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

NCT03886038 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-06-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

Shingrix

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

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2022-02-15
Completion
2022-02-15

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886038 on ClinicalTrials.gov