Safety and Immunogenicity of a Zoster Vaccine in SLE
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|ClinicalTrials.gov Identifier: NCT02477150|
Recruitment Status : Active, not recruiting
First Posted : June 22, 2015
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Biological: Zostavax Biological: placebo||Phase 4|
Herpes zoster (HZ) (Shingles) is a painful condition caused by reactivation of varicella zoster virus (VZV) that remains dormant after primary infection. HZ reactivation may cause significant morbidity such as post-herpetic neuralgia and even mortality for disseminated infection, particularly in immunocompromised individuals.
HZ vaccine (Zostavax) is essentially a larger-than-normal dose of the chickenpox vaccine, which contains the Oka strain of live attenuated VZV. Zostavax has been shown to be safe and protective in immunocompetent elderly populations (>60 years of age) by reducing reactivation of HZ by 51% and post-herpetic neuralgia by 66%. Another study also demonstrated efficacy of Zostavax in reducing HZ infection by 70% in adults aged 50-59 years.
Data regarding the use of HZ vaccine in patients with rheumatic diseases are scant. A recent observational study involving 463,541 US patients with rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis and ankylosing spondylitis showed that 4% of patients had received HZ vaccination. After a median observation period of 2 years, the rate HZ reactivation among vaccinated patients was significantly lower than that of unvaccinated group (hazard ratio 0.61 [0.52-0.71]). Among 633 patients exposed to biologics at the time of vaccination, no cases of HZ or varicella infection occurred in the subsequent 42 days after vaccination. Thus, the vaccine appears to be safe in patients with autoimmune rheumatic diseases even receiving the biological agents.
HZ reactivation is fairly common in patients with systemic lupus erythematosus (SLE).
However, data regarding HZ vaccination in SLE patients are generally lacking. Safety and efficacy of HZ vaccination has recently been demonstrated in other immunocompromised groups such as HIV infection, post-chemotherapy and hematological malignancies. According to the 2011 EULAR recommendation, HZ vaccination may be considered in patients with autoimmune inflammatory rheumatic diseases provided that they are less seriously immunosuppressed.
The current study is designed to test for the immunogenicity and safety of a HZ vaccine (Zostavax) in patients with stable SLE who are receiving minimal immunosuppressive therapies for maintenance.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||January 2019|
Active Comparator: SLE (vaccine)
Zostavax SC injection (0.65ml)
Vaccination of a zoster vaccine (Zostavax)
Placebo Comparator: SLE (placebo)
Placebo SC injection (normal saline 0.65ml)
- antibody rise to varicella zoster virus [ Time Frame: 6 weeks ]Difference between the two groups in the proportion of patients who achieve a two-fold rise in IgG to VZV at week 6 post-vaccination compared to baseline
- safety (incidence of herpes zoster reactivation or chickenpox infection) [ Time Frame: week 6 ]incidence of herpes zoster reactivation or chickenpox infection
- T cell response to VZV [ Time Frame: week 6 ]differences between IFN release upon VZV stimulation of PBMC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477150
|Department of Medicine, Tuen Mun Hospital|
|Hong Kong, China, 000|
|Principal Investigator:||CC Mok, MD||Tuen Mun Hospital|