The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept (BMS-188667)
Herpes Zoster, Inflammatory Disease, Rheumatoid Arthritis
About this trial
This is an interventional prevention trial for Herpes Zoster focused on measuring Shingles, abatacept, Varicella Zoster Vaccine
Eligibility Criteria
Inclusion criteria include:
- be >= 50 years of age or older (for the Zostavax® sub-study only)
- be >= 18 years of age or older (for the Shingrix® sub-study only)
- be currently treated with abatacept therapy at the time of enrollment
- Eligible women must be post-menopausal (> 1 year since last menstrual period) or have a surgical history of bilateral oophorectomy or hysterectomy (for the Zostavax® sub-study only).
- Female participants of childbearing potential may be enrolled in the study if the participant (for the Shingrix® sub-study only):
- Has practiced adequate contraception for 30 days prior to vaccination; and
- Has a negative urine pregnancy test on the day of the first vaccination; and
- Has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series (Week 16)
- Patients must have a history of prior chicken pox (for the Zostavax® sub-study only; for patients who do not recall prior chicken pox, a positive varicella IgG serology can be used to document prior exposure)
Exclusion criteria include:
- prior Zostavax® receipt (for the Zostavax® sub-study only; the Shingrix® sub-study will allow prior Zostavax® receipt if 6 months or greater prior to enrollment)
- active contraindications to vaccination including allergy or sensitivity to gelatin or any other vaccine component
- acute illness or infection
- HIV/AIDS
- current systemic corticosteroid use (including any oral or parenteral use in the previous 28 days) [NOTE: this exclusion applies only for the Zostavax® portion of the study]
- methotrexate use > 25 mg/week
- dose of DMARDs not stable for > 30 days
- concomitant TNF antagonist use
- receiving radiation or chemotherapy for cancer treatment
- current leukemia
- lymphoma, or other cancer affecting bone marrow or lymphatic system
- cellular immunodeficiency
- current use (within the last 30 days) of anti-viral medications against the herpesvirus family
- Received any live virus vaccine within 28 days prior to study entry (Zostavax® sub-study only)
- Administration or planned administration of any live vaccine <28 days before the first study vaccination or through 28 days after the second study vaccination (Shingrix ® sub-study only)
- received any inactivated vaccine within 7 days prior to study entry (Zostavax® sub-study only)
- Received any inactivated vaccine +/- 14 days of each study injection (Shingrix ® sub-study only)
- known household contacts who may be susceptible to a live virus vaccine (e.g. pregnant women) [NOTE: this exclusion for the Zostavax® sub-study only]
Sites / Locations
- St. Luke's Health SystemRecruiting
- St. Paul RheumatologyRecruiting
- Jayashree Sinha, MDRecruiting
- Oregon Health & Science UniversityRecruiting
- Arthritis AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Varicella Zoster Vaccine (Zostavax)
Placebo Injection (Zostavax Comparator)
Varicella Zoster Vaccine (Shingrix)
Placebo Injection (Shingrix Comparator)
Live zoster vaccine injection will be administered as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit
Saline injection will be administered as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit
Non-live zoster vaccine injection will be administered twice, 8 weeks apart, as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit
Saline injection will be administered twice, 8 weeks apart, as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit