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Virus Vaccine

Shingles Vaccines for Rheumatoid Arthritis (BMS-188667 Trial)

Phase 2
Waitlist Available
Research Sponsored by Kevin Winthrop
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be currently treated with abatacept therapy at the time of enrollment
be currently treated with abatacept therapy at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1) baseline visit prior to vaccination; 2) 6 weeks post-vaccination; 3) 1 year post-vaccination
Awards & highlights

BMS-188667 Trial Summary

This trial is designed to determine whether Zostavax or Shingrix are safe and effective in patients with rheumatoid arthritis (RA) currently using anti-tumor necrosis factor (TNF) therapies.

Who is the study for?
This trial is for rheumatoid arthritis patients aged 18+ for Shingrix and 50+ for Zostavax, using abatacept. Women must be post-menopausal or have had certain surgeries, or if of childbearing potential, use contraception and test negative for pregnancy. Exclusions include allergy to vaccine components, acute illness, HIV/AIDS, recent corticosteroids or anti-herpesvirus meds, cancer treatments affecting bone marrow/lymphatic system, recent live/inactivated vaccines.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of two shingles vaccines—Zostavax and Shingrix—in rheumatoid arthritis patients on abatacept therapy. It's a double-blinded trial where participants are randomly assigned to receive either the vaccine or a placebo injection without knowing which one they get.See study design
What are the potential side effects?
Previous data suggests side effects are mostly mild to moderate; however specific side effects aren't listed here. Generally speaking with vaccines like these you might expect soreness at the injection site, fatigue, headache or possibly an allergic reaction.

BMS-188667 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently being treated with abatacept.
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I am currently being treated with abatacept.
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I am a woman who has been post-menopausal for over a year or have had both ovaries or my uterus removed.
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I am a woman who has been post-menopausal for over a year or have had both ovaries or my uterus removed.
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I am a woman who can have children, used birth control for 30 days, tested negative for pregnancy, and will continue birth control for 2 months after my last vaccine.
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I am 50 years old or older.
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I am 18 years old or older.

BMS-188667 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1) baseline visit prior to vaccination; 2) 6 weeks post-vaccination; 3) 1 year post-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1) baseline visit prior to vaccination; 2) 6 weeks post-vaccination; 3) 1 year post-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ELISPOT response from baseline to week 6, and one year post vaccination
Change in IgG titer from baseline to week 6, and one year post vaccination
Secondary outcome measures
Development of Varicella Zoster Virus

BMS-188667 Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Varicella Zoster Vaccine (Zostavax)Experimental Treatment1 Intervention
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
Group II: Varicella Zoster Vaccine (Shingrix)Experimental Treatment1 Intervention
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
Group III: Placebo Injection (Shingrix Comparator)Placebo Group1 Intervention
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
Group IV: Placebo Injection (Zostavax Comparator)Placebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,382 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,386 Patients Enrolled for Rheumatoid Arthritis
University of Alabama at BirminghamOTHER
1,565 Previous Clinical Trials
2,268,204 Total Patients Enrolled
15 Trials studying Rheumatoid Arthritis
145,815 Patients Enrolled for Rheumatoid Arthritis
Kevin WinthropLead Sponsor
3 Previous Clinical Trials
635 Total Patients Enrolled

Media Library

Shingrix (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03604406 — Phase 2
Rheumatoid Arthritis Research Study Groups: Placebo Injection (Shingrix Comparator), Varicella Zoster Vaccine (Shingrix), Varicella Zoster Vaccine (Zostavax), Placebo Injection (Zostavax Comparator)
Rheumatoid Arthritis Clinical Trial 2023: Shingrix Highlights & Side Effects. Trial Name: NCT03604406 — Phase 2
Shingrix (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03604406 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment for this trial still open?

"Affirmative. According to the clinicaltrials.gov database, this research study is actively searching for new participants after it was published on May 8th 2014 and its most recent update occured on September 7th 2022. The goal of the trial is to recruit 130 individuals from 4 different medical sites."

Answered by AI

Are there any sites in North America that are presently administering this experiment?

"Presently, 4 locations are facilitating the trial: Hixson, Portland and Boise (as well as 4 additional sites). To reduce commuting demands, it is advised that potential participants select a clinic near to their residence."

Answered by AI

What potential risks come with taking the Varicella Zoster Vaccine?

"While Phase 2 trials provide some indication of safety, but lack efficacy data, our team at Power have assessed Varicella Zoster Vaccine's safety to be a score of 2."

Answered by AI

How many participants are there in this research trial?

"To run the trial, a total of 130 qualified patients must be enrolled. Bristol-Myers Squibb are managing this endeavour from multiple sites including Arthritis Associates in Hixson Tennessee and Oregon Health & Science University based in Portland, Oregon."

Answered by AI

What other research has been done concerning the Varicella Zoster Vaccine?

"The Varicella Zoster Vaccine was first trialled in 2007 at the Children's Hospital of Geneva (HUG). To date, 162 such studies have been completed and there are presently 26 active investigations. A substantial proportion of these experiments are conducted out of Hixson, Tennessee."

Answered by AI
~16 spots leftby Jun 2025