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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT03886038
• Date of registration: 02/01/2019
• Prospective Registration: Yes
• Primary sponsor: Region Skane
• Public title: Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER)
• Scientific title: The Immunogenicity and Efficacy of Subunit Vaccine Against Herpes Zoster in RA Treated With JAK-inhibitors (VACCIMIL-ZOSTER)
• Date of first enrolment: March 15, 2019
• Target sample size: 142
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03886038
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- pregnancy

- breastfeeding

- allergi against some of compnents in the vaccine

- ongoing infection



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Controls

Rheumatoid Arthritis

Intervention(s)

Biological: Shingrix

Primary Outcome(s)

the differences in the T cells response between the groups [Time Frame: 4-6 week after two vaccine doses]

the differences in serological response between the groups [Time Frame: 4-6 week after two vaccine doses]

Secondary Outcome(s)

the differences in antibody levels to glycoprotein E between the groups 3 and 5 after vaccination [Time Frame: up to 5 years after vaccination]

Secondary ID(s)

VACCIMIL-ZOSTER

Source(s) of Monetary Support

Please refer to primary and secondary sponsors