The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept

Korábbi kezelés

• 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)
• current systemic corticosteroid use (including any oral or parenteral use in the previous 28 days) \[NOTE: this exclusion applies only for the Zostavax® portion of the study\]
• concomitant TNF antagonist use
• receiving radiation or chemotherapy for cancer treatment
• 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) \[NOTE: this exclusion for the Zostavax® sub-study only\]

Más betegség

• active contraindications to vaccination including allergy or sensitivity to gelatin or any other vaccine component
• acute illness or infection
• HIV/AIDS
• lymphoma, or other cancer affecting bone marrow or lymphatic system

Egyéb

• methotrexate use \> 25 mg/week
• dose of DMARDs not stable for \> 30 days
• current leukemia
• cellular immunodeficiency

• 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)