Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER)

NCT03886038 | Completed Phase 4

• 1 other identifier: VACCIMIL-ZOSTER
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Background. A new subunit vaccine against herpes zoster (HZ) has recently been approved for vaccination of adults i in Sweden. This vaccine (Shingrix) elicits a strong cellular and humoral immune response in healthy adults regardless of age. Studies on the immunogenicity and efficacy of this vaccine in immunosuppressed patients, such as patients with rheumatoid arthritis (RA), are scarce. Objectives. To investigate: 1) the immunogenicity of subunit vaccine against HZ in patients with RA treated with janus kinase (JAK)-inhibitors compared to healthy controls; 2) the tolerability of subunit vaccine against HZ 3) long-term immunogenicity of two doses of subunit HZ vaccine 4) the impact of smoking habits and alcohol consumption on the immunogenicity of vaccine and protection against HZ 5) the efficacy of this vaccine. Methodology. Patients with RA, regularly followed at the Skåne University Hospital, section for rheumatology in southern Sweden are eligible for the study and will be offered vaccination. Blood samples will be collected immediately before the first vaccine dose and 4-6 weeks after the second dose and thereafter 3 and 5 years after the second vaccination. The levels of antibodies to glycoprotein E (gE) will be measured with standard ELISA on the blood samples collected at vaccination, 4-6 weeks following the second vaccination and after 3 and 5 years. A flow-cytometric assay will be used for the detection of the cell-mediated immunity (number of antigen specific CD4+ T-cells) against the varicella-zoster virus. The prevalence of HZ among patients participating in the study will be compared to in-patient and out-patient registry data on the corresponding infections among age- and sex- matched non-vaccinated controls using data from the regional health and care registry in southern Sweden.

Conditions

Rheumatoid Arthritis; Healthy Controls

Outcome Measures

Primary Outcomes (2)

• the differences in serological response between the groups

  levels of antibodies to glycoprotein E (gE)

  4-6 week after two vaccine doses

• the differences in the T cells response between the groups

  number of antigen specific CD4+ T-cells in blood samples collected at vaccination and after the second vaccine dose

  4-6 week after two vaccine doses

Secondary Outcomes (1)

• the differences in antibody levels to glycoprotein E between the groups 3 and 5 after vaccination

  up to 5 years after vaccination

Other Outcomes (1)

• the number of HZ infections registerd among patricipants in the study compared to non-vaccinated controls

  up to 5 years after vaccination

Study Arms (2)

RA patients on JAK inhibitors

ACTIVE COMPARATOR

RA patients treated with JAK inhibitors as a monotherapy or in combination with methotrexate/other DMARDs/prednisone for at least 3 months will receive two doses of Shingrix vaccine administrated with at least 2 months apart

Biological: Shingrix

healthy controls

ACTIVE COMPARATOR

healthy individuals without any rheumatic disease or not treated with any immunosupressive drug for any other condition will receive two doses of Shingrix vaccine administrated with at least 2 months apart

Biological: Shingrix

Interventions

Shingrix BIOLOGICAL

immunization with 2 doses of a subunit vaccine against herpes-zoster (Shingrix) administrated with at least 2 months apart

RA patients on JAK inhibitors; healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>18 years RA diagnosis RA patients treated with JAK-inhibitors as monotherapy or in combination with MTX and/or other DMARDs/prednisolone for at least 3 months (group1) regulary follow up at the rheumatology departmenet

You may not qualify if:

• pregnancy
• breastfeeding
• allergi against some of compnents in the vaccine
• ongoing infection

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University hospital, Dept of rheumatology

Lund, SE-22185, Sweden

Location

Related Publications (2)

• Kallmark H, Gullstrand B, Kahn F, Grenmyr E, Kahn R, Einarsson JT, Bengtsson AA, Kapetanovic MC. Impaired cellular immune responses to herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf626. doi: 10.1093/rheumatology/keaf626.

  PMID: 41330694 DERIVED

• Kallmark H, Bergstrom T, Nagel J, Gullstrand B, Einarsson JT, Bengtsson AA, Kapetanovic MC. Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2024 Jul 1;63(7):2024-2033. doi: 10.1093/rheumatology/kead552.

  PMID: 37851412 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: March 22, 2019
• Study Start: March 15, 2019
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

SE (1)