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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

Must not have

receiving radiation or chemotherapy for cancer treatment

concomitant TNF antagonist use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1) baseline visit prior to vaccination; 2) 6 weeks post-vaccination; 3) 1 year post-vaccination

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing radiation or chemotherapy for cancer.

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I am currently using TNF blockers.

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I am living with HIV/AIDS.

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My condition affects my bone marrow or lymphatic system.

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I haven't received, nor plan to receive, any live vaccines around the time of the study vaccinations.

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I have leukemia.

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I am allergic to gelatin or another vaccine ingredient.

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I have not received a live virus vaccine in the last 28 days.

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I take more than 25 mg of methotrexate weekly.

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I do not have any current infections or sudden illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1) baseline visit prior to vaccination; 2) 6 weeks post-vaccination; 3) 1 year post-vaccination

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Development of Varicella Zoster Virus

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

0 / 14Eligibility criteria met