics, a subsidiary of Agenus)). Vaccine will be administered (0.5 ml) into the deltoid muscle at inclusion and 6 weeks (two doses).

Evaluation of discontinuation of the use of methotrexate (MTX) for 2 weeks after each vaccine dose in ARD patients: patients using MTX at a stable dose for at least 12 weeks, prednisone maximum dose of 5 mg/day, in association or not with other drugs except rituximab will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MTX for 2 weeks after each vaccine dose (MTX-withhold) and other that will maintain stable therapy (MTX-maintain).

Evaluation of discontinuation of the use of mycophenolate mofetil (MMF) for one week after each vaccine dose in ARD patients: patients using MMF at a stable dose for at least 12 weeks, prednisone maximum dose of 7.5 mg/day, not associated with other immunosuppressive therapy, will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MMF for 2 weeks after each vaccine dose (MMF-withhold) and other that will maintain stable therapy (MMF-maintain).

Patients with ARDs who received the placebo at study entry (P2). ARD patients will be randomly assigned in a 1:1 ratio, with the use of an automated Web and telephone system, to one of two subgroups: P1, patients allocated to receive vaccine right after randomization (at D0 and D42), and P2, patients allocated to receive placebo at D0 and D42. Subsequently, blindness will be broken at D84 and P2 patients will receive vaccine doses at the D84 and D126.

MTX dose will be held stable after the two vaccine doses for comparison of vaccine immunogenicity and disease activity with the MTX-withhold group.

MMF dose will be held stable after the two vaccine doses for comparison of vaccine immunogenicity and disease activity with the MMF-withhold group.