Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
NCT ID: NCT00279734
Last Updated: 2011-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2004-08-31
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Tetanus + pnemococcal vaccines alone
0 mg + vaccines, Single dose, 28 days.
Group 2
Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Group 3
Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
Group 4
Abatacept + Vaccines
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
Interventions
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Tetanus + pnemococcal vaccines alone
0 mg + vaccines, Single dose, 28 days.
Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
Abatacept + Vaccines
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Qutintiles Phase I Services
Lenexa, Kansas, United States
Parexel International Corp
Baltimore, Maryland, United States
PPD Development
Austin, Texas, United States
Countries
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References
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Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38. doi: 10.1186/ar2174.
Other Identifiers
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IM101-049
Identifier Type: -
Identifier Source: org_study_id
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