Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Abatacept (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
David D. Hoelscher, MD, Principal Investigator, Affiliation: PPD
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.
Clinical Details
Official title:
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
Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary outcome: Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Qutintiles Phase I Services, Lenexa, Kansas, United States
Parexel International Corp, Baltimore, Maryland, United States
PPD Development, Austin, Texas, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Related publications: 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.
Starting date:
August 2004
Last updated: September 26, 2007
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