Clinical trial NCT05879419: Recombinant Herpes Zoster Vaccine in Patients with Autoimmune Rheumatic Diseases
Official title: Efficacy, Immunogenicity and Safety of Recombinant Vaccine Against Herpes Zoster (RZV or SHINGRIX®) in Patients with Autoimmune Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Spondylitis, Ankylosing
Spondyloarthritis
Systemic Lupus Erythematosus
Sjogren's Syndrome
Systemic Sclerosis
Idiopathic Inflammatory Myopathies
Vasculitis, Systemic
Juvenile Idiopathic Arthritis
Dermatomyositis, Juvenile
Behçet Disease
Keywords: Recombinant herpes zoster vaccine
Herpes zoster
Autoimmune rheumatic diseases
Disease activity
Safety
Immunogenicity
Disease-modifying anti-rheumatic drugs
Biological disease-modifying anti-rheumatic drugs
Glucocorticoid
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-05-30
Enrollment: 2005
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subproject A: Randomized prospective study of adult patients with ARDs who will receive two intramuscular doses of RZV 6 weeks apart or placebo.

Subproject B: Specific studies will evaluate the effect of drug withdrawal (MTX and MMF) after vaccination in increasing the immune response in patients with ARDs with controlled baseline disease. Randomization of patients with ARDs with well-controlled disease selected for the MTX discontinuation protocol will divide them into two groups: MTX-suspension, in which MTX will be suspended for 2 weeks after each vaccine dose, and another group that will maintain stable therapy (MTX-maintenance), with assessments of immunogenicity and disease activity. The same applies to patients undergoing the MMF discontinuation protocol (but the MMF suspension time will be one week after each vaccine dose).
Primary purpose: PREVENTION

Brief summary: Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infection. This increased susceptibility is caused by a deficient cell-mediated immune response due to the underlying disease and glucocorticoid and immunosuppressive treatments that impair the T-cell response, including conventional and unconventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological agents. In this context, the recent availability of a recombinant vaccine against HZ (RZV or Shingrix®), composed of recombinant VZV glycoprotein E (gE) and the AS01B adjuvant system (HZ/su), is a major progress regarding safety for immunosuppressed patients. Its effectiveness, however, has been clearly demonstrated for non-immunosuppressed patients and in selected populations of immunocompromised individuals. There are no prospective controlled studies evaluating the immunogenicity of RZV and its impact on the activity of the underlying disease, as well as its safety in patients with ARDs at high-risk for HZ.

Hypothesis: RZV has a good safety profile, including with respect to underlying rheumatic disease activity, in patients with ARDs at high risk of HZ.

Objectives: Primary: To assess the short-term safety profile in relation to underlying disease activity in patients with ARDs at high risk of HZ immunized with RZV compared to unvaccinated patients. Secondary: To evaluate the general safety of the vaccine in patients with ARDs at high risk of HZ immunized with RZV and non-immunosuppressed control subjects (CG); the humoral and cellular immunogenicity of RZV in patients with ARDs at high risk of HZ compared to CG; the influence of disease treatment on vaccine response; the 12-month persistence of humoral immunogenicity and incident cases of HZ. Specific studies will also be carried out to evaluate the effect of drug withdrawal (methotrexate-MTX and mycophenolate mofetil-MMF) after vaccination in increasing the immune response in patients with ARDs with controlled underlying disease.

Detailed description: Methods:

Subproject A: This is a phase 4 randomized prospective study of adult patients with ARDs who will receive two intramuscular doses of RZV 6 weeks apart. A control group of non-immunosuppressed individuals (CG) aged ≥ 50 years will also be included, in the proportion of 3 patients:1 control. Patients with ARDs will be randomly allocated into two groups: P1 and P2. CG and P1 will receive the vaccine soon after randomization, on D0 and D42. P2 will be vaccinated 12 weeks after randomization, on D84 and D126. All groups will collect blood samples immediately before vaccination, at baseline, and then receive the 1st dose of vaccine on the same day (D0 for CG and P1, and D84 for P2). The second dose will be applied 6 weeks after the first dose (D42 for P1 and CG, and D126 for P2). Blood samples for disease activity and immunogenicity will be collected 6 weeks after the 2nd dose (D84 for CG and P1 and D168 for P2). The influence of vaccination on disease activity will be evaluated in the first three months of follow-up through disease-specific activity indices. Safety analysis regarding adverse effects (AEs) of the vaccine will be performed using standardized questionnaires on D42 and D84 for CG and P1 and on D126 and D168 for P2. Severe AEs and incident cases of HZ will be evaluated throughout the study period. The persistence of immunogenicity will be evaluated one year after the 2nd dose (D407 for CG and P1, and D491 for P2).

