2024-518190-34-00RecruitingPhase 4
Characterization of the immune response in immunosuppressed patients with rheumatic diseases, including to the recombinant zoster vaccine
Centre Hospitalier Universitaire De Toulouse2 sites in 1 country60 target enrollmentStarted: May 28, 2025Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Geometric mean titer (GMT) of gE-specific IgG measured by ELISA at day 90
Study Overview
Brief Summary
to assess the immunogenicity of the RZV vaccine (gE-specific antibody and T cell responses) in RD patients treated with JAKi (monotherapy or combined with Methotrexate) or with Methotrexate only one month after the second vaccine dose (day 90 after dose 1)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with rheumatic diseases currently with JAK-inhibitors (monotherapy or combined with Methotrexate) or with Methotrexate only and scheduled to receive the RZV vaccine
- •In stable clinical condition, as determined by the recruiting investigators
- •≥ 18 years of age
- •Able and willing to provide informed consent
Exclusion Criteria
- •Ongoing signs of febrile or non-febrile infection
- •Patient under legal protection (only for France)
- •Recent pregnancy with delivery in the six months preceding vaccination and/or planned pregnancy in the six months following RZV vaccination
- •Immunosuppression from the following: HIV infection; Current malignant neoplasm; primary immunodeficiency; recent (<2 years) solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy; conditions requiring medication with immunosuppressive drugs (including steroids > 5 mg/day))
- •Having received a vaccine in the last month or is expected to receive a vaccine in the next month
- •Presented with herpes zoster in the previous year
- •Hypersensitivity to the active substance or to one of the excipients
- •Pregnancy or breastfeeding (only for France)
- •Woman of childbearing age and without effective contraception throughout the duration of the study (only for France)
- •Non-affiliation to the French Social Security System. (only for France)
Outcomes
Primary Outcomes
Geometric mean titer (GMT) of gE-specific IgG measured by ELISA at day 90
Geometric mean titer (GMT) of gE-specific IgG measured by ELISA at day 90
Mean of gE-specific CD4+ T cells expressing at least 2 markers (CD40L, IFN-gamma, IL-2, TNF-alpha) measured at day 90 per millions of T cells, measured by flow cytometry at day 90
Mean of gE-specific CD4+ T cells expressing at least 2 markers (CD40L, IFN-gamma, IL-2, TNF-alpha) measured at day 90 per millions of T cells, measured by flow cytometry at day 90
Secondary Outcomes
- Frequency of self-reported clinical symptoms occurring 7 days after each vaccination
- Increase in pro-inflammatory markers (cytokines, CRP) between day 1 and day 0 (first vaccination) and between day 60 and day 61 (second vaccination)
- Differential expression of innate and adaptive immune response genes measured by RNA sequencing (RNAseq), with the aim to compare gene profiles before and after vaccination (day 0 vs day 1, day 60 vs day 61), differences between responses to first, second (day 1 vs day 61) or subsequent doses, and after 1 month following the vaccination
- Kinetics of GMT of gE-specific IgG measured at day 0, 60, 90 and 360 to assess the persistence of the antibody response
- Kinetics of gE-specific CD4+ T cells expressing at least 2 activation markers (CD40L, IFNg, IL-2, TNFa) measured at day 0, 90, and 360 to assess the persistence of the T cell responses
- Change in disease activity evaluated at each visit using the Rheumatoid Arthritis Disease Activity Index (RADAI)(Stucki et al. 1995; Castrejón, Yazici, and Pincus 2013) for rheumatoid arthritis and psoriatic arthritis, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Garrett et al. 1994) for axial spondylarthritis (Appendix 2) and patient global assessment on a 0-10 scale.
- Monitoring of episodes of shingles throughout the study period
- ADCC (cytotoxicity), levels of isotypes, avidity levels before and after vaccination
- Differential expression of genes and epigenetic changes of specific innate cells (monocytes or NK cells), 1 month and 1 year post vaccination (compared to before vaccination)
- Changes in memory phenotypes, activation and transcription marker levels, TCR repertoire after RZV vaccination.
- Differences and similarities in levels of immune and inflammatory response post RZV vaccination and COVID-19 mRNA vaccines in individuals who were enrolled in study “Immunogenicity of RNA-based COVID-19 vaccines in patients treated with immunosuppressive drugs – a prospective observational cohort study” (CCER ##2021-00430)
- The level of JAKi will be measured by mass-spectrometry using an established and quantitative method and used to correlate with the vaccine response, including adaptive responses and reactogenicity
Investigators
principal investigator
Scientific
Centre Hospitalier Universitaire De Toulouse
Study Sites (2)
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