Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02477150
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2015-06-17
Brief Title:
Safety and Immunogenicity of a Zoster Vaccine in SLE
Sponsor:
Tuen Mun Hospital
Organization:
Tuen Mun Hospital
Study Overview
Official Title:
Immunogenicity and Safety of a Herpes Zoster Vaccine Zostavax in Patients With Systemic Lupus Erythematosus a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE
Detailed Description:
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 463541 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 061 052-071 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
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 463541 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 061 052-071 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None