Subproject B: Specific studies will also be carried out to evaluate the effect of drug withdrawal (MTX and MMF) after vaccination in increasing the immune response in patients with ARDs with controlled baseline disease. Randomization of patients with ARDs with well-controlled disease selected for the MTX discontinuation protocol will divide them into two groups: MTX-suspension, in which MTX will be suspended for 2 weeks after each vaccine dose, and another group that will maintain stable therapy (MTX-maintenance), with assessments of immunogenicity and disease activity. The same applies to patients undergoing the MMF discontinuation protocol (but the MMF suspension time will be one week after each vaccine dose). Based on a recently published study (Petri et al., 2023), discontinuation time of the MMF after each vaccine dose was reduced from two weeks to one week. In fact, these authors observed in a cohort of 334 patients with systemic lupus erythematosus that discontinuing MMF for one week after vaccination against COVID-19 (mRNA vaccine) improved vaccine efficacy without leading to exacerbations of the underlying disease (Petri et al., 2023). Thus, we considered it appropriate to reduce the MMF discontinuation time to one week after each dose of the recombinant vaccine for herpes zoster in our population of patients with autoimmune rheumatic diseases.

Total population: The total population will consist of 2005 participants comprising 1180 patients with ARDs (590 in P1 and 590 in P2), 393 healthy controls. 202 patients on the MTX maintenance/discontinuation RA protocol for two weeks after each vaccine dose, and 230 patients with ARDs on the MMF maintenance/discontinuation protocol for one week after each vaccine dose.

Immunogenicity analysis: Humoral immunogenicity will be evaluated through serum concentrations of anti-gE antibodies \[enzyme-linked immunosorbent assay (ELISA)\] of blood samples collected from participants pre-vaccination, 2 months and one year after the second dose of RZV. The frequencies of gE-specific CD4\[2+\] T cells will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of the total number of participants) from patients with ARDs and healthy controls.

Eligibility criteria: Inclusion Criteria:

* All subjects will be adults (≥18 years-old).
* ARD patients will be selected from patients regularly followed up at the Outpatient Rheumatology Clinics of the Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil, according to the specific classification criteria: RA (Aletaha et al., 2010), SLE (Petri et al., 2012), pSS (Vitali et al., 2002), SSc (van den Hoogen et al., 2013), IIM (Lundberg et al., 2017), axial spondyloarthritis (axSpA) (Rudwaleit et al., 2009), PsA (Tillett et al., 2012) and granulomatosis with polyangiitis (Leavitt et al., 1990).
* Patients must be under current use of cyclophosphamide, mycophenolate mofetil, azathioprine, cyclosporin, tacrolimus, leflunomide, glucocorticoids, methotrexate, biologic therapy or JAKi with or without csDMARDs for at least one month prior to study inclusion.

Exclusion Criteria:

* history of any reaction or hypersensitivity to any component of the vaccine;
* previous HZ vaccination;
* any occurrence of Guillain-Barré syndrome;
* hospitalization, acute infectious disease or fever at the time of vaccination;
* pregnancy or lactation at the time of vaccination;
* history of HZ within the 12 months preceding the first dose of study vaccine;
* people living with HIV/AIDS (PLWHA).

Primary outcomes:
measure: Subproject A: Disease safety (flare) in ARD patients immunized with RZV in comparison to non-vaccinated ARD patients (placebo group)
timeFrame: Six months
measure: Subproject B: Effect of MTX discontinuation on immunogenicity in comparison to MTX maintenance
timeFrame: One year
measure: Subproject B: Effect of MMF discontinuation on immunogenicity in comparison to MMF maintenance
timeFrame: One year
Secondary outcomes:
measure: Subproject A: Incidence of vaccine adverse events [safety and tolerability] in ARD patients immunized with RZV in comparison to non-vaccinated ARD patients (placebo group) and non-immunosupressed controls (control group)
timeFrame: Eighteen months
measure: Subproject A: Humoral immunogenicity of the RZV in ARD patients in comparison to non-immunosupressed control group
timeFrame: One year
Other outcomes:
measure: Subproject A: Incident cases of HZ after RZV vaccination in ARD patients and in the non-immunosupressed control group
timeFrame: Eighteen months
Locations:
city: São Paulo
country: Brazil
facility: Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
state: Sao Paulo
Study officials:
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