Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03886038 |
| Other study ID # |
VACCIMIL-ZOSTER |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2019 |
| Est. completion date |
February 15, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
Region Skane |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Background. Treatment with JAK-inhibitors has been shown to improve the signs and symptoms of
rheumatoid arthritis (RA) and delay the development of radiographic damage. However, these
remedies have been shown to increase risk of herpes zoster (HZ) infections in RA. Currently
available live attenuated vaccine against HZ is contraindicated in patients receiving
immunosuppressive treatments. A new subunit vaccine against HZ has recently been approved for
vaccination of adults in Sweden. This vaccine (Shingrix) has been shown to elicit 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 RA, are scarce.
Objectives. To investigate: 1) the immunogenicity of 2 doses of HZ vaccine (Shingrix)
administrated at least 2 months apart in patients with RA treated with JAK-inhibitors for at
least 3 months compared to immunogenicity of the vaccine given to healthy controls; 2) the
tolerability of subunit vaccine against HZ i.e. whether vaccination is associated with
increased disease activity, flare of RA or the onset of other autoimmune disease 3) long-term
immunogenicity of two doses of the subunit vaccine against HZ; 4) the impact of smoking
habits and alcohol consumption on the immunogenicity of vaccine and protection against HZ
infection 5) the efficacy of the vaccine in preventing HZ.
Methodology. Patients with RA, regularly followed at the Skåne University Hospital, section
for rheumatology already treated with JAK inhibitors for at least 3 months are eligible for
the study and will be offered to participate in the study. At vaccination, the clinical
examination is performed, and data on disease and treatment characteristics, co-morbidity,
smoking and alcohol habits are collected. All participants are encouraged to take the notice
of changes in the existing RA or other unexpected side effects following vaccinations. Blood
samples will be collected immediately before the first vaccination and 4-6 weeks after the
second dose of the vaccine and thereafter 3 and 5 years after vaccination. The levels of
antibodies to glycoprotein E (gE) using standard ELISA will be performed on the blood samples
collected at vaccination, 4-6 weeks following the second dose of the vaccine 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 register data on the corresponding infections among age- and sex- matched
non-vaccinated controls using data from the regional health and care registry in the Skåne
region, southern Sweden.
Impact. Results from this project will provide the evidence whether 2 doses of the subunit HZ
vaccine is immunogenic, safe and efficacious in patients with RA treated with JAK- inhibitors
and which factors can influence the efficacy of the vaccine. These results can be used for
the future recommendations on vaccination against HZ and when in relation to treatment the
immunization should be performed in order to reach the best protection. In the long term this
should result in decreased morbidity in HZ infections, complication of those infections and
lower health-care costs.
