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

NCT07280741 | Recruiting Phase 4

• 1 other identifier: 94187625300000068
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional phase IV clinical trial will evaluate the efficacy, immunogenicity and safety of the adjuvanted recombinant herpes zoster vaccine (RZV) in adults with autoimmune rheumatic diseases (ARDs) receiving immunomodulatory monotherapy. Humoral immune response will be quantified by anti-glycoprotein E (anti-gE) antibody titers. Patients will receive two doses of RZV. Outcomes include seroconversion and geometric mean titers six weeks after completion of the vaccination schedule, persistence of antibody titers at one year, and incidence of confirmed herpes zoster during follow-up.

Conditions

Autoimmune Rheumatic Diseases

Keywords

Immunogenicity; Hepers Zoster; Vaccine; Safety; Immunomodulators; Inflammation

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate of anti-glycoprotein E (anti-gE) antibodies six weeks after completion of the RZV vaccination schedule

  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.

  Baseline (Day 1) through day 84.

Secondary Outcomes (8)

• Geometric mean titers of anti-glycoprotein E antibodies six weeks after completion of the RZV vaccination schedule

  Baseline (Day 1) through day 84.

• Persistence of antibody titers one year after completion of the RZV vaccination scheme

  Day 1 (baseline) through day 84 and one year after the second dose (Day 365)

• Safety of RZV vaccine in ARD patients under immunomodulators

  Baseline (Day 1) through day 84.

• Incidence of herpes zoster over one year following RZV vaccination in ARD patients under immunomodulators therapy

  Day 42 through one year after the second dose (D365).

• Disease safety (flare) - Rheumatoid Arthritis

  Day 1 (baseline) through day 42 and six weeks after the second dose D84.

Study Arms (1)

Immunomodulator Monotherapy

EXPERIMENTAL

Participants with autoimmune rheumatic diseases who are clinically stable and receiving monotherapy with hydroxychloroquine or sulfasalazine will receive two doses of the recombinant zoster vaccine (RZV, Shingrix) administered intramuscularly on Day 0 and Day 42. Immunogenicity will be evaluated through anti-glycoprotein E antibody titers at baseline, six weeks, and one year after vaccination. Safety, disease activity, and incidence of herpes zoster will be monitored throughout follow-up.

Biological: Recombinant Zoster Vaccine (RZV)

Interventions

Recombinant Zoster Vaccine (RZV) BIOLOGICAL

VRZ (Shingrix®) is composed of 50 μg of recombinant VZV glycoprotein E (gE) and the liposome-based AS01B (HZ/su) adjuvant system (containing 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). Two doses of the vaccine will be administered (0.5 mL) into the deltoid muscle on days (D) 0 and D42.

Immunomodulator Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Diagnosis of an autoimmune rheumatic disease (such as rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, psoriatic arthritis, systemic sclerosis, Sjögren syndrome, idiopathic inflammatory myopathies, or primary systemic vasculitis) according to validated classification criteria.
• Clinical stability at the time of enrollment, defined as no change in disease-modifying therapy or corticosteroid dose in the preceding four weeks and no evidence of infection or disease flare.
• Can be under prednisone use of 5mg/week.
• Ability and willingness to comply with study procedures and follow-up visits.
• Provision of written informed consent.

You may not qualify if:

• Previous vaccination with recombinant zoster vaccine (RZV).
• History of herpes zoster or varicella infection within 12 months before enrollment.
• Concomitant use of systemic immunosuppressive therapy including but not limited to methotrexate, mycophenolate mofetil, azathioprine, cyclophosphamide, biologics, or JAK inhibitors.
• Use of glucocorticoids \>5mg/week.
• Acute febrile illness or active infection at the time of vaccination.
• Pregnancy or breastfeeding.
• Known hypersensitivity to any component of the recombinant zoster vaccine.
• History of Guillain-Barré syndrome.
• Any condition that, in the investigators' judgment, could interfere with study participation or interpretation of results.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (7)

• Venerito V, Stefanizzi P, Cantarini L, Lavista M, Galeone MG, Di Lorenzo A, Iannone F, Tafuri S, Lopalco G. Immunogenicity and Safety of Adjuvanted Recombinant Zoster Vaccine in Rheumatoid Arthritis Patients on Anti-Cellular Biologic Agents or JAK Inhibitors: A Prospective Observational Study. Int J Mol Sci. 2023 Apr 9;24(8):6967. doi: 10.3390/ijms24086967.

  PMID: 37108130 BACKGROUND

• Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, Grande E, Marrupe Gonzalez D, Lowndes S, Puente J, Kristeleit H, Farrugia D, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Godeaux O, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1.

  PMID: 30707761 BACKGROUND

• Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macias G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, Lopez-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6.

  PMID: 31399377 BACKGROUND

• Qian J, Lassere MN, Heywood AE, Liu B. Use of disease-modifying antirheumatic drugs and the subsequent risk of herpes zoster in older adults. Rheumatology (Oxford). 2021 Nov 3;60(11):5042-5051. doi: 10.1093/rheumatology/keab538.

  PMID: 34508560 BACKGROUND

• Yun H, Yang S, Chen L, Xie F, Winthrop K, Baddley JW, Saag KG, Singh J, Curtis JR. Risk of Herpes Zoster in Autoimmune and Inflammatory Diseases: Implications for Vaccination. Arthritis Rheumatol. 2016 Sep;68(9):2328-37. doi: 10.1002/art.39670.

  PMID: 26990731 BACKGROUND

• Yap RXL, Lai YW, Wei C, Ng JJW, Xu D, Feng S, Mu R, Thong BY, Xu C. Impact of Immunomodulatory Therapy on COVID-19 Vaccine Response in Patients with Autoimmune Inflammatory Rheumatic Diseases. Vaccines (Basel). 2024 Mar 6;12(3):274. doi: 10.3390/vaccines12030274.

  PMID: 38543908 BACKGROUND

• van Sleen Y, van der Geest KSM, Huckriede ALW, van Baarle D, Brouwer E. Effect of DMARDs on the immunogenicity of vaccines. Nat Rev Rheumatol. 2023 Sep;19(9):560-575. doi: 10.1038/s41584-023-00992-8. Epub 2023 Jul 12.

  PMID: 37438402 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eloisa Bonfa, Full Professor

CONTACT

+55 11 3061-7492; eloisa.bonfa@hc.fm.usp.br

Clovis Silva, Full Professor

CONTACT

+55 11 3061-7492; clovisaasilva@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: March 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)