CompletedPhase 1

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

United States80 participantsStarted 2004-08

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.

Trial details

NCT IDNCT00279734

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-01

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