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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03604406
Date of registration: 05/07/2018
Prospective Registration: No
Primary sponsor: Kevin Winthrop
Public title: The Immunogenicity and Safety of Zostavax® in Rheumatoid Arthritis Patients Using Abatacept BMS-188667
Scientific title: The Immunogenicity and Safety of Zostavax® in Rheumatoid Arthritis Patients Using Abatacept
Date of first enrolment: May 8, 2014
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03604406
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Amanda Brunton, MPH
Address: 
Telephone: 503-494-6327
Email: brunton@ohsu.edu
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

- History of prior chicken pox (positive varicella IgG serology can be used to document
prior exposure)

Exclusion Criteria:

- Prior zostavax receipt

- 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)

- 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 of anti-viral medications against the herpes virus family

- Received any live virus vaccine within 28 days prior to study entry

- Received any inactivated vaccine within 7 days prior to study entry

- Known household contacts who may be susceptible to a live virus vaccine (e.g. pregnant
women).



Age minimum: 50 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Herpes Zoster
Inflammatory Disease
Rheumatoid Arthritis
Intervention(s)
Biological: Varicella Zoster Vaccine
Other: Placebo Injection
Primary Outcome(s)
Change in ELISPOT response from baseline to week 6, and one year post vaccination [Time Frame: 1) Baseline visit prior to vaccination; 2) 6 weeks post-vaccination; 3) 1 year post-vaccination]
Change in IgG titer from baseline to week 6, and one year post vaccination [Time Frame: 1) Baseline visit prior to vaccination; 2) 6 weeks post-vaccination; 3) 1 year post-vaccination]
Secondary Outcome(s)
Development of Varicella Zoster Virus [Time Frame: Within 42 days of vaccination]
Secondary ID(s)
10433
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
University of Alabama at Birmingham
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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