Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers

Study Overview
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Brief Summary
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Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.

Official Title
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An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Tetanus + pnemococcal vaccines alone
* Drug: Abatacept + vaccines
* Drug: Abatacept + vaccines
* Drug: Abatacept + Vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Subjects Body Weight between 60 and 100 kg. Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation. Exclusion Criteria: Females who are prgnant or breastfeeding History of autoimmune disorder, immunodeficiency, or infection within past 3 months. Active TB requiring treatment within the previous 3 years. Positive breast cancer screen, PPD test. Vaccination with tetanus or pneumococcal vaccine within 5 years. Vaccination with any live vaccine within 4 weeks. History of drug or alcohol abuse. Any significant allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Drug: Tetanus + pnemococcal vaccines alone<br>* 0 mg + vaccines, Single dose, 28 days.<br>|
| Active Comparator: Group 2<br> | Drug: Abatacept + vaccines<br>* Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.<br>* Other names: Orencia;|
| Active Comparator: Group 3<br> | Drug: Abatacept + vaccines<br>* Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.<br>* Other names: Orencia;|
| Active Comparator: Group 4<br> | Drug: Abatacept + Vaccines<br>* parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.<br>* Other names: Orencia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis